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

Article 2 Engaging in medical device production activities and their supervision and management within the territory of the People's Republic of China shall comply with these Measures.

Article 3 Engaging in medical device production activities shall comply with laws, regulations, rules, mandatory standards and medical device production quality management norms to ensure that the information in the whole process of medical device production is true, accurate, complete and traceable.

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

Article 4 According to the risk degree of medical devices, medical device production shall be classified and managed.

Engaging in the production of Class II and III medical devices shall obtain a medical device production license in accordance with the law with the approval of the drug administration department of the province, autonomous region or municipality directly under the Central Government; Engaging in the production of Class I medical devices shall handle the filing of medical device production with the department responsible for drug supervision and administration at the districted municipal level where the region is located.

Article 5 The State Medical Products Administration shall be responsible for the national supervision and management of medical device production.

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

Article 6 Professional and technical institutions such as medical device review, inspection, inspection, monitoring and evaluation established or designated by the drug regulatory department shall undertake relevant technical work in accordance with the division of duties and provide technical support for the supervision and management of medical device production.

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

The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the informatization construction and management of medical device production supervision and management in their respective administrative regions, and coordinates and promotes the sharing of medical device production supervision and management information in accordance with the requirements of the State Medical Products Administration.

Article 8 The drug regulatory department shall promptly disclose information such as medical device production licenses, filings, supervision and inspection, and administrative penalties in accordance with the law to facilitate public inquiry and acceptance of social supervision.

Article 9 Engaging in medical device production activities shall meet the following conditions:

(1) There shall be production sites, environmental conditions, production equipment, and professional and technical personnel suitable for the medical devices being produced;

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

(3) There is a management system to ensure the quality of medical devices;

(4) There is an after-sales service capability suitable for the medical devices produced;

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

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

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

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

(3) A copy of the identity, academic qualifications and professional title of the person in charge of production, quality and technology;

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

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

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

(7) Catalogue of quality manuals and procedure documents;

(8) Production process flow chart;

(9) Relevant materials proving after-sales service capabilities;

(10) Authorization documents of the handler.

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

If the relevant materials can be verified through the network, the applicant does not need to provide them.

Article 11 After receiving the application, the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall handle the application according to the following circumstances:

(1) If the application matters fall within the scope of the administrative organ's authority, and the application materials are complete and in accordance with the statutory form, the application shall be accepted;

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

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

(4) If the application is not within the scope of the administrative organ's authority in accordance with the law, it shall immediately make a decision not to accept it and inform the applicant to apply to the relevant administrative organ.

If the provincial, autonomous region, or municipal drug administration department accepts or refuses to accept the application for a medical device production license, it shall issue a notice of acceptance or rejection stamped with the special seal of the administrative organ and the date.

Article 12 The drug administration department shall announce to the public and hold a hearing on matters that laws, regulations, and rules stipulate that the implementation of administrative licensing shall be heard, or other major administrative licensing matters involving public interest that the drug administration department deems necessary to be heard. If the application for a medical device production license directly involves a major interest relationship between the applicant and others, the drug administration department shall inform the applicant and interested parties of their right to request a hearing before making an administrative licensing decision.

Article 13 The drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall review the application materials, verify them in accordance with the requirements of the medical device production quality management standards formulated by the State Medical Products Administration, and make a decision within 20 working days from the date of acceptance of the application. On-site verification can be combined with product registration system verification to avoid duplicate verification. If rectification is required, the rectification time shall not be included in the review time limit.

If the prescribed conditions are met, a written decision to grant the license shall be made in accordance with the law, and the "Medical Device Production License" shall be issued within 10 working days; if the specified conditions are not met, a written decision shall be made to deny the permit, explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.

Article 14 The medical device production license is divided into original and copy, and is valid for 5 years. The original and copy indicate the license number, enterprise name, unified social credit code, legal representative (person in charge of the enterprise), domicile, production address, production scope, issuing department, date of issuance and validity period. The copy records the changes in matters and major transformations of the workshop or production line in the original license. The enterprise name, unified social credit code, legal representative (person in charge of the enterprise), domicile and other items shall be consistent with the relevant content specified in the business license

The medical device production license shall be uniformly issued by the State Medical Products Administration and issued by the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government.

