Provisions for Supervision and Administration of Medical Device Manufacturing

(Promulgated by Decree No. 53 of the State Administration for Market Regulation on March 10, 2022, these Provisions shall be effective as of May 1, 2022.)

Chapter I General Provisions

Article 1 These Provisions are formulated in accordance with the Regulations on Supervision and Administration of Medical Devices for the purpose of strengthening supervision and administration of medical device manufacturing, regulating the manufacturing activities of medical devices, and ensuring the safety and effectiveness of medical devices.

Article 2 These Provisions shall apply to medical device manufacturing activities and its supervision and administration within the territory of the People’s Republic of China.

Article 3 To engage in manufacturing activities of medical devices, an entity shall comply with laws, regulations, provisions, mandatory standards and the Good Manufacturing Practice for medical devices, and guarantee that information on the whole medical device manufacturing process is authentic, accurate, complete and traceable.

The registrant and filing entity of medical devices are responsible for the safety and effectiveness of marketed medical devices.

Article 4 Medical device manufacturing is subject to classified management in accordance with their degree of risks.

To engage in manufacturing of Class II and Class III medical devices, an entity shall obtain approval from the drug regulatory department of the local province, autonomous region, or municipality directly under the central government, and acquire Medical Device Manufacturing License according to law; to engage in manufacturing of Class I medical devices, an entity shall handle medical device manufacturing filing formalities at the local department in charge of drug supervision and administration at the level of a city divided into districts.

Article 5 The National Medical Products Administration (NMPA) shall be responsible for the supervision and administration of medical device manufacturing nationwide.

The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall be responsible for supervision and administration of Class II and Class III medical device manufacturing within their administrative areas, be responsible for the supervision and administration of Class I medical device manufacturing within their administrative areas in accordance with their duties according to law, and strengthen guidance for the supervision and administration of Class I medical device manufacturing within their administrative areas.

The department in charge of drug supervision and administration at the level of a city divided into districts shall be responsible for the supervision and administration of Class I medical device manufacturing within their administrative areas in accordance with their duties according to law.

Article 6 The drug regulatory department shall set or designate professional technical institutions for review, inspection, testing, monitoring and reevaluation, etc. of medical devices according to law, to assume relevant technical work in accordance with division of responsibilities, and to provide technical support for supervision and administration of medical device manufacturing.

The Center for Food and Drug Inspection of NMPA shall organize and draft medical device inspection system specification and technical documents, assume significant for-cause inspection and overseas inspection, etc., and conduct instruction and evaluation of the quality management system of medical device inspection institutions of the province, autonomous region, or municipality directly under the central government.

Article 7 NMPA shall strengthen the construction of information technology regarding supervision and administration of medical device manufacturing, and improve the online government services.

The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall be responsible for the construction and management of information technology for supervision and administration of medical device manufacturing within the administrative areas, and the coordination and promotion of information sharing on supervision and administration of medical device manufacturing as required by NMPA.

Article 8 The drug regulatory department shall promptly disclose information on manufacturing licenses, filing, supervision and inspection and administrative penalty, etc. of medical devices according to law, to facilitate public inquiry and accept social supervision.

Chapter II Manufacturing Licensing and Filing Management

Article 9 To engage in manufacturing activities of medical devices, the following conditions shall be met:

(1) having manufacturing premises, environmental conditions, manufacturing equipment, and professional technicians required for the medical devices manufactured;

(2) having the institutions, full-time testing personnel and equipment capable of meeting the quality testing requirements for the medical devices manufactured;

(3) having the management systems to ensure the quality of the medical devices;

(4) having the after-sales service capability commensurate with the medical devices manufactured;

(5) meeting the requirements specified in the documents on product development and manufacturing process.

