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Medical Devices
Provisions for Medical Device Registration
    Pubtime: 2012-03-20

Chapter I General Provisions

Article 1 These Provisions are formulated with the view to standardizing the administration on medical device registration and ensuring safety and effectiveness of medical devices in accordance with the Regulations for the Supervision and Administration of Medical Devices.

Article 2 Medical devices to be distributed or used within the territory of the People’s Republic of China shall be registered in accordance with the Provisions. Unregistered medical devices shall not be distributed or used.

Article 3 Medical device registration refers to the process for conducting systematic assessment, according to official procedures, on the safety and effectiveness of medical devices to be marketed and used, so as to decide whether or not to approve their marketing and use.

Article 4 The State administers a classified registration of medical devices.

A domestic Class I medical device shall be reviewed and, if approved, granted with a registration certificate by the (food and) drug regulatory authority of a municipality consisting of districts.

A domestic Class II medical device shall be reviewed, and, if approved, granted with a registration certificate by the (food and) drug regulatory authority of a province, autonomous region or municipality directly under the Central Government.

A domestic Class III medical device shall be reviewed, and, if approved, granted with a registration certificate by the State Food and Drug Administration.

An overseas medical device shall be reviewed, and, if approved, granted with a registration certificate by the State Food and Drug Administration.

Unless otherwise provided in the Provisions, the registration procedure of a medical device from Taiwan, Hong Kong, or Macao shall be referred to that of an overseas medical device registration.

A Medical Device Registration Certificate is valid for four years.

Article 5 Medical Device Registration Certificates shall be uniformly printed by the State Food and Drug Administration. The content shall be filled in by the (food and) drug regulatory authority which reviews and approves the products. The registration number is formed as the following:

×(×)1 (Shi)Yao Jian Xie (×2)Zi ××××3Di×4××5××××6Hao, in which

×(×)1 refers to the abbreviation for the place where (food and) drug regulatory department is located:

For a domestic Class III medical device, an overseas medical device, and a medical device from Taiwan, Hong Kong, or Macao, “Guo” is marked;

For a domestic Class II medical device, it is the abbreviation of the province, autonomous region, or municipality directly under the Central Government, where the (food and) drug regulatory department is located;

For a domestic Class I medical device, it is the abbreviation of the province, autonomous region, or municipality directly under the Central Government, where the (food and) drug regulatory department is located, plus the abbreviation of the local municipal administrative region consisting of districts, as ××1. (Where there is no such municipal administrative region consisting of districts, it is only the abbreviation of the province, autonomous region, or municipality directly under the Central Government);

×2 refers to the type of registration (Zhun, Jin, Xu):

“Zhun” applies to domestic medical devices;

“Jin (I: Import)” applies to overseas medical devices;

“Xu” applies to medical devices from Taiwan, Hong Kong, or Macao;

××××3 refers to the approval year of registration;

×4 refers to the product administrative classification;

××5 refers to the code of product category;

××××6 refers to the serial number of registration.

A Medical Device Registration Certificate is attached with a Medical Device Registration Form (see Appendix 1). The form shall be used together with the registration certificate.

Article 6 A manufacturer submits an application for medical device registration, takes relevant legal responsibilities, and is the holder of the Medical Device Registration Certificate which is granted. Persons engaged in application for the medical device registration shall be authorized by the medical device manufacturer and shall have relevant professional knowledge and be familiar with laws, regulations, provisions, and technical requirements on the administration of medical device registration.

As for registration application of an overseas medical device, an overseas manufacturer shall designate an agent located in China, which shall take relevant legal liabilities; and it shall authorize a legal person institution with relevant qualifications or its branch in China to provide after-sales service for the medical device.

Article 7 A medical device for registration shall have an applicable product standard, which can be national standard, industry standard or registration product standard established by the manufacturer. The registration product standard shall not be lower than national standard or industry standard.

Registration product standard shall be compiled in line with the administrative requirements of medical device standard specified by the State Food and Drug Administration.

Article 8 When applying for registration of a Class II or Class III medical device, the manufacturer shall meet the requirements of the State Food and Drug Administration on production conditions and related quality system.

Chapter II Registration Testing of Medical Devices

Article 9 Registration testing of Class II and Class III medical devices shall be conducted by medical device testing institutions recognized by the State Food and Drug Administration in conjunction with the General Administration of Quality Supervision, Inspection and Quarantine. Unless confirmed to meet the applicable product standard, a medical device shall not be used for clinical trial or apply for registration.

The list of medical device testing institutions recognized by the State Food and Drug Administration in conjunction with the General Administration of Quality Supervision, Inspection and Quarantine (medical device testing institutions for short) shall be promulgated separately.

Article 10 A medical device testing institution shall test medical devices for registration in accordance with its testing scope approved by the State Food and Drug Administration and the General Administration of Quality Supervision, Inspection and Quarantine, pursuant to the applicable product standards of the medical devices, including national standards, industry standards, or registration product standards established by the manufacturer, and shall provide the test report.

A Medical device that is not yet included in the approved testing scope of current medical device testing institutions shall be tested by a qualified testing institution with relevant capacity, which is appointed by the corresponding(food and) drug regulatory authority.

The registration testing of overseas medical devices shall be conducted in accordance with the Provisions for Registration Testing of Overseas Medical Devices.

Article 11 The product to be tested within one registration unit shall be the typical one representing the safety and effectiveness of the products in the unit.

Article 12 In re-registration of products of the same category made by one manufacturer with the same raw materials, if production processes and intended uses remain unchanged, biocompatibility test can be exempt from the biological evaluation of the products.

In registration of products of the same category made by one manufacturer with raw materials already passed the biological evaluation, if production processes and intended uses remain unchanged, or there is no newly-added potential biological risk, biocompatibility test can be exempt from the biological evaluation of the products.

Article 13 Where a Class II or Class III medical device is applied for registration, the registration testing can be exempt if the following requirements are all met:

1. The product to be registered belongs to the same category of those that have been approved for registration in basic mechanism, main functions, structure, materials, quality of materials, and intended uses;

2. The manufacturer has passed the inspection for good manufacturing system for the medical device or obtained a quality system certificate, and it can provide a testing report recognized by the original production condition inspection institution;

3. There are no changes affecting the safety and effectiveness of the medical device to be registered, in comparison with the manufacturer’ registered products of the same category that have passed the registration testing; or there are changes affecting safety and effectiveness but the changed parts and incidental changes in safety and effectiveness have passed the testing by a medical device testing institution;

4. Medical device adverse event monitoring has been conducted for registered products of the same category made by the manufacturer, and no severe adverse event is found;

5. In the past one year, there was no nonconformance record found in product quality sampling test(s) by a (food and) drug regulatory authority for registered products of the same category made by the manufacturer;

6. An overseas medical device has already been approved for marketing by the medical device regulatory authority of a foreign government.

