Measures for the Supervision and Administration of the Operation of Medical Devices

                                                                                             Chapter 1 General Provisions

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

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

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

Medical device registrants and filers can sell them by themselves, or they can entrust medical device business enterprises to sell their registered and filed medical devices.

Article 4 According to the degree of risk of medical devices, the operation of medical devices shall be subject to classified management.

The operation of Class III medical devices is subject to licensing management, the operation of Class II medical devices is subject to recordation management, and the operation of Class I medical devices does not require license and recordation.

Article 5 The State Drug Administration shall be in charge of the supervision and administration of the operation of medical devices nationwide.

The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of the operation of medical devices within their respective administrative regions.

The departments responsible for drug supervision and administration at the city and county levels divided into districts shall be responsible for the supervision and administration of medical device operation within their respective administrative regions.

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

Article 7 The State Drug Administration strengthens the information construction of medical device business 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 shall be responsible for the informatization construction and management of medical device business supervision and management in their respective administrative regions, and coordinate and promote the sharing of medical device business supervision and management information in accordance with the requirements of the State Drug Administration.

Article 8 The drug regulatory department shall promptly disclose information such as medical device business license and filing, as well as the results of supervision, inspection and administrative punishment in accordance with the law, so as to facilitate public inquiries and accept social supervision.

                                                                                             Chapter II Business License and Record Management

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

(1) Quality management institutions or quality management personnel suitable for the business scope and business scale, and the quality management personnel shall have relevant professional qualifications or professional titles;

(2) The business premises commensurate with the business scope and business scale;

(3) Storage conditions commensurate with the business scope and business scale;

(4) The quality management system suitable for the medical devices in business;

(5) Quality management institutions or personnel for professional guidance, technical training and after-sale services that are compatible with the operating medical devices.

Enterprises engaged in the business of Class III medical devices shall also have a computer information management system that meets the requirements of the medical device business quality management system to ensure the traceability of the products they operate. Enterprises engaged in the operation of Class I and Class II medical devices are encouraged to establish a computer information management system that meets the requirements of the quality management system for medical device operations.

Article 10 To engage in the business of Class III medical devices, the business enterprise shall file an application with the department in charge of drug supervision and administration at the city divided into districts where it is located, and submit the following materials:

(1) A copy of the legal representative (person in charge of the enterprise), the identity certificate of the person in charge of quality, and the photocopies of the relevant materials of education or professional title;

(2) The organizational structure and departmental setup of the enterprise;

(3) The business scope and business mode of medical devices;

(4) The geographic location map, floor plan, house property document or copy of the lease agreement of the business premises and warehouse;

(5) Catalogue of main operating facilities and equipment;

(6) Catalogue of documents such as business quality management systems and work procedures;

(7) Basic information on the information management system;

(8) Authorization documents of the handler.

An applicant for a medical device business license shall ensure that the submitted materials are legal, true, accurate, complete and traceable.

Article 11 After receiving the application, the department in charge of drug supervision and administration at the city level with districts shall deal with it according to the following circumstances:

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

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

(3) If the application materials are incomplete or do not conform to the statutory form, the applicant shall be notified on the spot or within 5 working days of all the contents that need to be supplemented and corrected. If the application is not notified within the time limit, it will be accepted from the date of receipt of the application materials;

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

If the department in charge of drug supervision and administration at the city level with districts accepts or rejects an application for a medical device business license, it shall issue a notice of acceptance or rejection affixed with the special seal of the administrative organ and dated.

Article 12 With regard to the matters requiring hearing for the implementation of administrative licensing as stipulated by laws, regulations and rules, or other major administrative licensing matters involving public interests that the drug regulatory department deems to require a hearing, the drug regulatory department shall announce to the public and hold a hearing. Where an application for a medical device business license directly involves a major interest relationship between the applicant and others, the drug regulatory department shall inform the applicant and interested parties that they have the right to request a hearing before making an administrative licensing decision.

Article 13 The department in charge of drug supervision and administration at the city level divided into districts shall, after accepting the application for business license, review the application materials, and if necessary, carry out on-site inspection in accordance with the requirements of the quality management standard for medical device business, and from the date of acceptance A decision will be made within 20 working days. If rectification is required, the rectification time is not included in the review time limit.

If the prescribed conditions are met, a written decision to grant the license shall be made, and a medical device business license shall be issued within 10 working days;

Article 14 The medical device business license is valid for 5 years, indicating the license number, enterprise name, unified social credit code, legal representative, person in charge of the enterprise, domicile, business place, business method, business scope, warehouse address, Matters such as issuing department, issuing date and validity period.

