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【NMPA】Provisions for Supervision and Administration of Medical Device Manufacturing

2022-10-10 13:44:17 566

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.

Chapter IV Supervision and Inspection

Article 46 The drug regulatory department shall carry out supervision and inspection of manufacturing activities of the registrant, filing entity or contract manufacturer of medical devices by responsibilities according to law.

When necessary, the drug regulatory department may conduct extended inspection over other units or individuals that provide products or services for the manufacturing of medical devices.

Article 47 The drug regulatory department shall establish and improve a sound system for professional and specialized team of medical devices inspectors, and designate sufficient inspectors in accordance with the regulatory authority, industry scale and inspection task, etc., to guarantee the inspection needs effectively.

The inspectors shall be familiar with laws and regulations of medical devices, and have professional knowledge and inspection skills in terms of medical devices.

Article 48 In accordance with degree of risks of the products and enterprise, the drug regulatory department shall make graded management of the registrant, filing entity or contract manufacturer of medical devices as well as dynamic adjustment.

NMPA shall organize and formulate the list of products under key regulation. The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall determine the list of products under key regulation within the administrative areas in combination with the practical situation.

The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall organize and implement graded supervision and administration, in accordance with the list of products under key regulation and the management condition of manufacturing quality of medical devices, as well as in combination with medical device adverse events, product complaint reports and enterprise credit status, etc.

Article 49 The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall formulate annual supervision and inspection plan for manufacturing of medical devices, determine the key points of supervision and administration of medical devices, specify the inspection frequency and coverage, and make comprehensive use of multiple means such as supervision and inspection, key inspection, follow-up inspection, for-cause inspection and special inspection, etc. to strengthen supervision and administration.

For enterprises manufacturing varieties in the list of products under key regulation, inspection shall be made at least once a year.

Article 50 When organizing supervision and inspection, the drug regulatory department shall formulate an inspection plan, specify the inspection items and basis, record the on-site inspection condition truthfully, and notify the inspection results to the inspected enterprise in writing. If rectification is necessary, the rectification contents and period shall be specified.

When carrying out supervision and inspection, the drug regulatory department shall designate no less than two inspectors to implement the supervision and inspection. The law-enforcement personnel shall show law enforcement certificate to the inspected entity, while the other inspectors shall show their inspector certificate or other document or identity certification that can prove their identity.

Article 51 The drug regulatory department shall make key supervision and inspection on the registrant or filing entity of medical devices undertaking self-manufacturing regarding the following circumstances:

(1) enforcement of laws and regulations and the Good Manufacturing Practice for medical devices by the registrant or filing entity of medical devices;

(2) organizing manufacturing in accordance with mandatory standards and registered or filed technical specifications for the products; consistency of  the actual manufacturing with the contents of medical device registration and filing, and medical device manufacturing licensing and filing, etc.;

(3) condition of continuous compliance and effectiveness of the quality management system;

(4) the legal representative, person in charge of the enterprise, the management representative and other personnel’s understanding and familiarization condition with medical device related laws and regulations;

(5) the management representative’s performance of duties;

(6) changes in the legal representative, person in charge of the enterprise, the management representative, quality testing institution or full-time personnel, manufacturing premises, environmental conditions and key manufacturing testing equipment, etc.;

(7) corrective and preventive actions for problems from user feedback or discovered during internal audit of the enterprise, etc.;

(8) rectification implementation condition of problems discovered from sample testing of the enterprise’s products, supervision and inspection, complaint report, etc.;

(9) internal audit, management review, change control, annual self-inspection report and other conditions;

(10) other contents ought to be inspected with emphasis.

Article 52 The drug regulatory departments shall make key supervision and inspection on the registrant or filing entity of medical devices making entrusted manufacturing regarding the following circumstances:

(1) enforcement of laws and regulations and the Good Manufacturing Practice for medical devices by the registrant or filing entity of medical devices;

(2) whether the quality management system is continuously compliant and effective;

(3) the management representative’s performance of duties;

(4) condition of organizing manufacturing according to the mandatory standards and registered or filed technical specifications for the products;

(5) corrective and preventive actions for problems from user feedback or discovered during internal audit of the enterprise, etc.;

(6) internal audit, management review, change control, annual self-inspection report and other conditions;

(7) condition of carrying out adverse events monitoring and reevaluation, and collection and evaluation of information on product safety risks;

(8) marketing release conditions of the products;

(9) supervision of the contract manufacturer, performance of the entrustment manufacturing quality agreement, design conversion and change control of the products entrusted for manufacturing, and manufacturing and release of the products entrusted for manufacturing, etc.;

(10) other contents ought to be inspected with emphasis.