Article 14 Where a Class II or Class III medical device is applied for re-registration, the registration testing can be exempt if the following requirements are all met:

1. The product to be re-registered belongs to the same category of those that have been approved for registration in basic mechanism, main functions, structure, materials, quality of materials, and intended uses;

2. The manufacturer has passed the inspection for good manufacturing system for the medical device or obtained a quality system certificate, and it can provide a testing report recognized by the original production condition inspection institution;

3. There are no changes affecting the safety and effectiveness of the medical device to be re-registered, in comparison with the manufacturer’ registered products of the same category that have passed the registration testing ; or there are changes affecting safety and effectiveness but the changed parts and incidental changes in safety and effectiveness have passed the testing by a medical device testing institution;

4. Medical device adverse event monitoring has been conducted for the re-registered product within the valid term of the original medical device registration certificate, and no adverse event is found;

5. In the past one year, there was no nonconformance record found in product quality sampling test(s) by a (food and) drug regulatory authority for the originally registered product.

Article 15 An overseas medical device that has a marketing authorization given by the medical device regulatory authority of a foreign government, and has special requirements on installation site and difficulties in testing, can request for a postponement of testing, so that the registration testing can be conducted after the registration certificate is obtained.

For a medical device that applies for a postponement of testing and obtains an approval for registration as prescribed in the previous paragraph, the manufacturer shall have the registration testing completed after the first set of device enters China but before it is put into use. It shall only be put into use after the testing is passed.

Chapter III Clinical Trial of Medical Devices

Article 16 To apply for registration of a Class II or Class III medical device, clinical trial data shall be submitted.

Clinical trial data shall be provided in accordance with the Sub-provisions for Clinical Trial Data for Medical Device Registration (see Appendix 12).

Article 17 When a medical device clinical trial is conducted in China, the Provisions for Medical Device Clinical Trials shall be strictly followed.

Article 18 Clinical trial documents of a medical device, of which the clinical trial is conducted in China, shall include the clinical trial contract, protocol and report.

When deeming as necessary, the (food and) drug regulatory department may request the manufacturer to submit notice of the clinical trial, letter of informed consent, and original record of the clinical trial.

Chapter IV Application and Approval of Medical Device Registration

Article 19 An applicant for medical device registration shall submit application to the (food and) drug regulatory department specified in Article 4 in accordance with the administrative classification of medical devices, and fill in an application form for medical device registration. The application dossier shall be provided in Chinese in accordance with the relevant requirements in Appendix 2, Appendix 3, Appendix 6, Appendix 8, or Appendix 9 in the Provisions. Original version in a foreign language shall be submitted along with its Chinese translation.

The instruction manual for medical device shall be provided in accordance with Provisions for the Instruction Manuals, Labels and Packaging Marks of Medical Devices.

The applicant shall be responsible for the truthfulness of the content of all application documents.

Article 20 The (food and) drug regulatory department shall handle applications respectively according to the following circumstances:

1. Where an application item is not subject to the jurisdiction of the concerned department, a non-acceptance decision shall be made at once and the applicant shall be informed to submit the application to the relevant administrative department;

2. Where in the dossier there is an error that can be corrected on-site, an on-site correction shall be allowed;

3 Where the dossier is either incomplete or nonconformed to the preliminary review requirements, the applicant shall be informed on-site or within five working days and given an one-off Notice for Supplementary Documents, defining what to be supplemented or corrected; if the applicant is not informed within the timeline, the application is regarded as accepted on the date the dossier is received;

4. Where the dossier is complete and conformed to the preliminary review requirements, or the applicant submits all the required supplementary or corrected documents, the registration application shall be accepted. Where the (food and) drug regulatory department accepts or decides not to accept a medical device registration application, it shall issue an Acceptance Notice or Non-Acceptance Notice with official stamp of the department and date of notice.

Article 21 Where the (food and) drug regulatory department accepts a medical device registration application, a substantive review on the application shall be conducted within the time limit prescribed in Article 22 and a written decision shall be made about whether or not to approve the registration. Where a medical device is confirmed to be qualified for registration, a Medical Device Registration Certificate shall be issued within 10 working days from the date the written decision is made. Where a medical device is confirmed to be unqualified for registration, a decision shall be made in writing with the reasons stated. Meanwhile, the applicant shall be informed of the right to apply for administrative reconsideration or bring an administrative suit by law.

Article 22 The (food and) drug regulatory department of a municipality consisting of districts shall decide whether or not to approve a registration within 30 working days from the date of acceptance.

The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall decide whether or not to approve a registration within 60 working days from the date of acceptance.

The State Food and Drug Administration shall decide whether or not to approve a registration within 90 working days from the date of acceptance.

During the period of reviewing the registration application, if any test, expert evaluation or hearing is needed, the period for such procedures shall not be included in the time limit stated in this article. The (food and) drug regulatory department shall inform the applicant of the length of time needed.

Article 23 The registration application of an overseas medical device without an overseas marketing authorization shall be handled in reference to the technical review requirements of registration for domestic products of the same category. (See Appendix 8 and Appendix 9 of the Provisions for the required documents to be submitted)

Article 24 The (food and) drug regulatory department shall issue an one-off written notice for supplementary document to the medical device manufacturer if the manufacturer is required to supplement documents for its registration application in the process of technical review.

The manufacturer shall submit all the documents as required in the notice at one time within 60 working days. The submission period shall not be included in the time limit of substantive review by the (food and) drug regulatory department. The review shall be terminated if the medical device manufacturer fails to submit the required documents within the specified time limit and has no proper reasons.

Article 25 Where a registration application is terminated, no application will be allowed within six months from the suspension.

Article 26 Where a manufacturer has any dissent on the content of Notice for Supplementary Documents, a written explanation with reasons and supporting technical data may be submitted to the (food and) drug regulatory department within the specified time limit. The (food and) drug regulatory department shall then review what has been submitted and make a decision.

Article 27 A medical device registration unit shall be principally defined on the basis of technical structure, performance parameters, and intended use.

Article 28 Where a device part is to be registered as a medical device, the applicant shall indicate the name, model, and specification of the intended product or part which the device part is to be used for. Where an entire device consists of registered parts, the device must also be registered.

Where an entire device is registered as a medical device, its main parts shall be listed in application for registration. If there is any change in the performance or specification of any of the parts, the device shall be re-registered.

Where an entire device is registered as a medical device, the parts listed in the column of product’s performance, structure, and components in the attached form to Medical Device Registration Certificate may be exempt from a separate registration when they are sold separately under the conditions that the way of combination and their intended use remain unchanged.

Article 29 The (food and) drug regulatory department shall put the requirements, procedures, and time limit of medical device registration, list of all the documents needed, and a model text of the application form on the official website and in the office area for medical device registration.

Article 30 The (food and) drug regulatory department shall publicize the progress and results in the process of the review and approval of medical device registration application. Applicants and interested parties may submit statements and arguments in writing about matters directly related to applicants’ critical interests.

Article 31 The State Food and Drug Administration shall regularly release to the public the information on registered medical devices on its website.

Article 32 Where a medical device registration application is of direct significance to the interests of the applicant and others, the (food and) drug regulatory department shall inform the applicant and interested parties of their rights to request for a hearing, in accordance with laws, regulations, and other provisions by the State Food and Drug Administration. During the registration review process, where the (food and) drug regulatory department considers a permission item is of significance to public interests,it shall announce it to the public and hold a hearing.