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

Article 15 If the production address is changed or the scope of production is increased, it shall apply to the original issuing department for a change in the production license of medical devices, and submit relevant materials related to the changes in the provisions of Article 10 of these Measures.

If the workshop or production line is transformed, resulting in changes in production conditions that may affect the safety and effectiveness of medical devices, it shall be reported to the original issuing department. If it is a change in the licensing matter, the relevant permit change procedures shall be handled in accordance with the regulations.

Article 16 If the name, legal representative (person in charge of the enterprise), domicile or literal change of the production address, or the reduction of the scope of production, an application shall be made to the original issuing department for a change of registration matters within 30 working days after the change, and relevant materials shall be submitted. The original issuing department shall complete the change of registration matters within 5 working days.

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

The original issuing department shall review the company's compliance with medical device management laws and regulations, medical device production quality management standards, and the operation of the enterprise's quality management system, carry out on-site verification when necessary, and make a decision on whether to approve the renewal of the medical device production license before the expiration of the validity period.

If the prescribed conditions are met after review, the renewal will be granted, and the renewed medical device production license number will remain unchanged. if the prescribed conditions are not met, they shall be ordered to make corrections within a time limit; If the prescribed conditions are still not met after rectification, it will not be continued, and the reasons shall be explained in writing.

If the approval time of the renewal license is within the validity period of the original license, the start date of the renewal is the day after the expiration date of the original license; If the approval time is not within the validity period of the original license, the start date of the renewal is the date on which the renewal license is approved.

Article 18 Where a medical device manufacturer establishes a production site across provinces, autonomous regions and municipalities directly under the Central Government, it shall apply for a medical device production license from the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the new production site is located.

Article 19 If the medical device production license is lost, it shall apply to the original issuing department for reissuance. The original issuing department shall promptly reissue the medical device production license, and the reissued medical device production license number and validity period shall be consistent with the original license.

Article 20 If the original or copy of the medical device production license is changed, the issuing department shall reissue the original or copy of the changed medical device production license and withdraw the original license. If only the copy is changed, the issuing department shall reissue the changed copy of the medical device production license and retrieve the copy of the original license. The changed medical device production license number and validity period remain unchanged.

Article 21 In any of the following circumstances, the original issuing department shall cancel the medical device production license in accordance with the law and make an announcement:

(1) Voluntarily applying for cancellation;

(2) The validity period has not been renewed after the expiration date;

(3) The qualifications of market entities are terminated in accordance with law;

(4) The medical device production license is revoked or revoked in accordance with law;

(5) Other circumstances in which laws and regulations stipulate that administrative licenses should be revoked.

Article 22 Those engaged in the production of Class I medical devices shall file with the department responsible for drug supervision and administration at the districted municipal level where they are located, and complete the production filing and obtain the filing number after submitting the relevant materials specified in Article 10 of these Measures. If the medical device filer manufactures Class I medical devices by himself, he or she may handle the production filing at the same time as the product filing.

Article 23 If the content of the production filing of Class I medical devices changes, the materials related to the changes stipulated in Article 10 of these Measures shall be submitted to the original filing department within 10 working days, and the drug regulatory department may carry out on-site verification in accordance with the provisions of Article 22 of these Measures when necessary.

Article 24 No unit or individual shall forge, alter, buy, sell, lease, or lend a medical device production license.

Article 25 Medical device registrants, filers, and entrusted manufacturers shall establish and improve a quality management system suitable for the medical devices produced and maintain their effective operation in accordance with the requirements of the medical device production quality management specifications, and organize production in strict accordance with the registered or filed product technical requirements to ensure that the medical devices leaving the factory meet the mandatory standards and the registered or filed product technical requirements.

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

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

Article 28 Medical device registrants, filers, and entrusted manufacturers shall carry out training on medical device laws, regulations, rules, standards, and quality management, establish training systems, formulate training plans, strengthen assessments, and make training records.

