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 operations, standardize medical device business activities, and ensure the safety and effectiveness of medical devices.

Article 2 Engaging in medical device business 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 business activities shall comply with the requirements of laws, regulations, rules, mandatory standards, and medical device business quality management specifications to ensure that the information on the medical device business process is true, accurate, complete, and traceable.

Medical device registrants and filers can sell by themselves or entrust medical device operators to sell their registered and registered medical devices.

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

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

Article 5 The State Medical Products Administration is responsible for the supervision and management of medical device operation throughout the country.

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

The departments responsible for drug supervision and administration at the districted municipal and county levels shall be responsible for the supervision and management of medical device operation in their respective administrative regions.

Article 6 The drug regulatory department shall establish or designate professional and technical institutions for medical device inspection, inspection, monitoring and evaluation in accordance with the law, undertake relevant technical work and issue technical opinions in accordance with the division of duties, and provide technical support for the supervision and management of medical device operation.

Article 7 The State Medical Products Administration shall strengthen the informatization of medical device operation supervision and management, and improve 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 operation supervision and management in their respective administrative regions, and coordinate and promote the sharing of medical device operation 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 business licenses, filings, and the results of supervision and inspection and administrative punishment in accordance with the law, so as to facilitate public inquiries and accept social supervision.

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

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

(2) Business premises suitable for the scope and scale of business;

(3) Storage conditions suitable for the scope and scale of business;

(4) A quality management system suitable for the medical devices being operated;

(5) Quality management institutions or personnel with professional guidance, technical training and after-sales service suitable for the medical devices they operate.

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

Article 10 If the business is engaged in the operation of Class III medical devices, the operating enterprise shall submit an application to the department responsible for drug supervision and administration at the districted municipal level where it is located, and submit the following materials:

(1) Copies of the identity certificate, academic qualifications or professional titles of the legal representative (person in charge of the enterprise) and the person in charge of quality;

(2) The establishment of enterprise organizations and departments;

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

(4) Copies of geographical location maps, floor plans, property rights documents, or lease agreements of business premises and warehouses;

(5) Catalogue of main operating facilities and equipment;

(6) Catalogue of business quality management systems, work procedures, and other documents;

(7) Basic information of the information management system;

(8) Authorization documents of the handler.

The applicant for a medical device business license shall ensure that the submitted information is legal, true, accurate, complete and traceable.

Article 11 After receiving the application, the department responsible for drug supervision and administration at the districted municipal level 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 statutory form, the applicant shall be informed of all the contents that need to be corrected on the spot or within 5 working days. If the application materials are not notified within the time limit, they will be accepted from the date of receipt of the application materials;

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

If the department responsible for drug supervision and administration at the districted city accepts or does not accept the application for a medical device business license, it shall issue a notice of acceptance or rejection stamped with the special seal of the administrative organ and indicating 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 business license directly involves a major interest relationship between the applicant and others, the drug regulatory department shall inform the applicant and interested parties of their right to request a hearing before making an administrative licensing decision.

Article 13 After accepting the application for a business license, the department responsible for drug supervision and administration at the districted municipal level shall review the application materials, carry out on-site verification in accordance with the requirements of the medical device business quality management specifications if necessary, and make a decision within 20 working days from the date of acceptance. If rectification is required, the rectification time will not be included in the review time limit.

if the prescribed conditions are met, a written decision shall be made to approve the license and a medical device business license shall be issued within 10 working days; if the prescribed conditions are not met, a written decision shall be made to deny permission and explain the reasons.

Article 14 The medical device business license shall be valid for 5 years, specifying the license number, enterprise name, unified social credit code, legal representative, person in charge of the enterprise, domicile, business premises, business mode, business scope, warehouse address, issuing department, date of issuance and validity period.

The medical device business license shall be uniformly issued by the State Medical Products Administration and by the department responsible for drug supervision and administration at the districted municipal level.

