1. What is the background of the revision of the "Supervision and Administration of Medical Device Production" (hereinafter referred to as "the Measures") and the main ideas of the revision?
Since 2015, the State Council's Opinions on Reforming the Review and Approval System of Pharmaceuticals and Medical Devices (Guo Fa [2015] No. 44), the General Office of the CPC Central Committee and the General Office of the State Council's Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Pharmaceuticals and Medical Devices (Office of the Word [2017] No. 42) and other important documents have been released, requiring in-depth promotion of the reform of the review and approval of medical devices and encouraging innovation at the same time. On December 21, 2020, the State Council executive meeting considered and adopted the newly revised Regulations on Supervision and Administration of Medical Devices (hereinafter referred to as "the Regulations") in the form of regulations to The Regulations will consolidate the achievements of reform, improve the regulatory system and increase the penalties for violations.
In order to implement the "four strictest" requirements, carry out the spirit of the Regulations, dovetail with the newly revised Administrative Measures for Registration and Filing of Medical Devices and Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents in 2021, and meet the needs of industrial development and regulatory practice, the State Drug Administration, on the basis of in-depth investigation and extensive consultation, conducted a comprehensive revision of the existing Measures. The Measures have been comprehensively revised.
The general idea of the Measures is to grasp the following points: firstly, to implement the latest requirements of the Regulations on the supervision of medical device production, to fully implement the medical device registrar and filer system, and to strictly implement the main responsibility of enterprises; secondly, to implement the spirit of the reform of "decentralization and administration", and to simplify the relevant declaration information and procedural requirements; thirdly, to enrich and improve Thirdly, it enriches and improves the regulatory means, improves operability and solves the practical problems of supervision; Fourthly, it implements the "four strictest" requirements, strengthens risk management and increases the penalties for violations.
2. What are the initiatives of the Measures in promoting the medical device registrar system and implementing the spirit of "administrative and service" reform?
In the implementation of the medical device registrar system, one is to change the status quo that medical device manufacturers need to apply for production licenses only with their own registration certificates, allowing entrusted manufacturers to apply for production licenses with the registrar's registration certificate; the second is to remove the restriction that entrusted production filings and the same product can only be entrusted to one enterprise for the same period, deleting the chapter on "entrusted Thirdly, the responsibilities and obligations of both the registrant and the entrusted manufacturer were clarified, stipulating that the registrant is responsible for the quality and safety of medical devices and the entrusted manufacturer is responsible for the production behavior, requiring both parties to sign a quality agreement for entrusted production, specifying that the entrusted manufacturer is responsible for production release and the registrant is responsible for Fourth, to strengthen the supervision of the registrant, clarify the registrant's inter-provincial entrusted production situation of inspection responsibilities, inspection methods, results disposal, investigation and evidence collection and other regulatory requirements.
In the spirit of implementing the reform of "management and service", one is to abolish the requirement of submitting "copies of business license" and other materials for applying for medical device manufacturing license and filing for Class I medical device manufacturing in the existing Measures, and to clarify that materials that can be verified through networking are not required to be provided by the applicant. Second, the medical device production license application review time limit from 30 working days to 20 working days; Third, the provisions of the medical device filer to produce the first-class medical devices, can be in the product for the record along with the production for the record.
3. what are the main aspects of the "Measures" to improve the means of supervision of medical device production?
The "Measures" in the existing medical device production licensing and filing, supervision and inspection, responsibility interviews and other regulatory methods and approaches, based on four aspects to further enrich the improvement of regulatory tools.
First, the establishment of a medical device reporting system. It provides for four forms of reporting: annual reports, reports on the variety of products manufactured, reports on changes in production conditions and reports on re-production, so that the regulatory authorities can keep abreast of the production status of enterprises and take targeted regulatory measures.
Second, to further improve the ways and means of supervision and inspection. It clarifies various forms of supervision and inspection, such as supervision and inspection, key inspection, follow-up inspection, causal inspection, and special inspection, and makes specific provisions on the contents and methods of causal inspection and follow-up inspection.
Third, refine and clarify the information disclosure and responsibility interview system. Drug supervision and management departments in accordance with the law and timely disclosure of medical device production licensing, filing, supervision and inspection, administrative penalties, and other information to facilitate public enquiry, accepting social supervision. Medical device registrants, filers, entrusted manufacturing enterprises on the existence of medical device quality and safety risks, did not take effective measures to eliminate, drug supervision and management departments can be medical device registrants, filers, entrusted manufacturing enterprises, the legal representative or the person in charge of the enterprise responsibility interview.
Fourth, to strengthen the medical device production supervision information technology construction work. State Drug Administration to strengthen medical device production supervision and management of information technology construction, improve the level of online government services. Provinces, autonomous regions, municipalities directly under the Central Drug Administration is responsible for the administrative region of medical device production supervision and management of information technology construction and management, in accordance with the requirements of the State Drug Administration to coordinate the promotion of medical device production supervision and management information sharing.
4. how to strengthen risk control and disciplinary action for violations of the law, the specific increase in the penalty provisions?