When necessary, inspection shall be carried out toward the contract manufacturer.

Article 53 The drug regulatory departments shall make key supervision and inspection on the contract manufacturer of medical devices regarding the following circumstances:

(1) consistency of the actually manufactured products and the contents of medical device registration and filing, and medical device manufacturing licensing and filing, etc.;

(2) enforcement of laws and regulations and the Good Manufacturing Practice for medical devices by the contract manufacturer of medical devices;

(3) the legal representative, person in charge of the enterprise, the management representative and other personnel’s understanding and familiarization with medical device-related laws and regulations;

(4) changes in the legal representative, person in charge of the enterprise, the management representative, quality testing institution or full-time personnel, manufacturing premises, environmental conditions and key manufacturing testing equipment, etc.;

(5) manufacturing and release conditions of the products;

(6) rectification implementation condition of problems discovered from sample testing of the enterprise’s products, supervision and inspection, complaint report, etc.;

(7) internal audit, management review, annual self-inspection report and other conditions;

(8) other contents ought to be inspected with emphasis.

When necessary, inspection shall be carried out toward the registrant and filing entity of the medical devices.

Article 54 If the drug regulatory departments find that there might be serious quality safety risks from adverse events monitoring, sample testing and compliant reporting, etc., they shall carry out for-cause inspection. In principle, the for-cause inspection shall be performed without advance notice.

Article 55 The drug regulatory department shall carry out follow-up inspection of the enterprise’s rectification condition.

Follow-up inspection could make written review of the rectification report submitted by the enterprise, or make on-site review of the enterprise’s rectification of problems, implementation of responsibilities, and corrective and preventive measures, etc.

Article 56 If the medical device registrant and the contract manufacturer are not in the same province, autonomous region or municipality directly under the central government, the drug regulatory department of the province, autonomous region, or municipality directly under the central government of the place where the registrant of medical devices is located shall be responsible for carrying out supervision and inspection of the registrant’s performance of its legal duties such as operation of quality management system, adverse events monitoring and product recall, etc., and if relevant conditions of the contract manufacturer, the drug regulatory department of the place where the contract manufacturer is located shall make cooperation.

The drug regulatory department of the province, autonomous region, or municipality directly under the central government of the place where the contract manufacturer is located shall be responsible for carrying out supervision and inspection of the contract manufacturer’s manufacturing activities, and if involving relevant conditions of the registrant, the drug regulatory department of the place where the registrant is located shall carry out supervision and inspection on the registrant.

The drug regulatory department of the province, autonomous region, or municipality directly under the central government of the place where the registrant or contract manufacturer of the medical devices is located shall implement local supervision and administration responsibility, establish coordinated supervision and administration mechanism to strengthen communication on regulatory information and realize effective cohesion.

Article 57 If the registrant and the contract manufacturer of medical devices are not in the same province, autonomous region or municipality directly under the central government, and the drug regulatory department of the province, autonomous region, or municipality directly under the central government of the place where the registrant or the contract manufacturer is located needs to carry out cross-region inspection, it could also make inspection by means of joint inspection and entrusted inspection, etc.

Article 58 If it is found in cross-region inspection that there is defect with the enterprise quality management system, the drug regulatory department of the province, autonomous region, or municipality directly under the central government of the place where the registrant or the contract manufacturer of medical devices is located shall, in accordance with their respective duties, urge relevant enterprises to make prompt rectification in place as required, and inform the inspection and rectification conditions to related drug regulatory department in a timely manner.

If related problems found in supervision and inspection of the contract manufacturer involve the registrant, the drug regulatory department of the place where the registrant is located shall be informed; if it is found that there might be quality safety risks of the medical devices, risk control measures shall be taken immediately, and related information shall be informed to the drug regulatory department of the place where the registrant is located. Upon receipt of the notification, the drug regulatory department of the place where the registrant is located shall make analysis and judgment immediately, and take corresponding risk control measures.