Chapter V Re-registration of Medical Devices

Article 33 Six months prior to the expiration of Medical Device Registration Certificate, an application shall be submitted for re-registration of the medical device if the manufacturer needs continuing to sell or use the medical device. If the manufacturer fails to apply before the deadline, the medical device shall undergo registration testing in its re-registration.

Article 34 Where there is a change concerning any of the following content of the Medical Device Registration Certificate, the manufacturer shall apply for re-registration for changes within 30 days from the date of change:

1. Model and specification;

2. Address of manufacturing site;

3. Product standards;

4. Performance, structure and components of product;

5. Applicable scope of product.

Article 35 Where the administrative classification of a product changes within the valid period of its Medical Device Registration Certificate, the manufacturer shall apply for re-registration as the changed classification within six months from the date of change to the relevant (food and) drug regulatory authority.

Article 36 When applying for medical device re-registration, the applicant shall fill in a medical device registration application form and submit application dossier to the (food and) drug regulatory department, in accordance with the relevant requirements in Appendix 4, Appendix 5, and Appendix 7 in the Provisions.

Where there are no other provisions in this chapter, the acceptance and approval procedures for re-registration shall be in compliance with the relevant provisions in Chapter IV.

Article 37 Re-registration of medical devices shall not be approved in any of the following circumstances:

1. Where the requirements raised at the time when registration certificate was issued by the (food and) drug regulatory departments in accordance with relevant provisions of the State Food and Drug Administration are not met;

2. Where the product is an obsolete one which is re-evaluated by the State Food and Drug Administration;

3. Where the Medical Device Registration Certificate is withdrawn in accordance with the Regulations for the Supervision and Administration of Medical Devices.

Chapter VI Change and Reissuance of Medical Device Registration Certificate

Article 38 Where any of the following changes occurs that affects the content of a Medical Device Registration Certificate, the manufacturer shall apply for change of certificate within 30 days from the date of change:

1. The name of manufacturer is changed but manufacturing entity remains unchanged;

2. The registered address of manufacturer is changed;

3. The text of the address of manufacturing site is changed

4. The text of product name or / and commercial name is changed

5. The text of model or/and specification is changed

6. The text of product standards’ name or code is changed

7. The agent is changed;

8. The after sales service agenct is changed.

Article 39 When applying for change of a Medical Device Registration Certificate, the applicant shall file an application form for the change and submit related materials with explanations to the original registration approval department (in accordance with Appendix 10 of the Provisions. The original registration approval department shall conduct a preliminary review on the submitted documents and inform the applicant on spot or within five working days of any needed supplementary documents. If the application meets the requirements, an Acceptance Notice shall be issued.

Article 40 The original registration approval department shall decide whether or not to approve the application for change in writing within 20 working days of acceptance of an application. If the application is approved upon review, a changed Medical Device Registration Certificate shall be issued and the original certificate shall be cancelled. If the application is found not in conformity with the requirements, a decision of disapproval shall be made in writing with reasons stated. Meanwhile, the department shall inform the applicant of the right to request for an administrative reconsideration or bring an administrative suit by law.

The changed Medical Device Registration Certificate shall adopt the original number, with the word “Geng” in parentheses added at the end of the original number.

The expiry date of the changed Medical Device Registration Certificate shall be the same with the date in the original Medical Device Registration Certificate. A re-registration application shall be filed upon the expiration.

Article 41 Where a Medical Device Registration Certificate is lost or damaged, the medical device manufacturer shall apply for a reissuance to the original registration approval department with related documents and statements in accordance with provisions in Appendix 11.

Chapter VII Supervision and Administration

Article 42 The (food and) drug regulatory department responsible for review and approval of medical device registration shall conduct review and approval in accordance with the specified procedures, and decide whether or not to approve a registration. Where a registration approval is against provisions, the administrative liabilities shall be investigated.

Article 43 Where a medical device registration conducted by a (food and) drug regulatory department of a municipality consisting of districts or higher is against the Provisions, the department shall be ordered by a higher (food and) drug regulatory department to correct its decision within a given time limit. If the registration is not corrected within such a time limit, the higher (food and) drug regulatory department shall withdraw the Medical Device Registration Certificate with a public notification. Where a Medical Device Registration Certificate is withdrawn, the device shall no longer be sold or used; if the device has already been sold or used, it shall be disposed of by the manufacturer under the supervision of the (food and) drug regulatory department at or above county level.

Article 44 The (food and) drug regulatory department at or above provincial level shall conduct technical re-evaluation on marketed medical devices. If any medical device fails to perform the intended use or ensure the effectiveness and safety of the device according to the result of the technical re-evaluation, the regulatory department shall make a decision to withdraw its registration certificate and issue a public announcement. Where the Medical Device Registration Certificate is withdrawn, the device shall no longer be sold and used; if the device has been sold and used, it shall be disposed of by the manufacturer under the supervision of the (food and) drug regulatory department at or above county level.

Article 45 The original registration approval department shall cancel a Medical Device Registration Certificate in any of the circumstance prescribed in Article 70 of the Administrative Permission Law of the People's Republic of China.

Chapter VII Legal Liabilities

Article 46 Where, in violation of the requirements in the Provisions, an applicant obtains a Medical Device Registration Certificate by providing false certificate(s), document(s) or samples, or by other illegal means, such as cheating or bribery, the registration approval department shall not accept or approve its registration application; a warning shall be given and no application for registration shall be accepted from this applicant within one year. Where an applicant already obtains a Medical Device Registration Certificate by cheating, the certificate shall be withdrawn, and no application for registration shall be accepted from this applicant within two years, and punishment shall be imposed in accordance with the provisions in Article 40 of the Regulations for the Supervision and Administration of Medical Devices.

Article 47 Anyone who alters, speculates, leases, lends, or by another illegal means transfers a Medical Device Registration Certificate shall be ordered to correct and fined no more than RMB 30,000 yuan by the (food and) drug regulatory authority at or above county level.

Article 48 Where, in violation of Article 33, Article 34, or Article 35 in the Provisions, anyone sells a medical device that fails to be legally re-registered, or a medical device that does not correspond with the content specified in the Medical Device Registration Certificate, or a medical device of which its instruction manual, label and packaging marks are not consistent with those specified in the Medical Device Registration Certificate, shall be punished by the (food and) drug regulatory authority at or above county level in accordance with provisions on punishment(s) on cases concerning not having a Medical Device Registration Certificate in the Regulations for the Supervision and Administration of Medical Devices.

Article 49 Where, in violation of Article 38 in the Provisions, a change of Medical Device Registration Certificate is not done in accordance with law, the one liable shall be ordered by the (food and) drug regulatory authority at or above county level to make correction within a time limit or be given a warning; failure to make correction within the time limit shall be fined no less than RMB 5,000 yuan but no more than RMB 10,000 yuan.

Article 50 Where for a medical device which should conduct a postponement testing after registration in accordance with Article 15 in the Provisions, the applicant put the product into use before completing the testing as required, the State Food and Drug Administration shall withdraw the Medical Device Registration Certificate, make an announcement to the public and enter into the credibility record of the applicant.

Where a product is found nonconforming during the registration testing, the State Food and Drug Administration shall withdraw the Medical Device Registration Certificate.