Article 10 An enterprise to be engaged in the manufacturing of Class II or III medical devices shall apply for a manufacturing license to the drug regulatory department of the province, autonomous region, or municipality directly under the central government where it is located, and shall submit the following materials:

(1) copies of registration certificate and technical specifications for the medical devices manufactured;

(2) copies of identification proof of the legal representative (person in charge of the enterprise);

(3) copies of related materials such as identities, academic degrees and professional titles of the persons in charge of manufacturing, quality and technology;

(4) the list of academic degrees and professional titles of personnel on manufacturing management and quality testing positions;

(5) copies of relevant documents of the manufacturing premises, and if there are special requirements for manufacturing environment, copies of relevant documents of the facilities and environment shall also be submitted;

(6) the list of main manufacturing equipment and testing equipment;

(7) the quality manual and list of procedure documents;

(8) the flow chart of manufacturing process;

(9) relevant materials proving the after-sales service capability;

(10) the authorization document of the handling personnel.

The applicant shall ensure the legitimacy, authenticity, accuracy, integrity and traceability of the materials submitted.

The applicant does not need to submit relevant materials that can be inspected online.

Article 11 Upon receipt of application, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall handle respectively according to the following circumstances:

(1) If the subject matter of the application falls within the scope of this administrative authority, and the application dossiers are complete and conform to statutory form, then the application shall be accepted;

(2) If the application dossiers contain errors that can be corrected on site, the applicant shall be allowed to make corrections on site;

(3) If the application dossiers are not complete or do not conform to statutory form, the applicant shall be notified of all contents ought to be supplemented and corrected on site or within 5 working days one-off. If no notification is made within the prescribed time limit, the application shall be deemed to have been accepted upon receipt of the application dossiers;

(4) If the subject matter of the application does not fall within the scope of this administrative authority, a decision of not accepting the application shall be made immediately, and the applicant shall be notified of applying to relevant administrative authority.

For acceptance or non-acceptance of the application for Medical Device Manufacturing License, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall issue an acceptance or non-acceptance notice fixed with special seal of the administrative authority and indicated with date.

Article 12 For matters of which a public hearing shall be held for implementation of administrative licensing as stipulated by laws, regulations and provisions, or for other important administrative licensing matters involving public interests for which a public hearing needs to be held as deemed by the drug regulatory department, the drug regulatory department shall make an announcement to the public and hold a public hearing. If the application for Medical Device Manufacturing License involves vital interests between the applicant and others directly, then before making a decision on administrative licensing, the drug regulatory department shall notify the applicant and the stakeholders that they are entitled to request for a public hearing.

Article 13 The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall examine the application dossiers, and conduct inspection in compliance with the requirements of the Good Manufacturing Practice for medical devices formulated by NMPA, and make decisions within 20 working days from the date of acceptance. The on-site inspection shall be combined with inspection of the product registration system, to avoid repeated inspection. If rectification is necessary, the rectification time shall not be included in the review time.

If the applicant meets the specified conditions, its application shall be approved according to law, and the Medical Device Manufacturing License shall be issued within 10 working days; if it does not meet the specified conditions, its application shall not be approved and the reasons shall be given in writing. In the meantime, the applicant shall be notified that it is entitled to apply for administrative reconsideration or administrative litigation according to law.

Article 14 The Medical Device Manufacturing License consists of the original and duplicate, with a valid term of 5 years. Both the original and the duplicate shall be indicated with the license number, enterprise name, unified social credit identifier, legal representative (person in charge of the enterprise), domicile, manufacturing address, manufacturing scope, license issuing department, date of issuance, and valid term. The duplicate shall record changes in items stated in the original copy or major modification of the production line and other conditions. Items such as the enterprise name, unified social credit identifier, legal representative (person in charge of the enterprise) and domicile, etc. shall be consistent with those stated in the Business License.

The Medical Device Manufacturing License applies the uniform format made by NMPA, and shall be printed by the drug regulatory department of the province, autonomous region, or municipality directly under the central government.

The electronic Medical Device Manufacturing License shall be equally authentic with the paper license.

Article 15 In case of changes in manufacturing address or increase of manufacturing scope, the applicant shall apply to the former license issuing department for changes in Medical Device Manufacturing License, and submit relevant materials of the changes involved in Article 10 of these Provisions. The former license issuing department shall conduct review and carry out on-site inspection as stipulated in Article 13 of these Provisions.