The medical device business license is unified by the State Drug Administration and printed by the department responsible for drug supervision and administration at the city level with districts.

The electronic certificate of the medical device business license produced by the drug regulatory department has the same legal effect as the paper certificate.

Article 15 If the medical device business license is changed, an application for the modification of the medical device business license shall be submitted to the original license-issuing department, and the relevant materials related to the changed content as stipulated in Article 10 of these Measures shall be submitted. In the event of a change of business premises, business mode, business scope, and warehouse address, the drug regulatory department shall make a decision to approve or not to change within 20 working days from the date of acceptance. If necessary, conduct on-site inspections in accordance with the requirements of the medical device business quality management standards.

If rectification is required, the rectification time is not included in the review time limit. If no change is made, the reasons shall be explained in writing and the applicant shall be informed. If other matters are changed, the drug supervision and administration department shall make changes on the spot.

The number and validity period of the changed medical device business license remain unchanged.

Article 16 If the validity period of the medical device business license needs to be renewed, the medical device business enterprise shall file a renewal application within 90 working days to 30 working days before the validity period expires. If the renewal application is not submitted within the time limit, the renewal application will not be accepted.

The original license-issuing department shall review the renewal application in accordance with the provisions of Article 13 of these Measures, conduct on-site inspection if necessary, and make a decision on whether to approve the renewal before the expiration of the medical device business license.

If it meets the prescribed conditions after review, the extension will be granted, and the number of the extended medical device business license will remain unchanged. Those who do not meet the prescribed conditions shall be ordered to rectify within a time limit; those who still do not meet the prescribed conditions after rectification shall not be renewed, and the reasons shall be explained in writing. If a decision is not made within the time limit, it shall be deemed to be granted a continuation.

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

Article 17 If the operating enterprise sets up warehouses in a city divided into districts, the medical device business license issuing department or the filing department shall notify the department in charge of drug supervision and administration at the districted city level where the warehouse is located.

Article 18 If a business enterprise establishes a new independent business place, it shall separately apply for a medical device business license or record it according to law.

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

Article 20 Under any of the following circumstances, the original license-issuing department shall cancel the medical device business license according to law, and make an announcement:

(1) voluntarily apply for cancellation;

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

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

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

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

Article 21 To engage in the business of Class II medical devices, the business enterprise shall file with the department in charge of drug supervision and administration at the city divided into districts where it is located, and submit materials that comply with Article 10 of these Measures (except for item 7), That is, the operation record is completed and the operation record number is obtained.

The recorder of medical device business shall ensure that the submitted materials are legal, true, accurate, complete and traceable.

Article 22 When necessary, the department responsible for drug supervision and administration at the city level with districts shall, within 3 months from the date of completing the filing, conduct on-site inspections of the submitted materials and the implementation of the quality management practices for medical device business.

If the on-site inspection finds that it is inconsistent with the submitted materials or does not meet the requirements of the medical device business quality management standard, it shall be ordered to make corrections within a time limit; if the product safety and effectiveness cannot be guaranteed, the filing shall be cancelled and an announcement shall be made to the public.

Article 23 Those who apply for a Class III medical device business license and conduct a Class II medical device business record at the same time, or have obtained a Class III medical device business license for a Class II medical device record, may be exempted from submitting the corresponding materials .

Article 24 If the business premises, business mode, business scope, warehouse address, etc. of the second-class medical device business enterprise change, it shall make a record change in a timely manner. When necessary, the department responsible for drug supervision and administration at the city level with districts shall conduct on-site inspections. If the on-site inspection does not meet the requirements of the medical device business quality management standard, it will be ordered to make corrections within a time limit; if the product safety and effectiveness cannot be guaranteed, the recordation will be cancelled and an announcement will be made to the public.

Article 25 Class II medical devices whose product safety and effectiveness are not affected by the circulation process may be exempted from business filing. The specific product list shall be formulated, adjusted and published by the State Drug Administration.

Article 26 Institutions engaged in the storage, allocation and supply of non-profit contraceptive medical devices shall comply with relevant regulations and do not need to apply for a medical device business license or record.

Article 27 Medical device registrants and filers who sell their registered and filed medical devices at their domicile or production address do not need to apply for a medical device business license or filing, but shall meet the prescribed business conditions; store and sell them in other places For medical devices, the medical device business license or filing shall be handled in accordance with the regulations.

Article 28 No unit or individual may forge, alter, trade, lease or lend a medical device business license.

