(Promulgated by Order No. 53 of the State Administration for Market Regulation on March 10, 2022 and effective from May 1, 2022)

Chapter 1 General Provisions

Article 1 In order to strengthen the supervision and management of medical device production, standardize medical device production activities, and ensure the safety and effectiveness of medical devices, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

Article 2 Those engaged in the production of medical devices and their supervision and administration within the territory of the People's Republic of China shall abide by these Measures.

Article 3 Those engaged in the production of medical devices shall abide by laws, regulations, rules, mandatory standards and medical device production quality management practices, and ensure that the information in the whole process of medical device production is true, accurate, complete and traceable.

Medical device registrants and filers are responsible for the safety and effectiveness of listed medical devices.

Article 4 According to the degree of risk of medical devices, the production of medical devices is subject to classified management.

To engage in the production activities of Class II and Class III medical devices, it shall be approved by the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where it is located, and obtain a medical device production license in accordance with the law; to engage in the production of Class I medical devices, it shall report to the districted medical device where it is located. The municipal department in charge of drug supervision and administration shall handle the filing of medical device production.

Article 5 The State Drug Administration is responsible for the supervision and administration of the national medical device production.

The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and administration of the production of Class II and Class III medical devices in their respective administrative regions, and are responsible for the supervision and administration of the production of Class I medical devices in their respective administrative regions in accordance with their duties in accordance with the law, and strengthen the supervision and administration of Class I medical devices in their respective administrative regions. Guidance for the supervision and management of medical device production.

The departments responsible for drug supervision and administration at the city level with districts shall supervise and manage the production activities of Class I medical devices in their respective administrative regions in accordance with their duties and responsibilities.

Article 6 The medical device review, inspection, inspection, monitoring and evaluation and other professional technical institutions established or designated by the drug regulatory department in accordance with the law shall undertake relevant technical work according to the division of responsibilities, and provide technical support for the supervision and management of medical device production.

The Food and Drug Review and Inspection Center of the State Drug Administration organizes the formulation of medical device inspection system specifications and technical documents, undertakes major cause-based inspections and overseas inspections, etc., and guides and evaluates the quality management systems of medical device inspection institutions in provinces, autonomous regions, and municipalities directly under the Central Government. .

Article 7 The State Drug Administration shall strengthen the informatization construction of medical device production supervision and management, and improve the level of online government services.

The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the informatization construction and management of medical device production supervision and management in their respective administrative regions, and coordinate and promote the sharing of medical device production supervision and management information in accordance with the requirements of the State Drug Administration.

Article 8 The drug regulatory department shall disclose information such as medical device production license, filing, supervision and inspection, and administrative punishment in a timely manner in accordance with the law, so as to facilitate public inquiry and accept social supervision.

Chapter II Production License and Filing Management

Article 9 To engage in medical device production activities, the following conditions shall be met:

(1) It has production sites, environmental conditions, production equipment and professional technicians that are compatible with the medical devices produced;

(2) There are institutions or full-time inspectors and inspection equipment that can conduct quality inspection of the medical devices produced;

(3) It has a management system to ensure the quality of medical devices;

(4) Having the after-sales service capability suitable for the medical devices produced;

(5) It meets the requirements of product development and production process documents.

Article 10 Those engaged in the production of Class II and Class III medical devices within the territory of China shall apply for a production license to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where they are located, and submit the following materials:

(1) A copy of the medical device registration certificate produced and the technical requirements of the product;

(2) A photocopy of the identity certificate of the legal representative (person in charge of the enterprise);

(3) Photocopies of the identity, educational background and professional title of the person in charge of production, quality and technology;

(4) List of academic qualifications and professional titles of employees in production management and quality inspection positions;

(5) Copies of relevant documents of the production site, and if there are special production environment requirements, copies of relevant documents of facilities and environment shall also be submitted;

(6) Catalogue of main production equipment and inspection equipment;

(7) Catalogue of quality manuals and program documents;

(8) Production process flow chart;

(9) Relevant materials proving the ability of after-sales service;

(10) Authorization documents of the handler.

The applicant shall ensure that the submitted materials are legal, authentic, accurate, complete and traceable.

If the relevant materials can be verified online, the applicant does not need to provide it.

Article 11 After receiving the application, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall deal with it according to the following circumstances:

(1) If the application matters fall within the scope of the administrative organ’s powers, and the application materials are complete and conform to the statutory form, the application shall be accepted;

(2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;

(3) If the application materials are incomplete or do not conform to the statutory form, the applicant shall be notified on the spot or within 5 working days of all the contents that need to be supplemented and corrected.