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

Article 15 If the medical device business license is changed, an application for change of the medical device business license shall be submitted to the original issuing department, and relevant materials related to the content of the change in Article 10 of these Measures shall be submitted. If the business premises, business methods, business scope, and warehouse address are changed, the drug regulatory department shall make a decision to approve the change or not to change within 20 working days from the date of acceptance. If necessary, on-site verification shall be carried out in accordance with the requirements of the medical device operation quality management specifications.

If rectification is required, the rectification time will not be included in the review time limit. If the change is not made, the reasons shall be explained in writing and the applicant shall be informed. If other matters are changed, the drug regulatory department shall shallChange it on the spot.

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

Article 16 If the validity period of the medical device business license needs to be renewed upon expiration, the medical device business enterprise shall submit an application for renewal 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 renewal application in accordance with the provisions of Article 13 of these Measures, conduct on-site verification if necessary, and make a decision on whether to approve the renewal before the expiration of the validity period of the medical device business license.

If the prescribed conditions are met after review, the renewal will be granted, and the renewed medical device business license number will remain unchanged. if it does not meet the prescribed conditions, it shall be ordered to rectify 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 no decision is made within the time limit, it shall be deemed to be allowed to continue.

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 17 If an operating enterprise sets up a warehouse across a districted city, the medical device business license issuing department or the filing department shall notify the department responsible for drug supervision and administration at the districted city where the warehouse is located.

Article 18 If a business enterprise establishes a new independent business premises, it shall separately apply for a medical device business license or file it in accordance with the law.

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

Article 20 In any of the following circumstances, the original issuing department shall cancel the medical device business 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 business 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 21 If the business is engaged in the operation of Class II medical devices, the operating enterprise shall file with the department responsible for drug supervision and administration at the districted municipal level where it is located, and submit information that meets the provisions of Article 10 of these Measures (except for item 7), that is, complete the business filing and obtain the business registration number.

The medical device business filer shall ensure that the submitted information is legal, true, accurate, complete and traceable.

Article 22 When necessary, the department responsible for drug supervision and administration at the districted municipal level shall carry out on-site inspections of the submitted materials and the implementation of medical device business quality management standards within 3 months from the date of completion of the filing.

If the on-site inspection finds that it is inconsistent with the submitted information or does not meet the requirements of the medical device operation quality management specifications, it shall be ordered to make corrections within a time limit; If the product cannot be guaranteed to be safe and effective, cancel the filing and announce it to the public.

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

Article 24 If there is a change in the business premises, business methods, business scope, warehouse address, etc. of a Class II medical device business enterprise, it shall be filed and changed in a timely manner. If necessary, the departments responsible for drug supervision and administration at the district level shall carry out on-site inspections. If the on-site inspection does not meet the requirements of the medical device operation quality management specifications, it shall be ordered to make corrections within a time limit; If the product cannot be guaranteed to be safe and effective, cancel the filing and announce it 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 Medical Products 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 medical device business licenses or filings.

Article 27 Medical device registrants and filers who sell medical devices registered or filed by them at their domicile or production address do not need to apply for medical device business license or filing, but shall meet the prescribed business conditions; Where medical devices are stored and sold in other places, medical device business licenses or filings shall be applied for in accordance with regulations.

Article 28 No unit or individual shall forge, alter, buy, sell, lease or lend a medical device business license.

Article 29 Engaging in medical device business shall 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 the requirements of laws and regulations and medical device operation quality management norms. And make relevant records to ensure that business conditions and business activities continue to meet the requirements.

Article 30 Medical device business enterprises 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 national regulations.

Article 31 Medical device business enterprises shall purchase medical devices from medical device registrants, filers, and operating enterprises with legal qualifications.

Article 32 Medical device business enterprises shall establish a purchase inspection record system, and when purchasing medical devices, they shall check the qualifications of the suppliers, as well as the medical device registration certificate, filing information, and qualification certificates. The purchase inspection records shall be true, accurate, complete and traceable. The purchase inspection records include:

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

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

(3) Name, production license number or filing number of the medical device registrant, filer and entrusted manufacturer;

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

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

The purchase inspection record shall be kept until 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. Inspection records of implantable medical devices shall be permanently preserved.