Chapter VII Supplementary Provisions

Article 51 Manufacturer refers to an organization that markets a product under his name and bears the ultimate legal liabilities for the product.

Article 52 Registered product refers to a medical device approved for registration with its instruction manual, label, and packaging mark(s) in compliance with the content specified in its registration certificate.

Article 53 Any medical device that is made within the valid period of its registration certificate is considered as a certified product.

Article 54 Provisions governing the registration of in vitro diagnostic reagents subject to administration of medical device registration shall be separately formulated by the State Food and Drug Administration.

Article 55 The Provisions shall be interpreted by the State Food and Drug Administration.

Article 56 The Provisions shall become effective as of the date of promulgation. The Provisions for Medical Device Registration, promulgated by the State Food and Drug Administration on April 5, 2000, shall be annulled there from.

Appendices:

1. Format of Medical Device Registration Form

2. Requirements for Application Documents for Domestic Class I Medical Device Registration

3. Requirements for Application Documents for Domestic Class II or/and Class III Medical Device Registration

4. Requirements for Application Documents for Domestic Class I Medical Device Re-registration

5. Requirements for Application Documents for Domestic Class II or/and Class III Medical Device Re-registration.

6. Requirements for Application Documents for Overseas Medical Device Registration

7. Requirements for Application Documents for Overseas Medical Device Re-registration

8. Requirements for Initial Application Documents for Registration of Overseas Class I Medical Devices Without Marketing Authorization

9. Requirements for Initial Application Documents for Overseas Class II or/and Class III Medical Devices Without Marketing Authorization

10. Requirements for Application Documents for Change in Medical Device Registration Certificate.

11. Requirements for Application Documents for Re-issuance of Medical Device Registration Certificate.

12. Sub-provisions on Clinical Trial Data for Medical Device Registration

Appendix 1:Format of Medical Device Registration Form

1.1 Registration Form of Domestic Medical Devices

Medical Device Registration Form

REG. NO.:×(×)1 (Shi)Yao Jian Xie (Zhun)Zi ××××3Di×4××5××××6Hao

Manufacturer

Registered Address of Manufacturer

Address of Manufacturing Site

Product Name

Model and Specification(s)

Product Standard

Performance, Structure and Components of the Product

Indications

Contraindications

Notes

Date

1.2 Registration Form of Import Medical Devices:

Medical Device Registration Form

REG. NO.: SFDA (I) ××××3×4××5××××6

Manufacturer

Registered Address of Manufacturer

Address of Manufacturing Site

Product Name

Model and Specification(s)

Product Standard

Performance, Structure and Components of the Product

Indications

Contraindications

Agent

Service Agent(s)

Notes

Date

1.3 Registration Form of Medical Devices Made in Taiwan, Hong Kong, and Macao:

Medical Device Registration Form

REG. NO.:Guo (Shi)Yao Jian Xie (Xu)Zi ××××3Di×4××5××××6Hao

Manufacturer

Registered Address of Manufacturer

Address of Manufacturing Site

Product Name

Model and Specification(s)

Product Standard

Performance, Structure and Components of the Product

Indications

Contraindications

Agent

Service Agent(s)

Notes

Date

Appendix 2:

Requirements for Application Documents for Domestic Class I Medical Device Registration

1. Registration form for domestic medical device;

2. Qualification certificate of medical device manufacturer: copy of business license;

3. Applicable product standard and description:

Where a national standard or industry standard is adopted as the applicable product standard, the manufacturer shall submit the text of the standard with the manufacturer’s signature and seal.

The manufacturer shall submit a statement indicating that the product complies with the national standard or industry standard, a declaration of the manufacturer’s responsibility for product quality after it goes into the market, and a description on determining product model and specifications.

“Signature and seal” here refers to the seal of the manufacturer, or the signature of the manufacturer’s legal representative or responsible person together with the seal of the manufacturer (“signature and seal” hereinafter in the provisions governing domestic medical devices means the same as of this term);

4. Testing report of product’s overall performance;

5. Description of current resources and quality management ability (including testing methods) of the manufacturer;

6. Medical device instruction manual;

7. Self-Guarantee Statement for the authenticity of the submitted documents :

including a list of the submitted documents and manufacturer’s promise to assume legal liabilities.

Appendix 3:

Requirements for Application Documents for Domestic Class II or/and Class III Medical Device Registration

1. Registration form for domestic medical device

2. Qualification certificate of medical device manufacturer:

Including copies of the Medical Device Manufacturing License and business license, and the product for registration shall be within the product scope specified in the Medical Device Manufacturing License;

3. Product technical report:

At least including the basis for determining technical parameters or main performance requirements.

4. Risk analysis report:

Written according to YY0316 Risk Analysis of Medical Devices, covering five aspects, i.e. energy hazard, biological hazard, environmental hazard, hazard in using the product, and hazard arising from the malfunctioning, improper maintenance, and aging of product, as well as related preventive measures;

5. Applicable product standard and description:

Where a national standard or industry standard is adopted as the applicable product standard, the manufacturer shall submit the text of the standard with the manufacturer’s signature and seal.

The manufacturer shall submit a statement indicating that the product complies with the national standard or industry standard, a declaration of the manufacturer‘s responsibility for product quality after it goes into the market, and a description on determining product model and specifications.

6. Self-testing report of product performance:

Self-testing items of product performance are the release test items specified in the registration product standard of the product. And the report shall be signed by the major examiner or main person in charge of the testing, and verifier. Where a national standard or industry standard is adopted, the manufacturer shall add its self-set release test item(s);

7. Product registration test report issued by a medical device testing institution:

Where a medical device needs a clinical trial, a test report issued by a medical device testing institution six months prior to the clinical trial shall be submitted. Where a medical device does not need a clinical trial, a test report issued by a medical device testing institution one year prior to the acceptance of the registration application shall be submitted.

Where Article 11 to 14 of the Provisions are applied, the corresponding explanation documents shall be provided.

8. Medical device clinical trial data (See Appendix 12 for specific mode of submission );

9. Medical device instruction manual;

10. Valid documents proving product quality system examination (certification):a specific quality system examination report shall be submitted in accordance with the requirements for different product:

10.1 A valid quality system examination report with the signature and seal of the (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government;

10.2 An examination report of good manufacturing system for the medical device or a medical device quality system certificate ;

10.3 Where a Detailed Manufacturing Implementation Rules is applied to the product by the State, an inspection and acceptance report on the implementation of the rules shall be submitted

11. Self-Guarantee Statement for the authenticity of the submitted documents :

including a list of the submitted documents and manufacturer’s promise to assume legal liabilities.

Appendix 4:

Requirements for Application Documents for Domestic Class I Medical Device Re-registration

1. Registration form for domestic medical device;

2. Qualification certificate of medical device manufacturer: including copy of business license;

3. Original Medical Device Registration Certificate:

For any of the circumstances as prescribed in Article 33 of Chapter V, the original Medical Device Registration Certificate shall be submitted; for any of the circumstances as prescribed in Article 34 and Article 35 of Chapter V, the original Medical Device Registration Certificate shall be submitted;

4. Applicable product standard and description:

Where a national standard or industry standard is adopted as the applicable product standard, the manufacturer shall submit the text of the standard with the manufacturer’s signature and seal.

