Article 2 The business activities of medical devices and their supervision and management within the territory of People's Republic of China (PRC) shall abide by these Measures.
Article 3 When engaging in business activities of medical devices, it shall abide by the requirements of laws, regulations, rules, mandatory standards, quality management norms of medical device business, and ensure the truthfulness, accuracy, completeness and traceability of information in the business process of medical devices.
Medical device registrants and filers can sell medical devices by themselves, or they can entrust medical device business enterprises to sell their registered and filed medical devices.
Article 4 Medical devices shall be classified and managed according to their risk degree.
The operation of Class III medical devices shall be subject to licensing management, while the operation of Class II medical devices shall be subject to filing management, and the operation of Class I medical devices shall not require licensing and filing.
Article 5 The State Medical Device Supervision and Administration Bureau shall be in charge of the supervision and administration of medical device operation throughout the country.
The pharmaceutical supervisory and administrative 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 areas.
The drug supervision and administration departments at the city and county level divided into districts shall be responsible for the supervision and administration of the operation of medical devices within their respective administrative areas.
Article 6 Professional technical institutions such as medical device inspection, testing, monitoring and evaluation established or designated by the pharmaceutical supervisory and administrative department according to 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 Administration of Medical Devices shall strengthen the informatization construction of medical device supervision and management, and improve the online government service level.
The pharmaceutical supervisory and administrative 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 within their respective administrative areas, and promote the information sharing of medical device operation supervision and management in accordance with the requirements of national medical device management.
Article 8 The pharmaceutical supervisory and administrative department shall promptly disclose the business license and filing information of medical devices, as well as the results of supervision and inspection and administrative punishment, so as to facilitate public inquiries and accept social supervision.
Chapter II Management of Business License and Filing
Article 9 To engage in business activities of medical devices, the following conditions shall be met:
(a) there are quality management institutions or quality management personnel suitable for the business scope and scale, and the quality management personnel shall have relevant professional qualifications or titles;
(2) A business place suitable for its business scope and scale;
(3) Storage conditions suitable for the business scope and scale;
(4) A quality management system suitable for the medical devices operated;
(five) 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 third-class medical devices should also have a computer information management system that meets the requirements of the quality management system of medical device operation to ensure the traceability of the products they operate. Encourage enterprises engaged in Class I and Class II medical devices to establish computer information management systems that meet the requirements of medical device quality management systems.
Article 10 An enterprise engaged in the operation of Class III medical devices shall apply to the local municipal drug supervision and administration department and submit the following materials:
(a) the legal representative (person in charge of the enterprise) and the relevant materials of the identity certificate, education or professional title of the person in charge of quality;
(two) the organization and department of the enterprise;
(3) The business scope and mode of operation of medical devices;
(four) the geographical location map, floor plan, certificate of housing property rights or a copy of the lease agreement of the business premises and warehouses;
(five) the main business facilities and equipment directory;
(six) management quality management system, working procedures and other documents;
(7) Basic information management system;
(8) the authorization document of the agent.
The applicant for the medical device business license shall ensure that the materials submitted are legal, true, accurate, complete and traceable.
Article 11 After receiving the application, the municipal drug supervision and administration department shall deal with it according to the following circumstances:
(a) the application matters belong to the scope of functions and powers of the administrative organ, and the application materials are complete and conform to the statutory form, and 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 five working days. Fails to inform, since the date of receipt of the application materials is accepted;
(four) 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 municipal drug supervision and administration department accepts or refuses to accept the application for medical device business license, it shall issue a notice of acceptance or rejection with the special seal of the administrative organ and the date.
Article 12 The pharmaceutical supervisory and administrative department shall announce to the public and hold a hearing on matters that should be heard in the implementation of administrative license as stipulated by laws, regulations and rules, or other major administrative licensing matters involving public interests that the pharmaceutical supervisory and administrative department deems necessary. If the application for medical device business license directly involves the vital interests between the applicant and others, the pharmaceutical supervisory and administrative department shall inform the applicant and interested parties of the right to request a hearing before making a decision on administrative license.
Article 13 After accepting the application for business license, the municipal drug supervision and administration department with districts shall examine the application materials, conduct on-site verification according to the requirements of the Quality Management Standard for Medical Device Operation when necessary, and make a decision within 20 working days from the date of acceptance. Need rectification, rectification time is not included in the audit time limit.
In line with the prescribed conditions, make a written decision to grant the license, and issue a medical device business license within 10 working days; Do not meet the prescribed conditions, make a written decision not to license, and explain the reasons.
Article 14 The validity period of the Medical Device Business License is five years, and the license number, enterprise name, unified social credit code, legal representative, person in charge of the enterprise, domicile, business place, business mode, business scope, warehouse address, issuing department, issuing date and validity period shall be clearly stated.