Article 29 Medical device registrants, filers, and entrusted manufacturers shall reasonably equip and use facilities and equipment in accordance with the characteristics, technological processes, and production environment requirements of the products they produce, strengthen the management of facilities and equipment, and maintain their effective operation.

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

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

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

Article 32 Where a medical device registrant or filer entrusts production, it shall evaluate the quality assurance and risk management capabilities of the entrusted party, sign a quality agreement and entrustment agreement with the entrusted party in accordance with the requirements of the entrusted production quality agreement guidelines formulated by the State Medical Products Administration, and supervise the entrusted party to perform the obligations stipulated in the relevant agreement.

The entrusted manufacturer shall organize production in accordance with laws, regulations, rules, medical device production quality management specifications, mandatory standards, product technical requirements, entrusted production quality agreements, etc., be responsible for the production behavior, and accept the supervision of medical device registrants and filers.

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

Encourage medical device registrants, filers, and entrusted manufacturers to adopt advanced technology and establish information management systems to strengthen the management of production processes.

Article 34 The registrant and filer of medical devices shall be responsible for the listing of the productRelease, establish product listing release procedures, clarify release standards and conditions, and review medical device production process records and quality inspection results. If the production is entrusted, the medical device registrant and filer shall also review the production release documents of the entrusted manufacturer.

The entrusted production enterprise shall establish production release procedures, clarify the standards and conditions for production release, and confirm that it meets the standards and conditions before leaving the factory.

Those that do not meet the laws, regulations, rules, mandatory standards, and registered or filed product technical requirements shall not be released from the factory or listed.

Article 35 Medical device registrants and filers shall establish and implement a product traceability system to ensure product traceability. The entrusted manufacturer shall assist the registrant and the filer to implement product traceability.

Article 36 Medical device registrants, filers, and entrusted manufacturers shall carry out coding, data upload, maintenance and update in accordance with the relevant requirements of the state for the implementation of unique identification of medical devices, to ensure that the information is true, accurate, complete, and traceable.

Article 37 Medical device registrants, filers, and entrusted manufacturers shall establish corrective action procedures, determine the causes of problems, and take effective measures to prevent the recurrence of relevant problems.

Medical device registrants, filers, and entrusted manufacturers shall establish preventive measures procedures to find out the causes of potential problems and take effective measures to prevent problems from occurring.

Article 38 Medical device registrants and filers shall identify and control changes in raw materials and production processes that may affect product safety and effectiveness in accordance with the requirements of medical device production quality management standards. If it is necessary to change registration or filing, the relevant procedures shall be handled in accordance with the provisions of registration and filing management.

Article 39 After the implementation of the new mandatory standards, medical device registrants and filers shall promptly identify the differences between product technical requirements and mandatory standards, and if registration changes or filing changes are required, they shall go through relevant procedures in accordance with the provisions of registration and filing management.

Article 40 Medical device registrants, filers, and entrusted manufacturers shall implement adverse event monitoring responsibilities in accordance with relevant provisions on medical device adverse event monitoring, carry out adverse event monitoring, and report to the medical device adverse event monitoring technical institution on investigation, analysis, evaluation, product risk control, etc.

Article 41 If a medical device registrant or filer discovers that the medical device produced does not meet the mandatory standards, the technical requirements of the registered or filed product, or has other defects, it shall immediately stop production, notify the relevant business enterprises, user units and consumers to stop operating and using it, recall the medical device that has been put on the market, take measures such as remediation and destruction, record the relevant situation, and release relevant information. And report the recall and handling of medical devices to the drug regulatory department and the health department.

The entrusted manufacturer shall perform its responsibilities in accordance with the relevant provisions on medical device recall, and assist the medical device registrant and filer to implement the recall of the medical device produced.

Article 42 Medical device manufacturers shall report to the drug regulatory department on the variety of products they produce.

If the variety of products is increased, it shall be reported to the original production license or production filing department, and if it involves commissioned production, information such as the entrusting party, the entrusted production product, and the entrusted period shall also be provided.