The manufacturer shall submit a statement indicating that the product complies with the national standard or industry standard, a declaration of the manufacturer‘s responsibility for product quality after it goes into the market, and a description on determining product model and specifications.

5. Product quality tracing report;

6. Medical device instruction manual ;

7. For any of the circumstances as prescribed in Article 34 of Chapter V, related information and proof documents shall be submitted;

8. Self-Guarantee statement for the authenticity of the submitted documents :

including a list of the submitted documents and manufacturer’s promise to assume legal liabilities.

Appendix 5:

Requirements for Application Documents for Domestic Class II or/and Class III Medical Device Re-registration

1. Registration form for domestic medical devices

2. Qualification certificate of medical device manufacturer:

including copies of the Medical Device Manufacturing License and business license, and the product to be re-registered shall be within the product scope specified in the Medical Device Manufacturing License;

3. Original Medical Device Registration Certificate:

For any of the circumstances as prescribed in Article 33 of Chapter V, the original Medical Device Registration Certificate shall be submitted; for any of the circumstances as prescribed in Article 34 and Article 35 of Chapter V, the original Medical Device Registration Certificate shall be submitted;

4. Product registration test report issued by a medical device testing institution:

Where a medical device needs a clinical trial, a test report issued by a medical device testing institution six months prior to the clinical trial shall be submitted. Where a medical device does not need a clinical trial, a test report issued by a medical device testing institution one year prior to the acceptance of the registration application shall be submitted.

Where Article 11 to 14 of the Provisions are applied, the corresponding explanation documents shall be provided.

5. Applicable product standard and description:

Where a national standard or industry standard is adopted as the applicable product standard, the manufacturer shall submit the text of the standard with the manufacturer’s signature and seal.

The manufacturer shall submit a statement indicating that the product complies with the national standard or industry standard, a declaration of the manufacturer‘s responsibility for product quality after it goes into the market, and a description on determining product model and specifications.

6. Product quality tracing report:

A product quality tracing report provided by Medical device manufacturer on the use of the product in medical institutions in China, including statement about the monitoring of adverse events;

7. Medical device instruction manual;

8. Valid documents proving product quality system examination (certification): a specific quality system examination report shall be submitted in accordance with the requirements for different product:

8.1 A valid quality system examination report with the signature and seal of the (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government;

8.2 An examination report of good manufacturing system for the medical device or a medical device quality system certificate;

8.3 Where a Detailed Manufacturing Implementation Rules is applied to the product by the State, an inspection and acceptance report on the implementation of the rules shall be submitted.

9. For any of the circumstances as prescribed in Article 34 of Chapter V, related information and proof documents shall be submitted;

10. Self-Guarantee statement for the authenticity of the submitted documents:

Including a list of documents and manufacturer’s promise to assume legal liabilities.

Appendix 6:

Requirements for Application Documents for Overseas Medical Device Registration

1. Registration form for overseas medical devices;

2. Qualification certificate of medical device manufacturer;

3. Counterpart of applicant’s business license and letter of authorization granted by the manufacturer to the application agent;

4. A document proving that the product is recognized or approved, by the competent authority for medical devices of an overseas government, as a medical device to enter the market of the country (region).

5. Applicable product standard

Where the Chinese national standard or industry standard is adopted as the applicable product standard, the text of the said standard shall be submitted; the registration product standard shall have the signature and seal of the manufacturer, its representative office in China or the organization entrusted by the manufacturer with drafting of the standard. The letter of authorization for drafting the standard shall indicate “the manufacturer is responsible for product quality”.

The manufacturer shall submit a statement indicating that the product complies with the national standard or industry standard, a declaration of the manufacturer‘s responsibility for product quality after it goes into the market, and a description on determining product model and specifications.

“Signature and seal” here refers to the seal of the manufacturer, or the signature of the manufacturer’s legal representative or responsible person together with the seal of the manufacturer (“signature and seal” hereinafter in the provisions governing domestic medical devices means the same as of this term);

6. Medical device instruction manual:

Instruction manual for a Class II or Class III medical device shall be signed by the manufacturer or its representative office in China. Instruction manual for a Class I medical device does not need a signature and seal;

7. Product registration testing report issued by a medical device testing institution (applicable to a Class II or Class III medical device):

In case of a medical device subjects to a clinical trial, a test report issued by a medical device testing institution six months prior to the clinical trial shall be submitted. In case of a medical device does not need a clinical trial, a test report issued by a medical device testing institution one year prior to the acceptance of the registration application shall be submitted.

Where Articles 11 to 14 of the Provisions are applied, the corresponding explanation documents shall be provided.

Where Article 15 is applied, the manufacturer shall apply for a postponement registration testing, assuring that the testing shall be completed before its first product is put into use in China.

8. Medical device clinical trial data (See Appendix 12 for specific mode of submission);

9. Manufacturer's letter of guarantee for product quality:

To guarantee that the quality of the product to be registered, sold, and used in China is the same with the quality of the same product marketed in the country (region) of origin under the approval from the medical device competent authority of that country (region);

10. Letter of authorization for the agent appointed by the manufacturer, the agent’s letter of commitment and business license or organization registration record:

The content in the agent’s letter of commitment shall be in conformity with the content in the manufacturer’s letter of authorization. The agent shall guarantee in the letter of commitment that it will take the responsibility to report the medical device adverse events and to contact the (food and) drug regulatory departments;

11. Letter of authorization for designated after-sales service agent in China, the service agent’s letter of commitment and qualification certification:

The letter of authorization shall be provided by the manufacturer, with the product name specified. In case of level-by-level authorizations, each authorizer shall submit a document of recognition by the manufacturer.

The content in the letter of commitment by the after-sales agent shall be consistent with the content in the manufacturer’s letter of authorization.

The service agent’s qualification certification is the business license (its business scope shall cover related technical service items) or the registration certification of the manufacturer’s China branch;

12. Self-Guarantee statement for the authenticity of the documents submitted by the manufacturer or its China representative office, including a list of documents and its promise to assume legal liabilities.

Each document mentioned above shall have a Chinese version. Copies of certifications of items (2) and (4) in this appendix are accepted, but the seal and signature of the original issuing authority are required, or the copies shall be notarized by a local notarization office; unless otherwise provided herein, other documents in the appendix shall be the original ones with the seal and signature of the manufacturer, its local office or representative office in China.

Appendix 7:

Required Application Documents for Re-registration of Import Medical Devices

1. Registration form for overseas medical devices;

2. Qualification certificate of medical device manufacturer;

3. Original Medical Device Registration Certificate:

4. For any of the circumstances as prescribed in Article 33 of Chapter V, the original Medical Device Registration Certificate shall be submitted; for any of the circumstances as prescribed in Article 34 and Article 35 of Chapter V, the original Medical Device Registration Certificate shall be submitted; A document(s) proving that the competent authority for medical devices of an overseas government recognizes or approves such product as a medical device to enter the market of the country (region).

5. Applicable product standard and description:

Where the Chinese national standard or industry standard is adopted as the applicable product standard, the text of the said standard shall be submitted; the registration product standard shall have the signature and seal of the manufacturer, its representative office in China or the organization entrusted by the manufacturer with drafting of the standard. The letter of authorization for drafting the standard shall indicate “the manufacturer is responsible for product quality”.

