The new regulations on the production of medical devices will come into force on May 1: strengthen risk control and punish illegal acts
2022-03-23
According to the official website of the State Food and drug administration, the State Administration of Market Supervision recently issued the revised Measures for the supervision and administration of the production of medical devices (hereinafter referred to as the measures), which will come into force on May 1, 2022. It is reported that the measures implement the requirements of the regulations on the supervision and administration of medical devices (hereinafter referred to as the regulations), increase the punishment of illegal acts, and increase the corresponding punishment requirements according to the needs of supervision. At the same time, clarify the credit file and dishonesty punishment system, require the establishment of credit file, and implement dishonesty punishment according to the actual situation. The relevant person in charge of the State Food and Drug Administration said that the first step of the measures is to fully implement the medical device registrant filing system and strictly implement the main responsibility of enterprises; Second, implement the reform spirit of "release, control and service" and simplify the requirements of relevant application materials and procedures; Third, enrich and improve the supervision means, improve the operability and solve the practical problems of supervision; Fourth, implement the "four strictest" requirements, strengthen risk management and strengthen the punishment of illegal acts. Establish medical device reporting system In order to further implement the main responsibilities of medical device registrants, recorders and entrusted production enterprises, the measures establish a medical device reporting system and stipulate corresponding legal responsibilities. According to the relevant person in charge of the State Food and drug administration, the first is to implement the self-examination report system. Medical device registrants, recorders and entrusted manufacturing enterprises shall conduct self-examination on the operation of the quality management system every year, prepare self-examination reports in accordance with the requirements of the guidelines for the preparation of annual self-examination reports of medical device production quality management system, and submit self-examination reports to the local drug regulatory department before March 31 of the next year. The registrants and recorders of imported medical devices shall submit a self inspection report to the drug regulatory department of the province, autonomous region or municipality directly under the central government where the agent is located. Second, implement the product variety reporting system. A medical device manufacturer shall report the variety of products it produces to the drug regulatory department. Third, implement the reporting system for changes in production conditions. If the production conditions of the medical device registrant, filer and entrusted manufacturing enterprise change and no longer meet the requirements of the medical device quality management system, rectification measures shall be taken immediately. Fourth, implement the re production report system. If a medical device manufacturer has stopped production for more than one year and no similar products are in production, it shall carry out necessary verification and confirmation when re producing, and report it to the drug regulatory department in writing. If it may affect quality and safety, the drug regulatory department may organize verification as needed. We will strengthen risk control and discipline violations How to strengthen risk control and punishment of illegal acts? What punishment clauses have been added to the measures? In terms of strengthening risk prevention and control and punishing illegal acts, the relevant person in charge of the State Food and Drug Administration introduced that on the basis of the emergency control measures in Article 72 of the regulations, the measures further clarify that if the produced medical devices cause harm to human body or there is evidence that they may endanger human health, the drug regulatory department can take emergency control measures to suspend production, import, operation and use. At the same time, it is stipulated that the registrants, recorders and agents of imported medical devices refuse, hinder, delay or evade the overseas inspection organized by the State Drug Administration, resulting in the failure of the inspection work and the failure to confirm the effective operation of the quality management system. If there is evidence that they may endanger human health, they can be dealt with in accordance with the regulations. In addition to the legal responsibilities stipulated in the regulations, the measures add two punishment clauses. One is for medical device manufacturers who fail to report the variety and relevant information of products produced in accordance with the measures, or who have stopped production for more than one year and no similar products are in production, and fail to carry out necessary verification and confirmation and report to the local drug regulatory department during re production, The drug regulatory department shall give a warning according to its duties and impose a fine of not less than 10000 yuan but not more than 50000 yuan. Second, for those who fail to change the registration items of the production license of medical devices in accordance with the provisions of the measures, or who fail to organize the code assignment, data upload, maintenance and update in accordance with the relevant requirements of the state for the implementation of the unique identification of medical devices, the drug regulatory department shall order them to make corrections within a time limit according to their duties. If they refuse to make corrections, they shall be fined not less than 10000 yuan but not more than 50000 yuan. If the circumstances are serious, they shall be fined not less than 50000 yuan but not more than 100000 yuan. Simplify the requirements of relevant declaration materials and procedures In terms of the implementation of the medical device registrant system, the relevant person in charge of the State Food and Drug Administration introduced that the first is to change the current situation that medical device manufacturers need to apply for production licenses with their own registration certificates, and allow entrusted production enterprises to apply for production licenses with the registrant's registration certificates. Second, the restriction that only one enterprise can be entrusted with the production of the same product in the same period has been abolished, the chapter of "entrusted production management" has been deleted, and the relevant requirements have been incorporated into the quality management system for unified management. Third, it defines the responsibilities and obligations of both the registrant and the entrusted production enterprise, stipulates that the registrant is responsible for the quality and safety of medical devices, and the entrusted production enterprise is responsible for the production behavior, requires both parties to sign the entrusted production quality agreement, and specifies that the entrusted production enterprise is responsible for the production release and the registrant is responsible for the listing release. Fourth, strengthen the supervision of the registrant, and clarify the inspection responsibilities, inspection methods, result disposal, investigation and evidence collection and other regulatory requirements of the registrant in the case of cross provincial entrusted production. In terms of implementing the reform spirit of "release, management and service", first, the provisions in the current measures on the need to submit "copy of business license" and other materials for applying for medical device production license and handling class I medical device production record have been abolished, and it is clear that the materials that can pass online verification do not need to be provided by the applicant; Second, the time limit for the review of medical device production license application was adjusted from 30 working days to 20 working days; Third, it is stipulated that if the medical device recorder produces class I medical devices by himself, he can go through the production filing together with the product filing. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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