In strengthening risk prevention and control and disciplinary action for violations, one is in the "Regulations" Article 72 emergency control measures on the basis of further clarification of the production of medical devices to cause harm to humans or evidence that may endanger human health, drug supervision and management departments can take to suspend the production, import, operation, use of emergency control measures; second is the provision of imported medical devices registrant, filer, the agents refuse, obstruct, delay, evade the State Drug Administration organization of overseas inspection, resulting in the inspection work cannot be carried out, cannot confirm the effective operation of the quality management system, belong to the evidence that may endanger human health situation, can be handled in accordance with the provisions of the Regulations; Third, the implementation of the requirements of the Regulations, increase the penalties for violations, and according to the needs of regulatory work to increase the corresponding penalties Fourthly, to clarify the credit file and disciplinary system for breach of trust, requiring the establishment of a credit file and the possibility of imposing disciplinary sanctions for breach of trust according to the actual situation.
In addition to the legal responsibilities stipulated in the Regulations, the Measures add two new penalty clauses, one is that for medical device manufacturers who fail to report the situation of the product varieties produced and related information in accordance with the Measures, or who cease production for more than one year continuously and have no similar products in production, and fail to conduct the necessary verification and confirmation when re-producing and report to the local drug supervision and management department, the drug supervision and management department shall, in accordance with its Secondly, for those who fail to change the registration of medical device production license in accordance with the provisions of the Measures, or fail to organize the assignment of codes, data uploading and maintenance updates in accordance with the relevant requirements of the national implementation of the unique identification of medical devices, the drug supervision and management department shall, in accordance with its duties, order a deadline for rectification, and if it refuses to do so, impose a fine of 10,000 yuan or more than 50,000 yuan. If the circumstances are serious, a fine of more than 50,000 yuan and less than 100,000 yuan shall be imposed.
5. How should medical device registrants and filers commission production and how to release products?
Medical device registrants and filers entrusting production should assess the quality assurance capability and risk management capability of the entrusted party, sign quality agreements as well as entrustment agreements with them in accordance with the requirements of the quality agreement guidelines for entrusted production formulated by the State Drug Administration, and supervise the entrusted party to fulfill the obligations agreed in the relevant agreements; entrusted production enterprises should comply with laws, regulations, rules, medical device production quality management specifications, The entrusted production enterprise shall organize production in accordance with laws, regulations, rules and regulations, medical device production quality management norms, mandatory standards, product technical requirements, entrusted production quality agreement and other requirements, be responsible for the production behavior, and accept the supervision of medical device registrants and filers.
Entrusted production enterprises shall report to the original production license or production record department to increase the production of product varieties, and provide the commissioner, entrusted production products, entrusted period and other information; increase production products involving changes in production conditions, which may affect product safety, effective, should be reported to the original production license department 30 working days before the increase in production products, the original production license department shall promptly carry out on-site verification . Is a change in licensing matters, should be in accordance with the provisions of the relevant licensing changes.
Medical device registrant, the filer shall be responsible for the product listing release, the establishment of product listing release procedures, clear release criteria, conditions, and medical device production process records and quality inspection results for review, meet the standards and conditions, by the authorized release personnel to sign before listing. In the case of entrusted production, the medical device registrant or filer shall also review the production release documents of the entrusted production enterprise. The entrusted manufacturer shall establish production release procedures, clarify the criteria and conditions for production release, and confirm that the standards and conditions are met before leaving the factory. Does not meet the laws, regulations, rules, mandatory standards, and the technical requirements of the registered or filed products, shall not be released from the factory, and listed. Medical device registrant, the filer shall not be entrusted to the manufacturing enterprises for listing release.
6. how should medical device registrants, filers and entrusted manufacturers implement the reporting system?
In order to further implement the main responsibility of medical device registrants, filers and entrusted manufacturers, the "Measures" establish a medical device reporting system and provide for the corresponding legal responsibilities. Medical device registrants, filers, entrusted manufacturers should be in accordance with the provisions of the implementation of the medical device reporting system.
First, the implementation of the self-reporting system. Medical device registrants, filers, entrusted manufacturing enterprises shall conduct annual self-inspection of the operation of the quality management system, in accordance with the guidelines for the preparation of the annual self-inspection report on the quality management system of medical device production, and submit the self-inspection report to the local drug supervision and management department before March 31 of the following year. Imported medical device registrants, filers by their agents to the agent's location in the provinces, autonomous regions, municipalities directly under the Central Drug Administration to submit a self-inspection report.
Second, the implementation of the production of product variety reporting system. Medical device manufacturers should report to the drug supervision and management departments on the varieties of products produced. Increase in the production of product varieties, should be reported to the original production license or production record department, involving entrusted production, should also provide the entrusted party, entrusted production products, entrusted period, and other information. Medical device manufacturers to increase the production of products involving changes in production conditions, which may affect product safety, effective, should be increased in the production of products 30 working days before the original production license department report, the original production license department shall promptly carry out on-site verification. Is a change in licensing matters, should be in accordance with the provisions of the relevant licensing changes.
Third, the implementation of the reporting system for changes in production conditions. Medical device registrants, filers, entrusted production enterprises of production conditions change, no longer meet the requirements of the medical device quality management system, should immediately take corrective measures; may affect the safety of medical devices, effective, should immediately stop production activities, and to the original production license or production record department report. The entrusted manufacturer shall promptly inform the medical device registrant or recorder of the changes.
Fourth, the implementation of the re-production reporting system. Medical device manufacturers to stop production for more than one year in a row and no similar products in production, the re-production, should be necessary to verify and confirm, and report in writing to the drug supervision and management departments. May affect the quality and safety, drug supervision and management departments can organize verification as needed.
Content source: State Medical Products Administration