In case of changes in manufacturing conditions due to modification of workshop or production line, which may affect the safety and effectiveness of the medical devices, the applicant shall report to the former license issuing department. For changes in licensing items, the applicant shall handle relevant licensing change formalities as stipulated.

Article 16 In case of changes in enterprise name, legal representative (person in charge of the enterprise), domicile or literal change in manufacturing address, and reduction in manufacturing scope, the applicant shall apply to the former license issuing department for changes of registration items within 30 working days upon change, and submit relevant materials. The former license issuing department shall complete change of registration items within 5 working days.

Article 17 If the Medical Device Manufacturing License needs to be renewed upon expiration of the valid term, the applicant shall apply for renewal within 30 to 90 working days before expiration of the valid term. If an application for renewal fails to be made within prescribed time limit, such application shall no longer be accepted.

The former license issuing department shall make review in combination with the enterprise’s compliance with laws and regulations on administration of medical devices, the Good Manufacturing Practice for Medical Devices, and operation condition of the enterprise’s quality management system, and carry out on-site inspection if necessary, and then make a decision on whether granting renewal or not before expiration of valid term of the Medical Device Manufacturing License.

If specified conditions are met upon review, renewal shall be granted, and the number of the renewed Medical Device Manufacturing License shall remain the same. If specified conditions are not met, rectification within a prescribed time limit shall be ordered; if specified conditions are still not met upon rectification, renewal shall not be granted, and the reasons shall be given in writing.

If the license renewal is approved within the valid term of the former license, then the starting time of the renewal shall be the day following the expiry date of the former license; if the approval time is not within the valid term of the former license, then starting date of the renewal shall be the date approved for license renewal.

Article 18 If a medical device manufacturer establishes the manufacturing premises across the province, autonomous region or municipality 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 of the place where the manufacturing premises is located for Medical Device Manufacturing License.

Article 19 If the Medical Device Manufacturing License is lost, the applicant shall apply to the former license issuing department for re-issuance. The former license issuing department shall promptly re-issue the Medical Device Manufacturing License, and the number and valid term of the re-issued Medical Device Manufacturing License shall be consistent with those of the former license.

Article 20 For changes of the original copy and duplicate of the Medical Device manufacturing License, the license issuing department shall re-issue the original copy and duplicate of the Medical Device Manufacturing License after change, and withdraw the original copy and duplicate of the former license; for changes of the duplicate only, the license issuing department shall re-issue the duplicate of the Medical Device Manufacturing License after change, and withdraw the duplicate of the former license. The number and valid term of the Medical Device Manufacturing License after change remain the same.

Article 21 In one of the following circumstances, the former license issuing department shall cancel the Medical Device Manufacturing License according to law, and make an announcement:

(1) the cancellation is applied voluntarily;

(2) the License is not renewed upon expiration of the valid term;

(3) the eligibility as a market entity is terminated according to law;

(4) the Medical Device Manufacturing License is revoked or withdrawn according to law;

(5) other circumstances where administrative licensing shall be canceled as stipulated by laws and regulations.

Article 22 An enterprise to be engaged in manufacturing Class I medical devices shall file the matter with the department in charge of drug supervision and administration at the level of a city divided into districts, and submit the related materials as prescribed in Article 10 of these Provisions to complete the manufacturing filing, and obtain the filing number. Where the medical device filing entities manufacture Class I medical devices by themselves, they may handle the manufacturing filing together with the product filing.

Within 3 months upon manufacturing filing, the drug regulatory department shall carry out on-site inspection of the submitted materials and the implementation of the Good Manufacturing Practice for medical devices. If non-conforming to the Good Manufacturing Practice for medical devices, it shall be treated according to law and rectification shall be ordered to be made within a prescribed time limit; if the product safety and effectiveness cannot be guaranteed, the filing shall be canceled, and an announcement shall be made public.

Article 23 In case of changes in manufacturing filing contents of Class I medical devices, the applicant shall submit materials related with such changes as stipulated in Article 10 of these Provisions to the former filing department within 10 working days, and if necessary, the drug regulatory department may carry out on-site inspection as stipulated in Article 22 of these Provisions.