6. The manufacturer shall submit a statement indicating that the product complies with the national standard or industry standard, a declaration of the manufacturer‘s responsibility for product quality after it goes into the market, and a description on determining product model and specifications. Medical device instruction manual:

Instruction manual for a Class II or Class III medical device shall be signed by the manufacturer or its representative offices in China. Instruction manual for a Class I medical device does not need a signature and seal;

7. Product registration testing report issued by a medical device testing institution (applicable to a Class II or Class III medical device):

In case of a medical device subjects to a clinical trial, a test report issued by a medical device testing institution six months prior to the clinical trial shall be submitted. In case of a medical device does not need a clinical trial, a test report issued by a medical device testing institution one year prior to the acceptance of the registration application shall be submitted.

Where Articles 11 to 14 of the Provisions are applied, the corresponding explanation documents shall be provided. Related recognition reports shall be submitted where the Item 2 in Article 10 of the Provisions for Registration Testing of Import Medical Devices is applied;

8. Product quality tracing report:

A product quality tracing report provided by the manufacturer on the use of the product in medical institutions in China, including statement about the monitoring of adverse events;

9. Manufacturer's letter of guarantee for product quality:

To guarantee that the quality of the product to be registered, sold, and used in China is the same with the quality of the same product marketed in the country (region) of origin under the approval from the medical device competent authority of the country (region);

10. Letter of authorization for the agent that is appointed by the manufacturer, the agent’s letter of commitment and business license or organization registration record:

The content in the agent’s letter of commitment shall be in conformity with the content in the manufacturer’s letter of authorization. The agent shall guarantee in the letter of commitment that it will take the responsibility to report medical device adverse events and to contact the (food and) drug regulatory departments;

11. Letter of authorization for designated after-sales service agent in China, the service agent’s letter of commitment and qualification certification:

The letter of authorization shall be provided by the manufacturer, with the product name specified. In case of level-by-level authorizations, each authorizer shall submit a document of recognition by the manufacturer.

The content in the letter of commitment by the after-sales agent shall be consistent with the content in the manufacturer’s letter of authorization.

The service agent’s qualification certification is the business license (its business scope shall cover related technical service items) or the registration certification of the manufacturer’s China branch;

12. For any of the circumstances as prescribed in Article 34 of Chapter V, related information and proof documents shall be submitted;

13. Self-Guarantee statement for the authenticity of the documents submitted by the manufacturer or its China representative office, including a list of documents and its promise to assume legal liabilities.

Each document mentioned above shall have a Chinese version. Copies of certifications of items (2) and (4) in this appendix are accepted but they shall be notarized by a local notarization office; unless otherwise provided herein, other documents in the appendix shall be the original ones with the seal and signature of the manufacturer, its local office or representative office in China.

Appendix 8:

Requirements for Application Documents for Initial Registration of Overseas Class I Medical Devices Without an Overseas Marketing Authorization

1. Registration form for import medical devices;

2. Qualification certificate of medical device manufacturer;

3. Applicable product standard and description:

Where the Chinese national standard or industry standard is adopted as the applicable product standard, the text of the said standard shall be submitted; the registration product standard shall have the signature and seal of the manufacturer, its representative office in China or the organization entrusted by the manufacturer with drafting of the standard. The letter of authorization for drafting the standard shall indicate “the manufacturer is responsible for product quality”.

The manufacturer shall submit a statement indicating that the product complies with the national standard or industry standard, a declaration of the manufacturer‘s responsibility for product quality after it goes into the market, and a description on determining product model and specifications.

4. Testing report of product’s overall performance;

5. Description of current resources and quality control ability (including testing methods) of the manufacturer;

6. Instruction manual for medical device (no seal or signature is required)

7. Letter of authorization for the agent appointed by the manufacturer, the agent’s letter of commitment and business license or organization registration record: the content in the agent’s letter of commitment shall be in conformity with the content in the manufacturer’s letter of authorization. The agent shall guarantee in the letter of commitment that it will take the responsibility to report medical device adverse events and to contact the (food and) drug regulatory departments;

8. Letter of authorization for designated after-sales service agent in China, the service agent’s letter of commitment and qualification certification:

The letter of authorization shall be provided by the manufacturer, with the product name specified. In case of level-by-level authorizations, each authorizer shall submit a document of recognition by the manufacturer.

The content in the letter of commitment by the after-sales agent shall be consistent with the content in the manufacturer’s letter of authorization.

The service agent’s qualification certification is the business license (its business scope shall cover related technical service items) or the registration certification of the manufacturer’s China branch;

9. Self-Guarantee statement for the authenticity of the documents submitted by the manufacturer or its China representative office, including a list of documents and its promise to assume legal liabilities.

Each document mentioned above shall have a Chinese version. Copies of certifications of item (2) in this appendix are accepted, but the copies shall be notarized by a local notarization office; unless otherwise provided herein, other documents in the appendix shall be the original ones with the seal and signature of the manufacturer, its local office or representative office in China.

Appendix 9:

Requirements for Application Documents for Initial Registration of Overseas Class II or/and Class III Medical Devices Without an Overseas Marketing Authorization

1. Registration form for overseas medical devices;

2. Qualification certificate of medical device manufacturer;

3. Product technical report :

4. At least including the basis for determining technical parameters or main performance requirements. Risk analysis report on product safety:

Written according to YY0316 Risk Analysis of Medical Devices, covering five aspects, i.e. energy hazard, biological hazard, environmental hazard, hazard in using the product, and hazard arising from the malfunctioning, improper maintenance, and aging of product, as well as related preventive measures; Applicable product standard and description:

5. Where the nation standard or industry standard is adopted as the applicable product standard, the manufacturer shall submit the text of the standard with the manufacturer’s signature and seal; the registration product standard shall have the signature and seal of the manufacturer, its representative office in China or the organization entrusted by the manufacturer with drafting of the standard. The letter of authorization for drafting the standard shall indicate “the manufacturer is responsible for product quality”. .

The manufacturer shall submit a statement indicating that the product complies with the national standard or industry standard, a declaration of the manufacturer‘s responsibility for product quality after it goes into the market, and a description on determining product model and specifications.

6. Self-testing report of product performance:

Self-testing items of product performance are the release test items specified in the registration product standard of the product. And the report shall be signed by the major examiner or main person in charge of the testing, and verifier. Where the national standard or industry standard is adopted, the manufacturer shall add the self-set release test items;

7. Product registration testing report issued by a medical device testing institution (applicable to Class II or/and Class III medical devices):

In case of a medical device subjects to a clinical trial, a test report issued by a medical device testing institution six months prior to the clinical trial shall be submitted. Where a medical device does not need a clinical trial, a test report issued by a medical device testing institution one year prior to the acceptance of the registration application shall be submitted;

Where Articles 11 to 14 of the Provisions are applied, the corresponding explanation documents shall be provided. Related recognition reports shall be submitted where the Item 2 in Article 10 of the Provisions for Registration Testing of Import Medical Devices is applied;

8. Medical device clinical trial data (See Appendix 12 for specific mode of submission);

9. Medical device instruction manual (the seal and signature of the manufacturer or its representative office in China is required);

10. Valid documents proving product quality system examination (certification): The quality system examination report on the medical device to be registered by the State Food and Drug Registration shall be submitted.