The Medical Device Business License is uniformly printed by the State Medical Device Administration and printed by the municipal drug supervision and administration department with districts.
The electronic certificate of Medical Device Business License produced by the drug supervision and administration department has the same legal effect as the paper certificate.
Fifteenth medical device business license changes, it shall apply to the original license issuing department for the change of medical device business license, and submit the relevant materials related to the change as stipulated in Article 10 of these Measures. Where the business place, business mode, business scope and warehouse address are changed, the pharmaceutical supervisory and administrative department shall make a decision on whether to approve the change within 20 working days from the date of acceptance. When necessary, conduct on-site verification in accordance with the requirements of quality management standards for medical device operation.
Need rectification, rectification time is not included in the audit time limit. If no change is made, the reasons shall be explained in writing and the applicant shall be informed. Where other matters are changed, the pharmaceutical supervisory and administrative department shall make changes on the spot.
The serial number and validity period of the changed Medical Device Business License remain unchanged.
Sixteenth medical device business license expires and needs to be extended, the medical device business enterprise shall apply for an extension within 90 working days to 30 working days before the expiration of the validity period. If the application for extension is not submitted within the time limit, the application for extension will no longer be accepted.
The original issuing department shall review the application for extension in accordance with the provisions of Article 13 of these Measures, conduct on-site verification when necessary, and make a decision on whether to grant the extension before the expiration of the validity period of the Medical Device Business License.
Upon examination, if it meets the prescribed conditions, it is allowed to be extended, and the number of the Medical Device Business License after extension remains unchanged. Do not meet the prescribed conditions, shall be ordered to make rectification within a time limit; If the rectification still does not meet the prescribed conditions, it shall not be continued, and the reasons shall be explained in writing. If no decision is made within the time limit, it shall be deemed as an extension.
If the approval time for renewal of the license is within the validity period of the original license, the starting date for renewal is the day after the expiration of the validity period of the original license; If the approval time is not within the validity period of the original license, the start date of the extension is the approval date of the extension license.
Article 17 Where a business enterprise establishes a warehouse across a city divided into districts, the issuing department or filing department of the medical device business license shall notify the municipal drug supervision and administration department where the warehouse is located.
Article 18 Where an operating enterprise newly establishes an independent business place, it shall separately apply for the Medical Device Business License or put it on record according to law.
Nineteenth medical device business license is lost, it shall apply to the original issuing department for a replacement. The original license issuing department shall timely renew the License for Medical Device Business Enterprises, and the serial number and validity period of the renewed License for Medical Device Business Enterprises are consistent with the original license.
Twentieth in any of the following circumstances, the original issuing department shall cancel the business license of medical devices according to law and make an announcement:
(a) take the initiative to apply for cancellation;
(two) the expiration of the validity period has not been extended;
(3) The qualification of market subject is terminated according to law;
(4) The medical device business license is revoked or revoked according to law;
(five) other circumstances in which the administrative license shall be cancelled according to laws and regulations.
Article 21 Where an operating enterprise engages in the operation of Class II medical devices, it shall file a record with the local municipal drug supervision and administration department and submit materials that meet the requirements of Article 10 of these Measures (except for Item 7), that is, the business record is complete and the business record number is obtained.
The filer of a medical device business enterprise shall ensure that the information submitted is legal, true, accurate, complete and traceable.
Twenty-second when necessary, the municipal drug supervision and administration department of the district shall, within 3 months from the date of filing, conduct on-site inspection of the submitted materials and the implementation of the quality management standards for medical device operation.
On-site inspection found that the submitted materials do not conform to or do not meet the requirements of medical device management quality management standards, and shall be ordered to make corrections within a time limit; If the product cannot be guaranteed to be safe and effective, it shall be cancelled for the record and announced to the public.
Article 23 Those who apply for the business license of Class III medical devices and file the business license of Class II medical devices at the same time, or who have obtained the business license of Class III medical devices and filed the business license of Class II medical devices, may be exempted from submitting the corresponding materials.
Article 24 Where the business place, mode of operation, business scope and warehouse address of a medical device trading enterprise of Category II change, it shall make timely changes for the record. When necessary, the municipal drug supervision and administration department with districts shall conduct on-site inspection. On-site inspection does not meet the requirements of medical device management quality management norms, and shall be ordered to make corrections within a time limit; If the product cannot be guaranteed to be safe and effective, it shall be cancelled for the record and announced 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 filing by enterprises. The specific product catalogue shall be formulated, adjusted and published by the State Administration of Pharmaceutical Products.