Article 24 No entity or individual is allowed to falsify, alter, trade in, rent or lend out the Medical Device Manufacturing License.

Chapter III Manufacturing Quality Management

Article 25 The registrant, filing entity, and contract manufacturer of medical devices shall, in compliance with the requirements of the Good Manufacturing Practice for medical devices, establish and improve the quality management system commensurate with the medical devices manufactured and maintain its effective operation, organize manufacturing in strict accordance with the registered or filed technical specifications for the products, and ensure that the medical devices released from the factory meet the mandatory standards and registered or filed technical specifications for the products.

Article 26 The legal representative and principal responsible person of the registrant or filing entity of medical devices shall assume full responsibility for quality and safety of the medical devices manufactured.

Article 27 The registrant, filing entity or contract manufacturer of medical devices shall designate a management representative. The management representative is entrusted by the legal representative or principal responsible person with establishing, implementing and maintaining effective operation of the quality management system, etc.

Article 28 The registrant, filing entity or contract manufacturer of medical devices shall carry out training in aspects such as laws, regulations, provisions, standards and quality management, etc. of medical devices, establish training system, formulate training plan, strengthen the assessment and keep proper training records.

Article 29 The registrant, filing entity or contract manufacturer of medical devices shall, based on the characteristics, technical process and requirements for manufacturing environment of the manufactured products, rationally equip and use of the facilities and equipment, strengthen the management of the facilities and equipment, and maintain their effective operation.

Article 30 The registrant or filing entity of medical devices shall carry out transition activities from design and development to manufacturing, and make full verification and validation, so as to ensure that the output of design and development is applicable to the manufacturing.

Article 31 The registrant, filing entity or contract manufacturer of medical devices shall enhance purchase management, establish suppliers audit system, and evaluate the suppliers, to ensure that the purchased products and services conform to relevant regulations and requirements.

The registrant, filing entity or contract manufacturer of medical devices shall establish procedures for purchasing, accepting and recording raw materials, to ensure authenticity, accuracy, integrity and traceability of related records.

Article 32 If the registrant or filing entity of medical devices entrusts manufacturing to others, they shall evaluate the quality assurance capability and risk management capability of the entrusted party, sign Quality Agreement and Entrustment Agreement with the entrusted party in accordance with the requirements of Guidelines for Quality Agreement on Entrusted Manufacturing formulated by NMPA, and supervise the entrusted party in performing its obligations agreed in related agreements.

The contract manufacturer shall organize manufacturing in accordance with laws, regulations and provisions, the Good Manufacturing Practice for medical devices, mandatory standards, technical specifications for the products and entrusted manufacturing quality agreement, etc., and shall be responsible for the manufacturing acts and accept the supervision of the registrant and filing entity of the medical devices.

Article 33 The registrant, filing entity or contract manufacturer of medical devices shall establish record management procedures, to ensure the authenticity, accuracy, integrity and traceability of the records.

The registrant, filing entity or contract manufacturer of medical devices are encouraged to establish information management system by advanced technical means, to strengthen management of the manufacturing process.

Article 34 The registrant or filing entity of medical devices shall be responsible for marketing release of the products, establishing procedures for marketing release of products, specifying the release criteria and conditions, and reviewing the manufacturing process records and quality testing reports of the medical devices, and if conforming to criteria and conditions, the medical products can enter the market only upon signature of the authorized release personnel. For entrusted manufacturing, the registrant or filing entity of medical devices shall also review the manufacturing release document from the contract manufacturer.

The contract manufacturer shall establish procedures for manufacturing release, specify the criteria and conditions for manufacturing release, and ensure that only those conforming to the criteria and conditions could be released from the factory.

Those not conforming to laws, regulations, provisions, mandatory standards and registered or filed technical specifications for the products shall not be released from the factory or be marketed.

Article 35 The registrant or filing entity of medical devices shall establish and implement the procedures for tracing products, to guarantee the traceability of the products. The contract manufacturer shall assist with the registrant and the filing entity in tracing the products.