Article 33 Medical device business enterprises shall take effective measures to ensure that the transportation and storage of medical devices comply with the requirements of medical device instructions or labeling, 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 Where medical device registrants, filers, and operating enterprises entrust other units to transport and store medical devices, they shall evaluate the quality assurance capabilities of the entrusted party for transporting and storing medical devices, and sign an entrustment agreement with them to clarify the quality responsibilities during transportation and storage, and ensure quality and safety during transportation and storage.

Article 35 Where transportation and storage services are provided specifically for medical device registrants, filers, and operating enterprises, a written agreement shall be signed with the entrusting party to clarify the rights, obligations and quality responsibilities of both parties, and have equipment and facilities suitable for product transportation and storage conditions and scale, and have an 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. <B1172> Article 36 Where 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, filers and operating enterprises shall strengthen the training and management of sales personnel, and bear legal responsibility for the purchase and sale of medical devices engaged in by sales personnel in the name of the enterprise.

Article 38 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. Sales record information shall be true, accurate, complete and traceable. Sales records include:

(1) Name, model, specification, registration certificate number or filing number, quantity, unit price, and amount of medical devices;

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

(3) The name of the medical device registrant, filer and entrusted manufacturer, 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 name, address, contact information, relevant license document number or filing number, etc.

Sales records shall be kept until 2 years after the expiration of the validity period of medical devices; if there is no validity period, it shall not be less than 5 years. Sales records of implantable medical devices shall be kept permanently.

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

Article 40 Medical device business enterprises shall be equipped with full-time or part-time personnel responsible for after-sales management, and shall find out the causes of customer complaints regarding quality problems, take effective measures to handle and give feedback in a timely manner, and make records, and promptly notify medical device registrants, filers, and production and operation enterprises when necessary.

Article 41 Medical device business enterprises shall assist medical device registrants and filers to carry out adverse event monitoring of medical devices they operate, and report to medical device adverse event monitoring technical institutions in accordance with the provisions of the State Medical Products Administration.

Article 42 If a medical device business enterprise discovers that the medical devices it operates do not meet mandatory standards, the technical requirements of registered or filed products, or have other defects, it shall immediately stop operating, notify the medical device registrant, filer and other relevant units, and record the suspension of operation and notification. If the medical device registrant or filer believes that a recall is necessary, it shall be recalled immediately.

Article 43 Before resuming business after being suspended for more than one year, a Class III medical device business enterprise shall conduct necessary verification and confirmation, and report in writing to the department responsible for drug supervision and administration at the districted municipal level where it is located. If it may affect quality and safety, the drug administration department may organize verification as needed.

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

Article 44 Medical device business enterprises shall establish a quality management self-inspection system, conduct self-inspection in accordance with the requirements of medical device operation quality management specifications, and submit the self-inspection report of the previous year to the local city and county level responsible drug supervision and management department before March 31 of each year.

Article 45 Those engaged in medical device business activities shall not operate medical devices that have not been registered or filed in accordance with the law, have no qualification certificates, and are expired, invalid, or obsolete.

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

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

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

Article 47 The drug regulatory department shall implement classified and hierarchical management and dynamically adjust according to the quality management of medical device operating enterprises and the risk degree of medical device products they operate.

Article 48 The departments responsible for drug supervision and administration at the districted city and county levels shall formulate annual inspection plans, clarify the supervision focus, inspection frequency and coverage, and organize implementation.

Article 49 The drug regulatory department shall organize supervision and inspection, and in principle, the inspection method shall adopt surprise supervision and inspection, with no less than two people during on-site inspection, and present law enforcement certificates to truthfully record the on-site inspection. If the inspection finds that there are quality and safety risks or does not meet the requirements of the specification, the inspection results shall be notified in writing to the inspected enterprise. Where rectification is necessary, the content and time limit for rectification shall be clarified, and follow-up inspections shall be conducted.

Article 50 The departments responsible for drug supervision and administration at the districted city and county levels shall supervise and inspect the compliance of medical device business enterprises with the requirements of medical device operation quality management specifications, and urge them to standardize their business activities.

Article 51 The departments responsible for drug supervision and administration at the districted city and county levels shall strengthen supervision and inspection in light of the situation reflected in the annual self-inspection report submitted by medical device business enterprises.