If the increase in production conditions of medical device manufacturers involves changes in production conditions that may affect the safety and effectiveness of products, it shall report to the original production licensing department 30 working days before the increase in production products, and the original production licensing department shall carry out on-site verification in a timely manner. If it is a change in the licensing matter, the relevant license change shall be handled in accordance with the regulations.

Article 43 If a medical device manufacturer has stopped production for more than one year and there are no similar products in production, it shall conduct necessary verification and confirmation when re-production, and report to the drug regulatory department in writing. If it may affect quality and safety, the drug administration department may organize verification as needed.

Article 44 If the production conditions of medical device registrants, filers, and entrusted manufacturers change and no longer meet the requirements of the medical device quality management system, rectification measures shall be taken immediately; If it may affect the safety and effectiveness of medical devices, production activities shall be stopped immediately and reported to the original production license or production filing department.

The entrusted manufacturer shall promptly inform the medical device registrant and filer of the changes.

Article 45 Medical device registrants, filers, and entrusted manufacturers shall conduct self-inspections on the operation of the quality management system every year and submit a self-inspection report to the local drug regulatory department before March 31 of the following year. The registrant and filer of imported medical devices shall submit a self-inspection report to the drug administration department of the province, autonomous region or municipality directly under the Central Government where the agent is located.

Article 46 The drug regulatory department shall carry out supervision and inspection of the production activities of medical device registrants, filers and entrusted manufacturers in accordance with its duties in accordance with the law.

When necessary, the drug regulatory department may carry out extended inspections on other units and individuals that provide products or services for medical device production activities.

Article 47 The drug regulatory department shall establish and improve a system of professional and specialized medical device inspectors, and allocate sufficient inspectors according to regulatory authority, industrial scale, and inspection tasks to effectively ensure the needs of inspection work.

Inspectors shall be familiar with medical device laws and regulations, and have medical device professional knowledge and inspection skills.

Article 48 The drug regulatory department shall implement hierarchical management and dynamic adjustment of medical device registrants, filers, and entrusted manufacturers according to the risk degree of the product and enterprise.

The State Medical Products Administration organizes the formulation of a list of key supervised products. The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government determine the list of key supervised products in their respective administrative regions based on actual conditions.

The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall organize and implement hierarchical supervision and management based on the key supervision product catalogues and the production quality management status of medical devices, combined with factors such as adverse medical device events, product complaints and reports, and enterprise credit status.

Article 49 The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall formulate annual medical device production supervision and inspection plans, determine the key points of medical device supervision and management, clarify the frequency and coverage of inspections, and comprehensively use various forms such as supervision and inspection, key inspections, follow-up inspections, cause-based inspections, and special inspections to strengthen supervision and management.

Enterprises producing key supervised product catalog varieties shall be inspected at least once a year.

Article 50 When organizing supervision and inspection, the drug regulatory department shall formulate an inspection plan, clarify the inspection matters and basis, truthfully record the on-site inspection, and inform the inspected enterprise of the inspection results in writing. Where rectification is required, the content and time limit for rectification shall be clarified.

When the drug administration department conducts supervision and inspection, it shall assign two or more inspectors to carry out supervision and inspection. Law enforcement personnel shall present law enforcement certificates to the inspected units, and other inspectors shall present inspector cards or documents indicating their identities.

Article 51 The drug regulatory department shall focus on supervision and inspection of medical device registrants and filers who produce their own products:

(1) The implementation of laws and regulations by medical device registrants and filers and medical device production quality management norms;

(2) Organize production in accordance with mandatory standards and the technical requirements of registered and filed products, and the actual production is consistent with the registration and filing of medical devices and medical device production licenses;

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

(4) Legal representatives, enterprise leaders, manager representatives, and other personnel are familiar with the laws and regulations related to medical devices;

(5) The performance of duties by the manager's representatives;

(6) Changes in legal representatives, enterprise leaders, manager representatives, quality inspection institutions or full-time personnel, production sites, environmental conditions, key production and inspection equipment, etc.;

(7) Corrective and preventive measures for problems found in user feedback and internal audits;

(8) The rectification and implementation of problems found in enterprise product sampling inspections, supervision and inspection, complaints and reports;

(9) Internal audit, management review, change control, annual self-inspection report, etc.;

(10) Other contents that should be focused on inspection.