Article 36 The registrant, filing entity or contract manufacturer of medical devices shall, in accordance with relevant requirements of the state for implementing Unique Device Identification (UDI) of medical devices, carry out code assignment, data uploading, maintenance and updating, to guarantee the authenticity, accuracy, integrity and traceability of the information.

Article 37 The registrant, filing entity or contract manufacturer of medical devices shall establish procedures for corrective actions, determine the cause for problems and take effective measures, to prevent recurrence of related problems.

The registrant, filing entity or contract manufacturer of medical devices shall establish procedures for preventive actions, ascertain the cause for potential problems and take effective measures, to prevent occurrence of problems.

Article 38 The registrant or filing entity of medical devices shall, in accordance with requirements of the Good Manufacturing Practice for medical devices, identify and control changes in raw materials, manufacturing process, etc. that might affect the safety and effectiveness of the products. If it is necessary to make registration change or filing change, the applicant shall handle relevant formalities according to stipulations on administration of registration and filing.

Article 39 Upon implementation of new mandatory standards, the registrant or filing entity of medical devices shall identify the differences between the technical specifications and the mandatory standards of the products. If it is necessary to make registration change or filing change, they shall handle relevant formalities according to stipulations on administration of registration and filing.

Article 40 The registrant, filing entity or contract manufacturers of medical devices shall perform their responsibility for monitoring adverse events in accordance with relevant regulations on monitoring adverse events of medical devices, carry out monitoring of adverse events, and report their investigation, analysis, reevaluation, product risk control results, etc. to the medical devices adverse event monitoring technical institutions.

Article 41 Where a medical device registrant or filing entity finds that medical devices do not meet the mandatory standards or the registered or filed technical specifications for the products, or have other defects, it shall immediately stop manufacturing the devices, notify relevant distributors, using units and consumers to stop distributing or using, recall the medical devices already in the market, take remedial measures or destroy them, record the relevant situations, release the relevant information, and report to the drug regulatory department and the competent health department how it has recalled and handled the medical devices.

The contract manufacturer shall perform its responsibilities in accordance with relevant stipulations on recall of medical devices, and assist with the registrant or filing entity of medical devices in recalling the manufactured medical devices.

Article 42 The medical device manufacturer shall report the variety of the manufactured products to the drug regulatory department.

To increase variety of the manufactured products, the manufacturer shall report to the former manufacturing licensing or manufacturing filing department, and if entrusted manufacturing is involved, it shall also provide information on the entrusting party, the products entrusted for manufacturing, and the entrusting term, etc.

If the increased manufactured products involve changes in manufacturing conditions, which might affect the safety and effectiveness of the products, the medical device manufacturer shall report to the former manufacturing licensing department 30 working days before increasing the manufactured products, and the former manufacturing licensing department shall promptly carry out on-site inspection. For changes in licensing items, the applicant shall handle relevant licensing change formalities as stipulated.

Article 43 If a medical device manufacturer has suspended manufacturing for more than one year and there are no similar products under manufacturing, when starting manufacturing again, it shall make necessary verification and validation, and report to the drug regulatory department in writing. If the quality and safety might be affected, the drug regulatory department may also organize inspection as needed.

Article 44 Where changes occur in the manufacturing conditions of the registrant, filing entity, and contract manufacturer of medical devices, so that the conditions cease to meet the requirements of the quality management system for medical devices, measures for rectification shall be taken immediately; where the safety and effectiveness of the medical devices may possibly be affected, the enterprise shall immediately stop manufacturing and report the matter to the former department that issued the Manufacturing License or accepted for filing.

The contract manufacturer shall promptly inform the medical devices registrant or filing entity of the changes.

Article 45 The registrant, filing entity, and contract manufacturer of medical devices shall conduct annual self-inspection of the operation of its quality management system, and submit self-inspection reports to the drug regulatory department of the place where it is located before the next March 31. The registrant or filing entity of imported medical devices shall entrust its agent to submit self-inspection report to the drug regulatory department of the province, autonomous region, or municipality directly under the central government of the place where the agent is located.