11. Letter of authorization for the agent that is appointed by the manufacturer, the agent’s letter of commitment and business license or organization registration record:

The content in the agent’s letter of commitment shall be in conformity with the content in the manufacturer’s letter of authorization. The agent shall guarantee in the letter of commitment that it will take the responsibility to report medical device adverse events and to contact the (food and) drug regulatory departments;

12. Letter of authorization for designated after-sales service agent in China, the service agent’s letter of commitment and qualification certification:

The letter of authorization shall be provided by the manufacturer, with the product name specified. In case of level-by-level authorizations, each authorizer shall submit a document of recognition by the manufacturer;

The content in the letter of commitment by the after-sales agent shall be consistent with the content in the manufacturer’s letter of authorization;

The service agent’s qualification certification is the business license (its business scope shall cover related technical service items) or the registration certification of the manufacturer’s China branch;

13. Self-Guarantee statement for the authenticity of the submitted documents or its China representative office, including a list of documents and its promise to assume legal liabilities.

Each document mentioned above shall have a Chinese version. Copies of certifications of item (2) in this appendix are accepted, but the copies shall be notarized by a local notarization office; unless otherwise provided herein, other documents in the appendix shall be the original ones with the seal and signature of the manufacturer, its local office or representative office in China.

Appendix 10:

Requirements for Application Documents for Change in Medical Device Registration Certificate

1. Requirements for application documents for change of manufacturer’s name:

1.1 Original Medical Device Registration Certificate (to submit a copy of the certificate when applying for the change, and to return the original one after the changed registration certificate is received);

1.2 New Manufacturing Enterprise License for Medical Devices (applicable to a domestic Class II or/and Class III medical device);

1.3 New business license (applicable to a domestic medical device);

1.4 New legal qualification certification of the manufacturer (applicable to an overseas medical device);

1.5 New product standard (applicable to change in product);

1.6 The manufacturer’s description and related proof document(s) about the change;

1.7 Self-Guarantee statement for the authenticity of the submitted documents :

A list of the documents and manufacturer’s promise to assume legal responsibilities shall be submitted. Where there is a change to an Import Medical Device Registration Certificate, the manufacturer or its China representative office shall issue the statement.

2. Requirements for application documents for change of words in product name, trade name, model, specifications, title of product standard or symbol:

2.1 Original Medical Device Registration Certificate (to submit a copy of the certificate when applying for the change, and to return the original one when the changed registration certificate is received);

2.2 New product standard;

2.3 Medical device instruction manual;

2.4 The manufacturer’s description and relevant proof materials of the change;

2.5 Self-Guarantee statement for the authenticity of the submitted documents:

A list of the documents and manufacturer’s promise to assume legal responsibilities shall be submitted. Where there is a change to an Import Medical Device Registration Certificate, the manufacturer or its China representative office shall issue the statement.

3. Requirements for application documents for change of registered address of the manufacturer and change of words in the address of manufacturing site:

3.1 Original Medical Device Registration Certificate (to submit a copy of the certificate when applying for the change, and to return the original one when the changed registration certificate is received);

3.2 New Manufacturing Enterprise License (applicable to a domestic Class II or/and Class III medical device);

3.3 New business license (applicable to a domestic medical device);

3.4 The manufacturer’s description and relevant proof materials of the change;

3.5 Statement about the address change of the manufacturer (applicable to an import medical device);

3.6 Self-Guarantee statement for the authenticity of the submitted documents:

A list of the documents and manufacturer’s promise to assume legal responsibilities shall be submitted. Where there is a change to an Import Medical Device Registration Certificate, the manufacturer or its China representative office shall issue the statement.

4. Requirements for application documents for change of agent in an import medical device registration certificate:

4.1 Original Medical Device Registration Certificate (to submit a copy of the certificate when applying for the change, and to return the original one when the changed registration certificate is received);

4.2 Manufacturer’s announcement about the change of agent;

4.3 Manufacturer’s letter of authorization to the new agent;

4.4 Business license or registration certificate of the new agent;

4.5 The new agent’s letter of commitment to accept the authorization and to be responsible for corresponding liabilities;

4.6 Self-Guarantee statement for the authenticity of the documents submitted:

Provided by the manufacturer or its representative office in China, including a list of the documents and manufacturer’s promise to assume legal responsibilities.

5. Requirements for application documents for change of after-sales service agent in an import medical device registration certificate:

5.1 Original Medical Device Registration Certificate (to submit a copy of the certificate when applying for the change, and to return the original one when the changed registration certificate is received);

5.2 Manufacturer’s statement about the change or addition of after-sales service agent;

5.3 Manufacturer’s letter of authorization to the changed or added after-sales service agent;

5.4 Manufacturer’s treatment and promise regarding after-sales service of the already-sold product;

5.5 Business license or registration certificates of the changed or added service agent;

5.6 The changed or added service agent’s letter of commitment to be responsible for after-sales service;

5.7 Self-Guarantee statement for the authenticity of the submitted documents:

Provided by the manufacturer or its representative office in China, including a list of the documents and manufacturer’s promise to assume legal responsibilities.

Appendix 11:

Requirements for Application Documents for Re-issuance of Medical Device Registration Certificate

1. Reasons and explanation for re-issuance application of a Medical Device Registration Certificate

2. Applicant’s qualification certification;

3. Copies of the Medical Device Registration Certificate and appendixes;

4. Self-Guarantee statement for the authenticity of the submitted documents :

Including a list of the submitted documents and manufacturer’s promise to assume legal responsibilities. Where an Import Medical Device Registration Certificate is to be reissued, the manufacturer or its representative office in China shall issue the statement.

Appendix 12:

Sub-provisions on Clinical Trial Data for Medical Device Registration

Product

Classification

Situations

Conditions

Mode of Clinical Trial Data Submission

Class III Product

1. All Situations

An overseas product not yet approved by the medical device regulatory authority of the country (region) of origin for marketing.

To submit data of clinical trial conducted in China.

Class III Implantable Product

2. The manufacturer has never had a product marketed in China

A domestic product not yet approved for marketing in China, or an overseas product already approved by the medical device regulatory authority of the country (region) of origin for marketing.

To submit data of clinical trial conducted in China.

2. The manufacturer has (a) product (s) marketed in China.

A. Meeting both conditions:

1. A domestic product not yet approved for marketing in China, or an overseas product approved by the medical device regulatory authority of the country (region) of origin for marketing;
2. The Chinese Government has audited the quality system of the manufacturer but not covering the product.

For a domestic product, clinical trial data shall be submitted in accordance with related requirements;
For an overseas product, clinical trial data submitted at the time the product was registered for marketing by the medical device regulatory authority of the country (region) of origin shall be recognized by a specialist group organized by the Chinese Government.

B. Meeting all conditions:

1. A domestic product not yet approved for marketing in China, or an overseas product approved by the medical device regulatory authority of the country (region) of origin for marketing;
2. The quality system approved by the Chinese government covers the product, and is within the valid period;

3. No record of complaints against other products of the manufacturer with a sale history in China for more than four years.