Article 52 Where the drug regulatory department adopts the method of entrusted production of medical device registrants and filers, it shall focus on the following inspections when carrying out supervision and inspection:

(1) The implementation of laws and regulations and medical device production quality management norms by medical device registrants and filers;

(2) Whether the operation of the quality management system is continuous and effective;

(3) The performance of duties by manager representatives;

(4) Organize production in accordance with mandatory standards and registered or filed product technical requirements;

(5) Corrective and preventive measures for problems found in user feedback and internal audits;

(6) Internal audit, management review, change control, annual self-inspection report, etc.;

(7) Carry out adverse event monitoring, re-evaluation, and product safety risk information collection and assessment;

(8) The listing and release of the product;

(9) Supervision of entrusted production enterprises, performance of entrusted production quality agreements, design conversion and change control of entrusted products, production release of entrusted products, etc.;

(10) Other contents that should be focused on inspection.

If necessary, the entrusted production enterprise may be inspected.

Article 53 The drug regulatory department shall focus on the following inspections when carrying out supervision and inspection of entrusted manufacturers:

(1) The consistency between the actual production and the registration and filing of medical devices and medical device production licenses;

(2) The implementation of laws and regulations and medical device production quality management standards by the entrusted manufacturer;

(3) Legal representatives, enterprise leaders, manager representatives, and other personnel should understand and be familiar with the laws and regulations related to medical devices;

(4) Changes in legal representatives, enterprise leaders, manager representatives, quality inspection institutions or full-time personnel, production sites, environmental conditions, key production and inspection equipment, etc.;

(5) The production and release of products;

(6) The implementation of rectification and implementation of problems found in product sampling inspections, supervision and inspection, complaints and reports;

(7) Internal audits, management reviews, annual self-inspection reports, etc.;

(8) Other contents that should be focused on inspection.

If necessary, the medical device registrant and filer may be inspected.

Article 54 Where the drug administration department finds that there may be serious quality and safety risks in the monitoring of adverse events, spot checks, complaints and reports, etc., it shall carry out inspections with cause. In principle, the inspection shall be carried out in a non-advance manner.

Article 55 The drug regulatory department shall carry out follow-up inspections on the rectification of enterprises.

Follow-up inspection can conduct a written review of the rectification report submitted by the enterprise, and can also conduct an on-site review of the enterprise's problem rectification, responsibility implementation, corrective and preventive measures, etc.

Article 56 Where the medical device registrant and the entrusted 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 where the medical device registrant is located shall be responsible for supervising and inspecting the registrant's performance of statutory obligations such as the operation of the quality management system, adverse event monitoring, and product recall. The drug regulatory department where the entrusted manufacturer is located shall cooperate.

The drug regulatory departments of the provinces, autonomous regions, and municipalities directly under the Central Government where the medical device registrant and entrusted manufacturer are located shall separately implement territorial regulatory responsibilities, establish collaborative supervision mechanisms, strengthen regulatory information communication, and achieve effective regulatory connection.

Article 57 If the medical device registrant and the entrusted manufacturer 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 where the medical device registrant or entrusted manufacturer is located needs to carry out cross-regional inspections, joint inspections or commissioned inspections may be carried out by means of joint inspections or commissioned inspections.

Article 58 If defects in the quality management system of enterprises are found during cross-regional inspections, the drug regulatory departments of the provinces, autonomous regions, and municipalities directly under the Central Government where the medical device registrants and entrusted manufacturers are located shall, in accordance with their respective responsibilities, urge the relevant enterprises to make timely rectifications in strict accordance with the requirements, and promptly report the inspection and rectification to the relevant drug regulatory departments.