Twenty-sixth institutions engaged in the storage, allocation and supply of non-profit contraceptive medical devices shall abide by the relevant regulations and do not need to apply for medical device business license or filing.
Twenty-seventh medical device registrants and filers who sell their registered medical devices at their residences or production addresses do not need to apply for medical device business license or filing, but they should meet the prescribed business conditions; Where medical devices are stored and sold in different places, the business license or filing of medical devices shall be handled in accordance with the regulations.
Article 28 No unit or individual may forge, alter, buy, sell, lease or lend the business license of medical devices.
Chapter III Business Quality Management
Article 29 To engage in medical device business, a quality management system and quality control measures covering the whole process of procurement, acceptance, storage, sales, transportation and after-sales service shall be established in accordance with the requirements of laws, regulations and quality management standards for medical device business, and relevant records shall be made to ensure that business conditions and business activities continue to meet the requirements.
Article 30 A medical device trading enterprise shall establish and implement a product traceability system to ensure product traceability.
Medical device trading enterprises shall implement the unique identification system for medical devices in accordance with relevant state regulations.
Thirty-first medical device business enterprises should purchase medical devices from medical device registrants, filers and business enterprises with legal qualifications.
Article 32 A medical device trading enterprise shall establish an inspection record system. When purchasing medical devices, it shall inspect the qualifications of the suppliers, as well as the registration certificate, filing materials and qualification certificates of medical devices. Incoming inspection records shall be true, accurate, complete and traceable. Incoming inspection records include:
(1) Name, model, specification and quantity of medical devices;
(2) The registration certificate number or record number of the medical device;
(3) Names, production license numbers or record numbers of medical device registrants, filers and entrusted manufacturing enterprises;
(4) Production batch number or serial number, use period or expiration date, purchase date, etc. 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 of the medical device; If there is no validity period, it shall not be less than 5 years. The incoming inspection records of implantable medical devices shall be kept permanently.
Article 33 A medical device trading enterprise shall take effective measures to ensure that the transportation and storage of medical devices meet the requirements of the instructions or labels of medical devices, and make corresponding records.
If there are special requirements for environmental conditions such as temperature and humidity, corresponding measures should be taken to ensure the safety and effectiveness of medical devices.
Article 34 Where medical device registrants, filers and business enterprises entrust other units to transport and store medical devices, they shall evaluate the quality assurance ability of the entrusted party in transporting and storing medical devices, and sign an entrustment agreement with them to clarify the quality responsibility in the process of transportation and storage, so as to ensure the quality and safety in the process of transportation and storage.
Article 35 Whoever provides transportation and storage services specifically for medical device registrants, filers and business enterprises shall sign a written agreement with the entrusting party to clarify the rights, obligations and quality responsibilities of both parties, have equipment and facilities suitable for the transportation and storage conditions and scale of products, and have an information management platform and technical means that can be traced back to the whole process of product management and quality management with the entrusting party.
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.
Thirty-seventh medical device registrants, filers and business enterprises should strengthen the training and management of sales personnel, and bear legal responsibility for the sales personnel's purchase and sale of medical devices in the name of the enterprise.
Article 38 An operating enterprise 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 should be true, accurate, complete and traceable. Sales records include:
(1) Name, model, specification, registration certificate number or record 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) Names, production license numbers or record numbers of medical device registrants, filers and entrusted manufacturing enterprises.
The sales records of enterprises engaged in the wholesale business of Class II and Class III medical devices shall also include the name, address, contact information, relevant license document number or filing number of the purchaser.
Sales records shall be kept for 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. The sales records of implantable medical devices shall be kept permanently.
Article 39 A medical device trading enterprise shall provide after-sales service. Where it is agreed that suppliers or other organizations will provide after-sales service, the operating enterprise shall strengthen management to ensure the safety of after-sales use of medical devices.
Article 40 Medical device trading enterprises shall be equipped with full-time or part-time personnel to be responsible for after-sales management. For the quality problems complained by customers, they shall find out the reasons, take effective measures to deal with and feedback them in time, make records, and notify medical device registrants, filers and production and operation enterprises in time when necessary.
Article 41 A medical device trading enterprise shall assist the medical device registrant and the applicant to monitor the adverse events of the medical devices it operates, and report to the medical device adverse event monitoring technical institution in accordance with the provisions of the State on the administration of medical devices.
Article 42 If a medical device trading enterprise finds that the medical devices it operates do not meet the mandatory standards, the technical requirements of the registered or filed products or have other defects, it shall immediately stop operating, notify the relevant units such as the medical device registrant and the filer, and record the situation of stopping operating and notifying. Medical device registrants and filers shall recall them immediately if they think it is necessary.