Article 52 The drug administration department shall conduct key supervision and inspection in the following situations:

(1) Serious problems are found during the supervision and inspection of the previous year;

(2) Receiving administrative penalties for violating relevant laws and regulations;

(3) Key inspection enterprises determined by risk consultation;

(4) Have a bad credit record;

(5) Newly established medical device wholesale enterprises and Category III medical device retail enterprises with major changes in operating conditions;

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

(7) Other situations that require key supervision and inspection.

Article 53 If the drug regulatory 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 causal inspections in principle. In principle, the inspection shall be carried out in a non-advance manner.

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

Article 55 The drug supervision and administration department where the warehouse is located shall be responsible for supervision and inspection of the warehouse set up by a medical device business enterprise across districted cities.

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 carry out joint inspections when necessary.

Article 56 The drug regulatory department shall strengthen spot checks and inspections in the operation of medical devices, and shall promptly deal with those that fail the random inspections.

The drug regulatory department at or above the provincial level shall promptly issue medical device quality announcements based on the results of random inspections.

Article 57 Where a medical device operated 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 the import, operation, or use, and issue a safety warningInformation.

If it is found that business activities seriously violate the quality management standards for medical device operation, 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 58 The drug regulatory departments shall regularly carry out risk consultations and judgments based on supervision and inspection, product sampling inspections, adverse event monitoring, complaints and reports, administrative penalties, etc., and do a good job in the investigation, prevention, control and disposal of potential quality and safety hazards of medical devices.

Article 59 Where medical device registrants, filers, or operating enterprises fail to take effective measures to eliminate existing medical device quality and safety risks, the drug regulatory department may conduct a responsible interview with the medical device registrant, filer, legal representative of the operating enterprise, or the person in charge of the enterprise.

Article 60 The departments responsible for drug supervision and administration at the districted municipal level shall establish and promptly update the credit files of medical device business enterprises within their jurisdiction. The credit file shall include information such as medical device business enterprise license filing, supervision and inspection results, investigation and handling of illegal acts, quality spot checks and inspections, self-inspection reports, records of bad behavior, and complaints and reports.

For medical device registrants, filers, 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 law.

Article 61 The drug administration 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 62 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 63 The drug administration department and its staff shall keep confidential the trade secrets learned during investigation and inspection.

Article 64 In supervision and inspection, drug regulatory departments and their staff shall strictly regulate fair and civilized law enforcement, strictly enforce integrity discipline, and shall not solicit or accept property, seek other benefits, or hinder the normal business activities of enterprises.

Article 65 Where laws and regulations such as the Regulations on the Supervision and Administration of Medical Devices have already provided for illegal acts in the operation of medical devices, the provisions shall be followed.

Article 66: In any of the following circumstances, corrections shall be ordered within a time limit and a fine of between 10,000 and 50,000 RMB 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 not less than 100,000 yuan but not more than 200,000 yuan shall be imposed:

(1) Class III medical device business enterprises change their business premises, business scope, business methods, and warehouse addresses without authorization;

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

Those who engage in Class III medical device business activities 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 Where the relevant requirements of the medical device operation quality management specifications are violated, the drug regulatory department shall order corrections within a time limit; 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 68 Where a medical device business enterprise fails to submit an annual self-inspection report on 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 operation enterprises, the drug regulatory department shall order correction within a time limit; 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.

Article 69 If a Class III medical device business enterprise fails to change the name, legal representative, or person in charge of the enterprise in accordance with the provisions of these Measures, the drug regulatory department shall order correction within a time limit; if they refuse to make corrections, they shall be fined between 5,000 and 30,000 yuan.

Article 70 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 71 The following terms in these Measures have the following meanings:

Medical device wholesale refers to the sale of medical devices to medical device manufacturers, medical device business enterprises, Medical device business behavior of medical device users or other units with reasonable use needs.

Medical device retail refers to the business of selling medical devices directly to consumers for personal use.

Article 72 Those engaged in online sales of medical devices shall comply with 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 was repealed at the same time.