If relevant problems are found to involve the registrant during the supervision and inspection of the entrusted manufacturer, the drug regulatory department where the registrant is located shall be notified. If it is found that there may be quality and safety risks of medical devices, risk control measures shall be taken immediately and the relevant situation shall be reported to the drug regulatory department where the registrant is located. After receiving the notification, the drug regulatory department where the registrant is located shall immediately conduct analysis and judgment and take corresponding risk control measures.

If relevant problems are found in the supervision and inspection of the registrant involving the entrusted manufacturer, it shall be reported to the drug supervision and administration department where the entrusted manufacturer is located, and the drug supervision and administration department where the entrusted manufacturer is located shall jointly or entrust the entrusted manufacturer to conduct the inspection.

Article 59 If possible illegal acts are found during cross-regional inspections, the drug regulatory departments of the provinces, autonomous regions, or municipalities directly under the Central Government where the medical device registrant and entrusted manufacturer are located shall investigate and deal with them in accordance with their respective duties. The handling of illegal acts shall be promptly reported to the relevant drug regulatory departments.

If it is necessary to conduct cross-regional investigation and collect evidence, it may carry out a joint investigation with the relevant drug regulatory departments at the same level, or issue a letter of assistance to request the relevant drug regulatory departments at the same level to assist in the investigation and collect evidence.

Article 60 Where the filer of Class I medical devices and the entrusted manufacturer are not in the same districted city, and it is necessary to carry out cross-regional supervision, inspection, investigation and evidence collection in accordance with their duties in accordance with the law, the provisions of Articles 56 to 59 of these Measures shall be implemented with reference to the provisions of Articles 56 to 59 of these Measures.

Article 61 The registrant or filer of imported medical devices shall designate a legal person of an enterprise in our country as an agent, and the agent shall assist the registrant or filer in performing the obligations stipulated in the Regulations on the Supervision and Administration of Medical Devices and these Measures.

Article 62 The production of imported medical devices shall meet the relevant requirements of medical device production in our country and be subject to overseas inspections organized by the State Medical Products Administration. The agent is responsible for coordinating and cooperating with overseas inspections。

If the registrant, filer or agent of imported medical devices refuses, obstructs, delays or evades the overseas inspection organized by the State Medical Products Administration, resulting in the inability to carry out the inspection work and the inability to confirm the effective operation of the quality management system, which is a situation where there is evidence to prove that it may endanger human health, the State Medical Products Administration may deal with it in accordance with the provisions of Article 72, paragraph 2 of the Regulations on the Supervision and Administration of Medical Devices.

Article 63 When the drug regulatory department conducts on-site inspections, it may conduct spot checks and inspections as needed.

Article 64 Where the produced medical device causes harm to the human body or there is evidence that it may endanger human health, the drug regulatory department may take emergency control measures to suspend production, import, operation, and use, and issue safety warning information.

If it is found during supervision and inspection that production activities seriously violate the quality management standards for medical device production, cannot ensure product safety and effectiveness, and may endanger human health, it shall be dealt with in accordance with the provisions of the preceding paragraph.

Article 65 The drug regulatory department shall regularly organize and carry out risk consultations, analyze and evaluate the quality and safety risks of medical devices within its jurisdiction, and take corresponding risk control measures in a timely manner.

Article 66 If the medical device registrant, filer, or entrusted manufacturer fails to take effective measures to eliminate the existing quality and safety risks of medical devices, the drug regulatory department may conduct a responsibility interview with the medical device registrant, filer, legal representative of the entrusted manufacturer, or the person in charge of the enterprise. If cross-regional entrusted production is involved, the interview shall be reported to the relevant drug regulatory department.

Article 67 The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall establish and promptly update the credit files of registrants and entrusted manufacturers of Class II and Class III medical devices within their jurisdictions, and the departments responsible for drug supervision and administration at the districted municipal level shall establish and promptly update the credit files of Class I medical device registrants and entrusted manufacturers within their jurisdiction in accordance with their duties in accordance with law.

The credit file shall include information such as the filing of production licenses and the variety of products produced, entrusted production, supervision and inspection results, investigation and handling of illegal acts, quality spot checks and inspections, records of bad behavior, and complaints and reports.