                                                                                            Chapter 3 Operational Quality Management

Article 29 To engage in medical device business, it is necessary to establish a quality management system and quality control measures covering the whole process of procurement, acceptance, storage, sales, transportation, and after-sales service in accordance with laws and regulations and the requirements of quality management standards for medical device business. And make relevant records to ensure that operating conditions and operating activities continue to meet the requirements.

Article 30 A medical device business enterprise shall establish and implement a product traceability system to ensure product traceability.

Medical device business enterprises shall implement the unique identification system for medical devices in accordance with relevant state regulations.

Article 31 A medical device business enterprise shall purchase medical devices from legally qualified medical device registrants, record holders and business enterprises.

Article 32 A medical device business enterprise shall establish a purchase inspection record system, and when purchasing medical devices, it shall inspect the qualifications of the supplier, as well as the medical device registration certificate and filing information, and qualification certificates. The incoming inspection records shall be true, accurate, complete and traceable. Incoming inspection records include:

(1) The name, model, specification and quantity of the medical device;

(2) Medical device registration certificate number or filing number;

(3) Names, production license numbers or filing numbers of the medical device registrant, filing and entrusted manufacturing enterprise;

(4) The production batch number or serial number, use period or expiration date, purchase date, etc. of the medical device;

(5) The name, address and contact information of the supplier.

The incoming inspection records shall be kept for 2 years after the expiration date of the medical device; if there is no validity period, it shall not be less than 5 years. Implantable medical device purchase inspection records shall be kept permanently.

Article 33 A medical device business enterprise shall take effective measures to ensure that the transportation and storage of medical devices meet the requirements of medical device instructions or labels, and make corresponding records.

If there are special requirements for environmental conditions such as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of medical devices.

Article 34 If the medical device registrant, filing and operating enterprise entrusts other units to transport and store medical devices, they shall evaluate the quality assurance capability of the entrusted party in transporting and storing medical devices, and sign an entrustment agreement with them, specifying the transportation, Quality responsibility during storage to ensure quality safety during transportation and storage.

Article 35 Those who specially provide transportation and storage services for medical device registrants, filers and operating enterprises shall sign a written agreement with the entrusting party, clarifying the rights, obligations and quality responsibilities of both parties, and have the conditions and scale of product transportation and storage. Appropriate equipment and facilities, with information management platform and technical means to carry out real-time electronic data exchange with the entrusting party and realize the traceability of the whole process of product operation and quality management.

Article 36 If a medical device registrant or filer entrusts sales, it shall entrust a qualified medical device business enterprise, and sign an entrustment agreement to clarify the rights and obligations of both parties.

Article 37 Medical device registrants, filing and operating enterprises shall strengthen the training and management of sales personnel, and bear legal responsibility for the purchase and sale of medical devices by sales personnel in the name of the enterprise.

Article 38 The operating enterprises engaged in the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices shall establish a sales record system. The sales record information shall be true, accurate, complete and traceable. Sales records include:

(1) The name, model, specification, registration certificate number or filing number, quantity, unit price, and amount of the medical device;

(2) The production batch number or serial number, use period or expiration date, and sales date of the medical device;

(3) The names of the medical device registrant, filing and entrusted manufacturing enterprise, production license number or filing number.

For enterprises engaged in the wholesale business of Class II and Class III medical devices, the sales records shall also include the purchaser's name, address, contact information, relevant license document number or filing number, etc.

The sales records shall be kept for 2 years after the expiration of the validity period of the medical device; if there is no validity period, it shall not be less than 5 years. Implantable medical device sales records shall be kept permanently.

Article 39 A medical device operating enterprise shall provide after-sales service. If it is agreed that the supplier or other organization will provide after-sales service, the operating enterprise shall strengthen management to ensure the safe use of medical devices after sales.

Article 40 The medical device business enterprise shall assign full-time or part-time personnel to be responsible for after-sales management, find out the reasons for the quality problems complained by customers, take effective measures to deal with and give feedback in a timely manner, keep records, and promptly notify the medical device registrant when necessary , filing person, production and operation enterprises.

Article 41 A medical device operating enterprise shall assist the medical device registrant and filer to monitor the adverse events of the medical devices it operates, and report to the technical institution for monitoring adverse events of medical devices in accordance with the provisions of the State Drug Administration.

Article 42 If a medical device operating enterprise finds that the medical device it operates does not meet the mandatory standards, the technical requirements for registered or filed products, or has other defects, it shall immediately stop the operation and notify the medical device registrant, recorder, etc. Relevant units, and record the cessation of operations and notification. If the medical device registrant or filing party thinks it needs to be recalled, it should be recalled immediately.