If related problems found in supervision and inspection of the registrant involve the contract manufacturer, notification shall be made to the drug regulatory department of the place where the contract manufacturer is located, or inspection shall be made in collocation with or entrusted to the drug regulatory department of the place where the contract manufacturer is located.

Article 59 If suspicious illegal acts is found in cross-region inspection, the drug regulatory department of the province, autonomous region, or municipality directly under the central government of the place where the registrant or the contract manufacturer of medical devices is located shall make investigation and handling according to their own duties. The handling condition of the illegal acts shall be promptly informed to the related drug regulatory department.

If it needs to make investigation and obtain evidences across the region, joint investigation can be made together with related drug regulatory department at the same level, or a letter of assistance in investigation shall be issued to ask related drug regulatory department at the same level for assistance in investigation and obtaining evidences.

Article 60 If the filing entity and the contract manufacturer of Class I medical devices are not in the same city divided into districts, and when it is necessary to carry out cross-regional supervision and inspection as well as investigation and obtaining of evidences by duties according to law, it shall be executed in accordance with Article 56 to Article 59 of these Provisions.

Article 61 The registrant or filing entity of imported medical devices shall designate the domestic enterprise legal person as the agent, who shall assist the registrant or filing entity to fulfill the obligations prescribed in the Regulations on Supervision and Administration of Medical Devices and these Provisions.

Article 62 Manufacturing of imported medical devices shall conform to relevant requirements for manufacturing of medical devices in China, and accept overseas inspection organized by NMPA. The agent shall be responsible for work related to coordinating and cooperating with overseas inspection.

If the registrant, filing entity or agent of imported medical devices refuses, hinders, delays and evades overseas inspection organized by NMPA, which causes failure in carrying out the inspection, making it unable to confirm effective operation of the quality management system, which belongs to the circumstance that there is evidence proving causing potential harm to human health, NMPA may handle in accordance with provisions in Article 72(2) of the Regulations on Supervision and Administration of Medical Devices.

Article 63 When carrying out on-site inspection, the drug regulatory department can make sample testing as needed.

Article 64 With respect to medical devices that have caused injury to human body or proved to cause potential harm to human health, the drug regulatory department may take emergency control measures to suspend their manufacturing, import, distribution and use, and announce safety warnings.

If it is found in supervision and inspection that the manufacturing activities are in serious violation of the Good Manufacturing Practice for medical devices, thus being unable to ensure safety and effectiveness of the products, and might cause potential harm to human health, it shall be handled as stipulated in the preceding paragraph.

Article 65 The drug regulatory department shall regularly organize risk conference or consultation, to make analysis and evaluation of the quality and safety risks of the medical devices within the jurisdiction area, and take corresponding risk control measures in a timely manner.

Article 66 If the registrant, filing entity or contract manufacturer of medical devices fails to take effective measures for removing existing quality and safety risks of the medical devices, the drug regulatory department may make responsibility interview with the legal representative or the person in charge of the enterprise of the registrant, filing entity or contract manufacturer of medical devices. If cross-region entrusted manufacturing is involved, the interview condition shall be informed to related drug regulatory departments.

Article 67 The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall establish and timely update the credit files of the registrant or the contract manufacturer of Class II and Class III medical devices within the jurisdiction area, the department in charge of drug supervision and administration at the level of a city divided into districts shall establish and promptly update the credit files of Class I medical device filing entity or the contract manufacturer within the jurisdiction area according to its duties.

The credit file shall include manufacturing licensing filing and manufactured product variety, entrusted manufacturing, supervision and inspection results, investigation of illegal acts, sample testing of quality, records of dishonest behaviors and complaint report, etc.

For registrant, filing entity or contract manufacturer of medical devices with bad credit records, the drug regulatory department shall increase supervision and inspection frequency, and impose heavier punishment on dishonest behaviors.

Article 68 The drug regulatory department shall record the varieties of the products manufactured by the enterprise in the credit file.

If the contract manufacturer increases the manufacturing of Class II and Class III medical devices, and is not in the same province, autonomous region or municipality directly under the central government with the registrant, or increases the manufacturing of Class I medical devices, and is not in the same city divided into districts with the filing entity, the drug regulatory department of the place where the contract manufacturer is located shall also inform related conditions to the drug regulatory departments of the places where the registrant and the filing entity are located.