(4) If the application matters do not fall within the scope of the administrative organ's powers according to law, it shall immediately make a decision not to accept it, and inform the applicant to apply to the relevant administrative organ.

Where the drug regulatory department of a province, autonomous region or municipality directly under the Central Government accepts or rejects an application for a medical device production license, it shall issue a notification of acceptance or rejection affixed with the special seal of the administrative organ and dated.

Article 12 For the matters that laws, regulations and rules stipulate that the implementation of administrative licensing should be heard, or other major administrative licensing matters involving public interests that the drug supervision and administration department deems to require a hearing, the drug supervision and administration department shall announce to the public and hold a hearing. Where an application for a medical device production license directly involves a significant interest relationship between the applicant and others, the drug regulatory department shall inform the applicant and interested parties that they have the right to request a hearing before making an administrative licensing decision.

Article 13 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall review the application materials and conduct inspections in accordance with the requirements of the Good Manufacturing Practice for Medical Devices formulated by the State Drug Administration, and 20 working days from the date of accepting the application decision within. On-site inspections can be combined with product registration system inspections to avoid repeated inspections. If rectification is required, the rectification time is not included in the review time limit.

If the prescribed conditions are met, a written decision to grant the license shall be made in accordance with the law, and a "Medical Device Production License" shall be issued within 10 working days; The applicant has the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law.

Article 14 The medical device production license is divided into the original and the duplicate, and the validity period is 5 years. The original and duplicates shall specify the license number, enterprise name, unified social credit code, legal representative (person in charge of the enterprise), domicile, production address, production scope, issuing department, issuing date and validity period. The duplicate records the changes in the items stated in the original license and the major transformation of the workshop or production line. Items such as enterprise name, unified social credit code, legal representative (person in charge of the enterprise), and domicile shall be consistent with the relevant contents stated in the business license.

The medical device production license is unified by the State Drug Administration and printed by the drug administration department of the province, autonomous region, and municipality directly under the Central Government.

The electronic certificate of medical device production license has the same legal effect as the paper certificate.

Article 15 If the production address is changed or the production scope is increased, the original license-issuing department shall apply to the original license-issuing department for the modification of the medical device production license, and submit the relevant materials related to the content of the change as stipulated in Article 10 of these Measures. The original license-issuing department shall comply with Article 10 of these Measures. Article 13 shall be reviewed and on-site inspection shall be carried out.

If the workshop or production line is modified, resulting in changes in production conditions, which may affect the safety and effectiveness of medical devices, it shall be reported to the original licensing department. In the event of a change in licensing matters, the relevant licensing change procedures shall be handled in accordance with the regulations.

Article 16 If the name of the enterprise, legal representative (person in charge of the enterprise), domicile is changed or the production address is changed in words, and the production scope is reduced after verification, it shall apply to the original license-issuing department for change of registration items within 30 working days after the change. and submit relevant materials. The original license-issuing department shall complete the change of registration items within 5 working days.

Article 17 Where a medical device production license is to be renewed upon expiration of the validity period, an application for renewal shall be filed within 90 working days to 30 working days before the expiration of the validity period. If the renewal application is not submitted within the time limit, the renewal application will not be accepted.

The original license-issuing department shall review the enterprise's compliance with medical device management laws and regulations, medical device production quality management standards, and the operation of the enterprise's quality management system, conduct on-site inspections if necessary, and decide whether to approve the renewal before the expiration of the medical device production license. decision.

After review, if the prescribed conditions are met, the extension will be granted, and the number of the extended medical device production license will remain unchanged. Those who do not meet the prescribed conditions shall be ordered to make corrections within a time limit; those who still fail to meet the prescribed conditions after rectification shall not be renewed, and the reasons shall be explained in writing.

If the approval time for the renewal of the license is within the validity period of the original license, the start date of the renewal shall be the day following the expiry date of the original license; if the approval time is not within the validity period of the original license, the start date of the renewal shall be the date on which the renewal of the license is approved.

Article 18 If a medical device manufacturing enterprise establishes a production site across provinces, autonomous regions or municipalities directly under the Central Government, it shall apply to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the newly established production site is located for a medical device production license.

Article 19 If a medical device production license is lost, an application shall be submitted to the original license-issuing department for reissuance. The original license-issuing department shall reissue the medical device production license in a timely manner, and the number and validity period of the reissued medical device production license shall be consistent with the original license.