Article 43 A Class III medical device business enterprise that has been suspended for more than one year shall conduct necessary verification and confirmation before resuming business operations, and shall report in writing to the department in charge of drug supervision and administration at the city level with districts where it is located. If the quality and safety may be affected, the drug supervision and administration department may organize inspections as needed.

If the operating conditions of medical device registrants, filers, or operating enterprises have undergone major changes and no longer meet the requirements of the medical device business quality management system, rectification measures should be taken immediately; if the safety and effectiveness of medical devices may be affected, business activities should be stopped immediately, and Report to the original business license or filing department.

Article 44 The medical device business enterprise shall establish a quality management self-inspection system, conduct self-inspection in accordance with the requirements of the medical device business quality management standard, and submit the previous year's report to the local city and county-level drug supervision and management department before March 31 each year. Self-examination report.

Article 45 Those engaged in medical device business activities shall not operate medical devices that have not been registered or filed according to law, have no qualification certificates, and have expired, invalidated, or eliminated.

It is prohibited to import and sell expired, expired, obsolete and other used medical devices.

                                                                                             Chapter IV Supervision and Inspection

Article 46 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall organize the supervision and inspection of the supervision and administration of medical device business in their respective administrative regions.

The departments responsible for drug supervision and administration at the city and county levels divided into districts shall be responsible for the supervision and inspection of medical device business activities in their respective administrative regions.

Article 47 According to the quality management of medical device operating enterprises and the risk level of the medical device products, the drug regulatory department shall implement classified and hierarchical management and make dynamic adjustments.

Article 48 The departments in charge of drug supervision and administration at the districted city and county levels shall formulate an annual inspection plan, clarify the focus of supervision, inspection frequency and coverage, and organize the implementation.

Article 49 The drug supervision and administration department organizes supervision and inspection. In principle, the inspection method shall adopt surprise supervision and inspection. There shall be no less than two people during the on-site inspection, and the law enforcement certificate shall be presented, and the on-site inspection shall be recorded truthfully. If the inspection finds that there are quality and safety risks or does not meet the requirements of the specification, the inspection result shall be notified in writing to the inspected enterprise. If rectification is required, the rectification content and the rectification period shall be specified, and follow-up inspection shall be carried out.

Article 50 The departments in charge of drug supervision and administration at the city and county levels divided into districts shall supervise and inspect the medical device business enterprises' compliance with the requirements of the medical device business quality management standard, and urge them to standardize their business activities.

Article 51 The department in charge of drug supervision and administration at the city level and county level with districts shall strengthen supervision and inspection in light of the situation reflected in the annual self-inspection report submitted by the medical device business enterprise.

Article 52 The drug regulatory department shall conduct key supervision and inspection on the following circumstances:

(1) Serious problems were found in the supervision and inspection of the previous year;

(2) Those who are subject to administrative penalties for violating relevant laws and regulations;

(3) The key inspection enterprises determined by the risk consultation;

(4) Those with bad credit records;

(5) Newly established medical device wholesale enterprises and third-class medical device retail enterprises whose operating conditions have undergone major changes;

(6) Specially providing storage and transportation services for other medical device registrants, filers, and production and operation enterprises;

(7) Other situations requiring key supervision and inspection.

Article 53 If the drug supervision and administration department finds that there may be serious quality and safety risks in adverse event monitoring, random inspection, complaints and reports, etc., in principle, it shall conduct a cause-based inspection. In principle, inspections are conducted without prior notice.

Article 54 According to the needs of medical device quality and safety risk prevention and control, the drug regulatory department may conduct extended inspections on other relevant units and individuals that provide products or services for medical device business activities.

Article 55 The warehouses set up by medical device business enterprises in cities with districts shall be supervised and inspected by the drug supervision and administration department where the warehouses are located.

The drug regulatory department where the medical device business enterprise is located and the drug regulatory department where the warehouse is located shall strengthen the sharing of regulatory information, and may conduct joint inspections when necessary.

Article 56 The drug supervision and administration department shall strengthen the random inspection of medical device business links, and shall promptly dispose of those that fail the random inspection and inspection.

The drug regulatory authorities at or above the provincial level shall issue medical device quality announcements in a timely manner based on the results of random inspections.

Article 57 If the medical devices in business cause 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 import, business, and use, and issue safety warning information.

During the supervision and inspection, it is found that the business activities seriously violate the medical device business quality management regulations, cannot guarantee the safety and effectiveness of the products, and may endanger human health, and shall be dealt with in accordance with the provisions of the preceding paragraph.