Article 69 The drug regulatory department shall make known to the public contact information for accepting complaints and reports. Upon receipt of reports, the drug regulatory department shall make verification, handling and reply in a timely manner. If it is deemed authentic upon verification, the reporters shall be rewarded in accordance with relevant regulations.

Article 70 If suspected illegal acts are found during the supervision and inspection, the drug regulatory departments shall promptly collect and solidify the evidences, and open a case for investigation and punishment according to law; if a crime is suspected, the violators shall be handed over to the public security organ for handling in a timely manner.

Article 71 The drug regulatory departments and their staff shall keep the business secrets known from the investigation and inspection confidential.

Article 72 During the supervision and inspection, the drug regulatory departments and their staff shall enforce the law in a strict, procedure-based, impartial and non-abusive manner, strictly enforce the discipline of clean government, and shall not ask for or accept property, seek for other interests, or hinder normal manufacturing activities of the enterprises.

Chapter V Legal Liability

Article 73 For illegal acts in manufacturing of medical devices, if there have been provisions prescribed in the Regulations on Supervision and Administration of Medical Devices and other laws and regulations, such provisions shall prevail.

Article 74 In one of the following circumstances, punishment shall be imposed in accordance with provisions in Article 81 of the Regulations on Supervision and Administration of Medical Devices:

(I) manufacturing Class II and Class III medical devices beyond the manufacturing scope stated in the Medical Device Manufacturing License;

(2) manufacturing Class II or Class III medical devices in manufacturing premises without permission;

(3) upon expiration of valid term of the Medical Device Manufacturing License, the manufacturer continues to engage in manufacturing of Class II and Class III medical devices without handling renewal formalities according to law;

(4) the medical device manufacturer increases varieties of manufactured products without handling licensing change though it ought to do so.

Article 75 If failing to handle Class I medical device manufacturing or filing change as stipulated in these Provisions, it shall be handled in accordance with provisions in Article 84 of the Regulations on Supervision and Administration of Medical Devices.

Article 76 For violation of the Good Manufacturing Practice for medical devices, failure in establishing a quality management system and maintaining its effective operation, the drug regulatory department shall order rectification within prescribed time limit according to its duties; if the safety and effectiveness of medical device products are affected, punishment shall be imposed in accordance with provisions in Article 86 of the Regulations on Supervision and Administration of Medical Devices.

Article 77 For violation of provisions in Article 15(2) and Article 42(3) of these Provisions, where, the manufacturing conditions are changed, and the product safety and effectiveness might be affected, but the manufacturer performs manufacturing without making report as stipulated, it shall be punished in accordance with provisions in Article 88 of the Regulations on Supervision and Administration for Medical Devices.

Article 78 In one of the following circumstances, the drug regulatory department shall give warning according to its duties, and impose a fine of more than 10,000 yuan and less than 50,000 yuan:

(1) the medical device manufacturer fails to report the variety and related information of the manufactured products to the drug regulatory department in accordance with provisions in Article 42(2) of these Provisions;

(2) the medical device manufacturer has suspended manufacturing for above one year and there are no similar products under manufacturing, and when starting manufacturing again, it fails to make necessary verification and validation, and report to the drug regulatory department of the place where it is located.

Article 79 In one of the following circumstances, the drug regulatory department shall order rectification within prescribed time limit according to its duties; for refusal to rectification, a fine of not less than 10,000 yuan and not more than 50,000 yuan shall be imposed; for severe circumstances, a fine of not less than 50,000 yuan and not more than 100,000 yuan shall be imposed:

(1) failing to handle change of registration items in the Medical Device Manufacturing License in accordance with provisions in Article 16 of these Provisions;

(2) failing to carry out code assignment, data uploading and maintenance and updating, etc. in accordance with relevant requirements of the state for implementing UDI of medical devices.

Article 80 Officers from the drug regulatory department who abuse their powers, neglect their duties, or engage in malpractice for personal gains violating provisions of these Provisions, shall be given sanctions in accordance with the law.

Chapter VI Supplementary Provisions

Article 81 These Provisions shall be effective as of May 1, 2022. Upon effectiveness of these Provisions, the Provisions for the Supervision and Administration of Medical Device Production issued by Decree No. 7 of the former China Food and Drug Administration on July 30, 2014 shall be repealed.

 

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.