For medical device registrants, filers, and entrusted manufacturers with bad credit records, the drug regulatory department shall increase the frequency of supervision and inspection, and strengthen punishment for dishonesty in accordance with law.

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

If the entrusted manufacturer increases the production of Class II or Class III medical devices, and is not in the same province, autonomous region, or municipality directly under the Central Government as the registrant of the product, or increases the production of Class I medical devices, and is not in the same districted city as the product filer, the drug regulatory department where the entrusted manufacturer is located shall also notify the drug regulatory department where the registrant or filer is located.

Article 69 The drug regulatory department shall publish the contact information for receiving complaints and reports. The drug regulatory department that receives the report shall promptly verify, handle and reply. If it is verified to be true, the informant shall be rewarded in accordance with relevant provisions.

Article 70 If the drug regulatory department discovers suspected illegal acts during supervision and inspection, it shall promptly collect and fix evidence, and file a case for investigation and punishment in accordance with law; if a crime is suspected, it shall be promptly handed over to the public security organs for handling.

Article 71 The drug administration department and its staff shall keep confidential the trade secrets learned during investigation and inspection.

Article 72 In supervision and inspection, drug regulatory departments and their staff shall strictly regulate fair and civilized law enforcement, strictly enforce integrity and discipline, and shall not solicit or accept property, seek other benefits, or hinder the normal production activities of enterprises.

Article 73 Where the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations have already provided for illegal acts in the production of medical devices, those provisions shall be followed.

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

(1) Producing Class II and Class III medical devices beyond the production scope specified in the medical device production license;

(2) Producing Class II and Class III medical devices at unlicensed production sites;

(3) After the expiration of the validity period of the medical device production license, the person continues to engage in the production of Class II and Class III medical devices without going through the renewal procedures in accordance with the law;

(4) Medical device manufacturers should handle license changes in accordance with the law but fail to increase the variety of products they produce.

Article 75 Failure to handle the production and filing change of Class I medical devices in accordance with the provisions of these Measures shall be handled in accordance with the provisions of Article 84 of the Regulations on the Supervision and Administration of Medical Devices.

Article 76 Where the quality management specifications for medical device production are violated, the drug regulatory department shall order corrections within a time limit in accordance with their duties; If it affects the safety and effectiveness of medical device products, it shall be punished in accordance with the provisions of Article 86 of the Regulations on the Supervision and Administration of Medical Devices.

Article 77 Violation of the provisions of Article 15, Paragraph 2 and Article 42, Paragraph 3 of these Measures, changes in production conditions, which may affect the safety and effectiveness of products, and production without reporting in accordance with the regulations, shall be punished in accordance with the provisions of Article 88 of the Regulations on the Supervision and Administration of Medical Devices.

Article 78 In any of the following circumstances, the drug regulatory department shall give a warning and impose a fine of not less than 10,000 yuan but not more than 50,000 yuan in accordance with its duties:

(1) The medical device manufacturer fails to report to the drug regulatory department the product varieties and relevant information in accordance with the provisions of Paragraph 2 of Article 42 of these Measures;

(2) Production has been suspended for more than one year and there are no similar products in production, and the necessary verification and confirmation have not been carried out and reported to the local drug administration department when re-production.

Article 79 In any of the following circumstances, the drug administration department shall order corrections within a time limit in accordance with its duties; if they refuse to make corrections, they shall be fined between 10,000 and 50,000 yuan; If the circumstances are serious, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed:

(1) Failure to handle the change of medical device production license registration matters in accordance with the provisions of Article 16 of these Measures;

(2) Failing to organize and carry out coding, data uploading, maintenance and update in accordance with the relevant requirements of the state for the implementation of unique identification of medical devices.

Article 80 Personnel of drug regulatory departments who violate the provisions of these Measures, abuse their power, neglect their duties, or engage in corruption for personal gain shall be punished in accordance with law.

Article 81 These Measures shall come into force on May 1, 2022. The "Measures for the Supervision and Administration of Medical Device Production" promulgated by the former State Food and Drug Administration Order No. 7 on July 30, 2014 shall be repealed at the same time.