Article 58 The drug supervision and administration department shall conduct regular risk consultation, research and judgment according to the supervision and inspection, product sampling inspection, adverse event monitoring, complaint reporting, administrative punishment, etc., and do a good job in the investigation and prevention and control of medical device quality and safety hidden dangers.

Article 59 If the medical device registrant, filing person, and operating enterprise fail to take effective measures to eliminate the existing medical device quality and safety risks, the drug supervision and administration department may issue the legal representative of the medical device registrant, filing person, and operating enterprise. The person or the person in charge of the enterprise conducts a responsibility interview.

Article 60 The department in charge of drug supervision and administration at the level of a city divided into districts shall establish and update the credit files of medical device business enterprises within its jurisdiction in a timely manner. The credit file shall include information such as the license filing of the medical device business enterprise, the results of supervision and inspection, the investigation and punishment of illegal acts, quality random inspections, self-inspection reports, records of bad behaviors, and complaints and reports.

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

Article 61 The drug regulatory department shall publish the contact information for receiving complaints and reports. The drug regulatory department that receives the report shall verify, handle and reply in a timely manner. If verified, the whistleblower shall be rewarded in accordance with relevant regulations.

Article 62 When the drug supervision and administration department discovers suspected illegal acts during the supervision and inspection, it shall collect and fix evidence in a timely manner, and file a case for investigation and punishment according to law; if a crime is suspected, it shall be handed over to the public security organ for handling in a timely manner.

Article 63 The drug regulatory department and its staff shall keep confidential the business secrets learned during the investigation and inspection.

Article 64 During the supervision and inspection, the drug supervision and administration department and its staff shall strictly regulate the law enforcement in a fair and civilized manner, strictly enforce the discipline of clean government, shall not ask for or accept property, shall not seek other interests, and shall not hinder the normal business activities of enterprises.

                                                                                            Chapter 5 Legal Liability

Article 65 For illegal acts in the business of medical devices, if the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations have already stipulated, the regulations shall be followed.

Article 66 Anyone who falls under any of the following circumstances shall be ordered to make corrections within a time limit, and a fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed; if the circumstances are serious, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if harmful consequences are caused, a fine of 10 yuan shall be imposed. A fine of more than 10,000 yuan but not more than 200,000 yuan:

(1) The third-class medical device business enterprise changes the business place, business scope, business method, and warehouse address without authorization;

(2) After the expiration of the validity period of the medical device business license, they continue to engage in medical device business activities without going through the renewal procedures in accordance with the law.

Those who engage in the business activities of Class III medical devices without permission shall be punished in accordance with the provisions of Article 81 of the Regulations on the Supervision and Administration of Medical Devices.

Article 67 Those who violate the relevant requirements of the medical device business quality management regulations shall be ordered by the drug regulatory department to make corrections within a time limit; those that affect the safety and effectiveness of medical device products shall be punished in accordance with the provisions of Article 86 of the Regulations on the Supervision and Administration of Medical Devices.

Article 68 If a medical device business enterprise fails to submit the annual self-inspection report of the quality management system as required, or violates the provisions of these Measures to provide storage and transportation services for other medical device production and business enterprises, the drug regulatory department shall order it to make corrections within a time limit; Those who refuse to make corrections shall be fined not less than 10,000 yuan but not more than 50,000 yuan; if the circumstances are serious, they shall be fined not less than 50,000 yuan but not more than 100,000 yuan.

Article 69 If a Class III medical device operating enterprise fails to change the enterprise name, legal representative and person in charge in accordance with the provisions of these Measures, the drug regulatory department shall order it to make corrections within a time limit; if it refuses to make corrections, it shall be fined more than 5,000 yuan 3 A fine of less than 10,000 yuan.

Article 70 Any staff member of the drug supervision and administration department who violates the provisions of these Measures, abuses their powers, neglects their duties, or engages in favoritism and fraud shall be punished according to law.

                                                                                           Chapter VI Supplementary Provisions

Article 71 The meanings of the following terms in these Measures are:

Wholesale of medical devices refers to the business operation of medical devices that sells medical devices to medical device manufacturers, medical device operators, medical device users or other units that have reasonable needs for use.

Medical device retailing refers to the operation of medical devices that directly sell medical devices to consumers for personal use.

Article 72 Those engaged in online sales of medical devices shall abide by the relevant provisions of laws, regulations and rules.

Article 73 These Measures shall come into force on May 1, 2022. On July 30, 2014, the "Measures for the Supervision and Administration of Medical Device Operation" promulgated by the former State Food and Drug Administration Order No. 8 shall be repealed at the same time.