Note: if there is a record of complaint, item A shall apply.

For a domestic product, clinical trial data shall be submitted in accordance with related requirements;

For an overseas product, clinical trial data at the time the product was registered for marketing by the medical device regulatory authority of the country (region) of origin shall be submitted.

3. The manufacturer has (a) product (s) marketed in China, and the product to be registered is of the same category but not the same model with the registered product(s) .

A. Meeting both conditions:

1. A domestic product not yet approved for marketing in China, or an overseas product approved by the medical device regulatory authority of the country (region) of origin for marketing; 2. The Chinese Government has audited the quality system of the manufacturer, but the model of the product to be registered is not covered.

For a domestic product, clinical trial data shall be submitted in accordance with related requirements;

For an overseas product, clinical trial data submitted at the time the product was registered for marketing by the medical device regulatory authority of the country (region) of origin shall be recognized by a specialist group organized by the Chinese Government.

B. Meeting all conditions:

1. A domestic product not yet approved for marketing in China, or an overseas product approved by the medical device regulatory authority of the country (region) of origin for marketing;
2. The quality system approved by the Chinese government covers the product, and is within the valid period;

3. No record of complaints against the other products of the manufacturer with a sale history in China for more than four years.

Note: if there is a record of complaint, item A shall apply.

For a domestic product, clinical trial data shall be submitted in accordance with related requirements;

For an overseas product, clinical trial data at the time the product was registered for marketing by the medical device regulatory authority of the country (region) of origin shall be submitted.

4. The manufacturer has (a) product (s) marketed in China

; the product to be registered is of the same model but not the same specifications with the registered product(s) of the manufacturer.

A. Meeting both conditions:

1. A domestic product not yet approved for marketing in China, or an overseas product approved by the medical device regulatory authority of the country (region) of origin for marketing;

2. The Chinese Government has audited the quality system of the manufacturer, but the specifications of the product to be registered are not covered.

For a domestic product, clinical trial data shall be submitted in accordance with related requirements;

For an overseas product, clinical trial data submitted at the time the product was registered for marketing by the medical device regulatory authority of the country (region) of origin shall be recognized by a specialist group organized by the Chinese Government.

B. Meeting all conditions:

1. A domestic product not yet approved for marketing in China, or an overseas product approved by the medical device regulatory authority of the country (region) of origin for marketing;

2. The quality system approved by the Chinese government covers the product, and is within the valid period;

3. No record of complaints against the other products of the manufacturer with a sale history in China for more than four years.

Note: if there is a record of complaint, item A shall apply.

For a domestic product, clinical trial data shall be submitted in accordance with related requirements;

For an overseas product, clinical trial data at the time the product was registered for marketing by the medical device regulatory authority of the country (region) of origin shall be submitted.

Other Class III Product

1. The manufacturer has never had a products marketed in China.

A domestic product not yet approved for marketing in China, or an overseas product already approved by the medical device regulatory authority of the country (region) of origin for marketing.

For a domestic product, clinical trial data shall be submitted in accordance with related requirements;

For an overseas product, clinical trial data submitted at the time the product was registered for marketing by the medical device regulatory authority of the country (region) of origin shall be recognized by a specialist group organized by the Chinese Government.

2. The manufacturer has had a product(s) marketed in China, and the product to be registered is an initial entry into the Chinese market

A. Meeting both conditions:

1. A domestic product not yet approved for marketing in China, or an overseas product already approved by the medical device regulatory authority of the country (region) of origin for marketing;

2. Treatment equipment using ultrasound, microwave, laser, X-ray, gamma ray, or other radioactive particles as sources of treatment.

For a domestic product, clinical trial data shall be submitted in accordance with related requirements;

For an overseas product, clinical trial data submitted at the time the product was registered for marketing by the medical device regulatory authority of the country (region) of origin shall be recognized by a specialist group organized by the Chinese Government.

B. Meeting all conditions:

1. A domestic product not yet approved for marketing in China, or an overseas product already approved by the medical device regulatory authority of the country (region) of origin for marketing.

2.Diagnostic equipment or treatment equipment without using ultrasound, microwaves, lasers, X-rays, gamma rays, or other ionic radiation/radioactive particle sources.

3. No record of complaints against the other products of the manufacturer with a sale history in China for more than four years.

Note: if there is a record of complaint, item A shall apply.

For a domestic product, clinical trial data shall be submitted in accordance with related requirements;

For an overseas product, clinical trial data at the time the product was registered for marketing by the medical device regulatory authority of the country (region) of origin shall be submitted.

3. The manufacturer has (a) product (s) marketed in China; the product to be registered is of the same category with the registered product(s) of the manufacturer.

A. Meeting both conditions:

1. A domestic product not yet approved for marketing in China, or an overseas product already approved by the medical device regulatory authority of the country (region) of origin for marketing;

2. Treatment equipment using ultrasound, microwave, laser, X-ray, gamma ray, or other radioactive particles as sources of treatment.

For a domestic product, clinical trial data shall be submitted in accordance with related requirements;

For an overseas product, clinical trial data submitted at the time the product was registered for marketing by the medical device regulatory authority of the country (region) of origin shall be recognized by a specialist group organized by the Chinese Government.

B. Meeting all conditions:

1. A domestic product not yet approved for marketing in China, or an overseas product approved by the medical device regulatory authority of the country (region) of origin for marketing;

2. No record of complaints against the other products of the manufacturer with a sale history in China for more than four years.

Note: if there is a record of complaint, item A shall apply.

Clinical trial data for registered product(s) of the same category of the manufacturer shall be submitted.

Class II Product

1. All Situations

A domestic product not yet approved for marketing in China, or an overseas product approved by the medical device regulatory authority of the country (region) of origin for marketing;

To submit documents of clinical trial conducted in China.

2. The product is an initial entry to the Chinese market.

A. An overseas product approved by the medical device regulatory authority of the country (region) of origin for marketing;

Clinical trial data at the time the product was registered for marketing by the medical device regulatory authority of the country (region) of origin shall be submitted.

B. For a domestic product, the products of the same category have been approved for marketing.

Clinical trial data of the product of the same category shall be submitted, as well as comparative explanation

C. A medical device for testing or diagnosis is subject to the national standard or industry standard.

Clinical trial data are not required.

Notes:

1. “Same category” refers to products that are the same in terms of mechanism, major functions, structure, materials, material quality, and intended uses. The specific catalogue shall be formulated and promulgated by the State Food and Drug Administration;

2. “Same model” means that when the products are the same in basic mechanism, major function(s) and structure, the basic mechanism and structure for auxiliary function(s) are also the same.

3. “Same specifications” means that when the products are the same in basic mechanism, major function(s) and structure, and in basic mechanism and structure for the auxiliary function(s), the parameters, indices, and geometric size of main performance of the product are also the same;

4. “Complaints” refers to cases accepted and handled by the State Food and Drug Administration, and the (food and) drug regulatory authority of a province, autonomous region or municipality directly under the central government, and defined with technical methods as adverse events caused by the quality reasons of a product;

5. Where clinical trial data within China are required, the data from at least two clinical trial bases shall be provided in accordance with the Provision On Medical Device Clinical Trials.
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