q: what is the general idea and revision principle of the measures for the supervision and administration of medical device operation (hereinafter referred to as the "management measures")?
a: the safety and effectiveness of medical devices are related to people's lives and health, and the management process of medical devices directly affects the quality and safety of products. As one of the supporting regulations of the Regulations, the Operating Measures mainly grasp the following four points in the general idea of revision: First, implement the system of medical device registrants and filers, and strengthen their life-cycle quality and safety responsibilities. Second, strictly implement the spirit of the "streamline administration, delegate power, strengthen regulation and improve services" reform and simplify the relevant application materials and procedures. The third is to clarify the power of supervision and inspection and strengthen supervision measures. The fourth is to increase regulatory measures to solve the problem of insufficient regulatory means. Fifth, strengthen law enforcement supervision and promote fair and honest law enforcement. In order to reflect the latest regulatory concept, the new "Management Measures" adhere to the following revision principles: First, adhere to the principle of classified management. Licensing and filing are not required for the operation of Class I medical devices, and filing management is implemented for the operation of Class II medical devices. The filing of Class II medical devices whose product safety and effectiveness are not affected by the circulation process can be exempted, and licensing management is implemented for the operation of Class III medical devices. The second is to adhere to the principle of corporate responsibility. In order to highlight the responsibility of enterprise management, medical device management enterprises are required to establish a quality management system and quality control measures covering the whole process of quality management in accordance with the requirements of laws and regulations and medical device management quality management norms, and make relevant records to ensure that operating conditions and business activities continue to meet the requirements. The third is to adhere to the principle of strict supervision. Through the comprehensive use of spot checks, flight inspections, responsibility interviews, safety warnings, credit files and other systems, we will enrich regulatory measures, improve regulatory means, and promote the implementation of regulatory responsibilities. The fourth is to adhere to the principle of traceability. It is stipulated that enterprises should establish and implement the system of inspection and record of incoming goods. Enterprises engaged in the wholesale business of second and third types of medical devices and the retail business of third types of medical devices shall establish a sales record system.
q: what are the requirements of the management measures in terms of enterprise management quality management?
a: on the one hand, the management measures further strengthen the quality responsibility of enterprises. To require enterprises to engage in medical device business, they should 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 business quality management norms, and make relevant records to ensure that business conditions and business activities continue to meet the requirements. At the same time, medical device management enterprises should establish a quality management self-inspection system, conduct self-inspection according to the requirements of quality management standards for medical device management, and submit the self-inspection report of the previous year to the local drug supervision and administration department at the city and county level before March 31 each year. On the other hand, it pays more attention to the quality management of the whole process of operation. First, medical device business enterprises are required to purchase medical devices from medical device registrants, filers and business enterprises with legal qualifications, and strictly control the qualification review of procurement and sales to ensure the legal circulation of medical devices. Second, the record requirements of incoming inspection and sales are highlighted to ensure the traceability of products, and the unique identification system for medical devices should be implemented in accordance with relevant state regulations. Thirdly, the storage and transportation requirements of low-temperature and refrigerated medical devices are emphasized to ensure the transportation quality of products. The fourth is to put forward requirements for after-sales service of operating enterprises to ensure the safety of product use.
q: what measures does the operating measures take to strengthen supervision?
a: the new management measures adhere to the problem orientation, thoroughly implement the "four strictest" requirements, and strengthen supervision through the following measures: first, implement classified and hierarchical management. The pharmaceutical supervisory and administrative department shall implement classified management and dynamic adjustment according to the quality management of medical device enterprises and the risk degree of medical device products they operate. The second is to make an annual inspection plan. The departments responsible for drug supervision and administration at the municipal and county levels with districts shall formulate annual inspection plans, clarify the key points of supervision, inspection frequency and coverage, and organize their implementation. The third is to carry out extended inspection. The pharmaceutical supervisory and administrative department may, according to the needs of prevention and control of medical device quality and safety risks, conduct extended inspection on other relevant units and individuals that provide products or services for medical device business activities. The fourth is risk consultation and judgment. The pharmaceutical supervisory and administrative department shall, according to the supervision and inspection, product sampling, adverse event monitoring, complaints and reports, administrative penalties, etc., regularly carry out risk consultation and judgment, and do a good job in the investigation, prevention and control of hidden dangers of medical device quality and safety. The fifth is the construction of credit files. The municipal department in charge of drug supervision and administration at the district level shall establish and update the credit files of medical device enterprises within its jurisdiction in a timely manner.
Q: What are the differences between medical device wholesale and retail enterprises? What are the regulations for medical device registrants and filers to sell medical devices?
a: the main difference between wholesale and retail of medical devices lies in the different sales targets. Medical device wholesale refers to the medical device business behavior of selling medical devices to medical device manufacturers, medical device business enterprises, medical device users or other units with reasonable use needs. The retail of medical devices refers to the business behavior of selling medical devices directly to consumers for personal use. Medical device registrants and filers can sell their registered and filed medical devices by themselves, or they can entrust medical device business enterprises to sell them. 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.
Q: What measures does the Management Measures take to implement the spirit of the "streamline administration, delegate power, strengthen regulation and improve services" reform?
a: in order to implement the spirit of the "streamline administration, delegate power, strengthen regulation and improve services" reform, firstly, the provisions of "copy of business license" and "other supporting materials" for handling business licenses and filing were cancelled. For those who apply for the third type of business license and handle the filing procedures for the second type of business at the same time, submit the information once and complete the on-site verification regulations together. Those who have obtained the business license of Class III medical devices for the record of Class II medical devices may be exempted from submitting corresponding materials. The second is to review the application materials within the original 3 working days and adjust it to make a decision within 2 working days from the date of acceptance, thus shortening the processing time limit. Third, Class II medical devices whose product safety and effectiveness are not affected by the circulation process can be exempted from business filing. National Medical Products Administration has formulated and published 13 products. There is no need to apply for business license or business filing for medical device registrants and filers to sell their registered and filed medical devices at their residences or production addresses, as well as institutions engaged in the storage, allocation and supply of non-profit contraceptive medical devices. Fourth, if the license is lost and reissued, the requirement of publishing the loss statement in the media designated by the original issuing department is cancelled.