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.