Article 20 If the original or duplicate of the medical device production license is changed, the license-issuing department shall re-issue the original and duplicate of the changed medical device production license, and take back the original and duplicate of the original license; if only the duplicate is changed, the license-issuing department shall Re-issue the changed copy of the medical device production license, and take back the original copy of the license. The number and validity period of the changed medical device production license remain unchanged.

Article 21 Under any of the following circumstances, the original license-issuing department shall cancel the medical device production license according to law, and make an announcement:

(1) voluntarily apply for cancellation;

(2) The validity period has expired and it has not been renewed;

(3) The qualification as a market entity is terminated according to law;

(4) The medical device production license has been revoked or revoked according to law;

(5) Other circumstances under which the administrative license shall be cancelled according to laws and regulations.

Article 22 Those engaged in the production of Class I medical devices shall file with the department in charge of drug supervision and administration at the city divided into districts where they are located. After submitting the relevant materials stipulated in Article 10 of these Measures, the production filing shall be completed and the filing shall be obtained. Numbering. If the medical device recorder produces the first-class medical device by itself, it can also go through the production record when handling the product record.

The drug regulatory department shall, within 3 months from the date of production filing, conduct an on-site inspection of the submitted materials and the implementation of the medical device production quality management standard. Those that do not meet the requirements of the medical device production quality management standard shall be dealt with in accordance with the law and shall be ordered to make corrections within a time limit; if the safety and effectiveness of the products cannot be guaranteed, the filing shall be cancelled and an announcement shall be made to the public.

Article 23 If there is any change in the content of the production record of Class I medical devices, the materials related to the change as specified in Article 10 of these Measures shall be submitted to the original recordation department within 10 working days. On-site verification shall be carried out in accordance with the provisions of Article 22 of the Measures.

Article 24 No unit or individual may forge, alter, trade, lease or lend medical device production licenses.

Chapter III Production Quality Management

Article 25 Medical device registrants, filing parties, and entrusted manufacturers shall, in accordance with the requirements of the medical device production quality management standards, establish and improve a quality management system suitable for the medical devices produced and maintain its effective operation, and strictly follow the requirements of the quality management system for the production of medical devices. The registered or filed product technical requirements shall organize production to ensure that the medical devices that leave the factory meet the mandatory standards and the registered or filed product technical requirements.

Article 26 The legal representative and main responsible person of the medical device registrant and filing person shall be fully responsible for the quality and safety of the medical device produced by them.

Article 27 Medical device registrants, filing parties, and entrusted manufacturing enterprises shall be equipped with management representatives. The management representative is appointed by the legal representative or the main person in charge to perform the responsibilities of establishing, implementing and maintaining the effective operation of the quality management system.

Article 28 Medical device registrants, filing parties, and entrusted manufacturing enterprises shall carry out training on medical device laws, regulations, rules, standards and quality management, establish training systems, formulate training plans, strengthen assessments and keep training records .

Article 29 Medical device registrants, filers, and entrusted production enterprises shall reasonably allocate and use facilities and equipment according to the characteristics of the products they produce, technological processes and production environment requirements, strengthen the management of facilities and equipment, and maintain their effective operation.

Article 30 Medical device registrants and filers shall carry out conversion activities from design and development to production, and conduct sufficient verification and confirmation to ensure that the design and development output is suitable for production.

Article 31 Medical device registrants, filers, and entrusted manufacturers shall strengthen procurement management, establish a supplier review system, evaluate suppliers, and ensure that purchased products and services meet relevant regulations.

Medical device registrants, filers, and entrusted manufacturers should establish a raw material procurement acceptance record system to ensure that relevant records are true, accurate, complete and traceable.

Article 32 If the medical device registrant or filer entrusts the production, it shall evaluate the quality assurance ability and risk management ability of the entrusted party, and sign a quality agreement with the entrusted production quality agreement in accordance with the requirements of the State Drug Administration. As well as the entrustment agreement, supervise the entrusted party's performance of the obligations stipulated in the agreement.

The entrusted production enterprise shall organize production in accordance with the requirements of laws, regulations, rules, medical device production quality management standards, mandatory standards, product technical requirements, entrusted production quality agreement, etc. Supervision.

Article 33 Medical device registrants, filing parties, and entrusted manufacturing enterprises shall establish a record management system to ensure that the records are true, accurate, complete and traceable.

Encourage medical device registrants, filers, and entrusted production enterprises to adopt advanced technical means, establish an information management system, and strengthen the management of the production process.

Article 34 The medical device registrant and filing person shall be responsible for the release of products on the market, and establish the