Views:1 Author:Site Editor Publish Time: 2021-09-06 Origin:Site
According to the official website of the Market Supervision, the 11th Affairs Conference of the Bureau reviewed the\"Measures for the Administration of Medical Device Registration and Record Management\" (hereinafter referred to as two\"Measures\"), It is implemented on October 1, 2021.
Medical instruments are related to the people's health and safety. On February 9, 2021, the New\"Medical Device Supervision and Administration Regulations\" (hereinafter referred to as\"Ordinance\") officially announced. In order to implement the new\"Regulations\", implement the reform requirements of medical device review examination and approval system, establish a more scientific medical device supervision and management system, strengthen medical equipment registration management, the State Food and Drug Administration organized the original\"medical device registration management method\"\"in vitro Diagnostic Reagent Registration Management Measures for Revision.
During the revision, the Market Supervision Bureau, the State Food and Drug Administration has held a symposium, field research, special discussions, and widely listened to observations such as local regulatory authorities, industry associations, enterprises and legal and technical experts. Two\"Measures\" implementation \"four 蕞 \ \" requirements, refine the supervision system, encourage innovation, strengthen the subject responsibility, improve supervision requirements, improve the regulatory scientific, and enrich the regulatory means to improve supervision efficiency.
The revised\"Measures for the Administration of Medical Device Registration and Record\", 124,\"Measures for the Registration and Recording of Inc., Type 10 Chapter 10, the revised focus of the revised\" include: First, the medical device registrant system, clinical The reform results of the deployment of the State Council deployment of the trials, the expansion clinical trial, the conditions for approval system, etc. Summary in recent years to encourage new medical equipment to create new experience, and add special registration procedures to the list of special registration procedures, stipulate innovative product registration procedures, priority registration procedures; summarize in recent years, especially new crown pneumonia epidemic prevention and control work, medical equipment The experience of emergency approval, stipulates the emergency registration procedures, clarifies the scope of the programs, support policies.
The second is to implement \"four 蕞蕞 \" requirements. Clarify the duties of the State Food and Drug Administration, the technical institution, the Provincial Food and Drug Administration, and implement the supervision responsibility of the supervision departments at all levels. Clear extension inspection requirements, improve clinical trial risk control and clinical trial site inspection provisions, and establish a responsibility interview system. At the same time, strengthen the registered personnel of medical equipment, the principal responsibility of the filing, and demand the quality management of the full life cycle of medical equipment, the safety, effectiveness and quality controllability of medical devices in the whole process of medical equipment. Take responsibility.
The third is to implement \"discharge service \" reform requirements. Simplify the requirements of registration of the registered documents such as overseas listed proofs, inspection reports, no longer need to submit foreign listing documents, encourage innovative products to be listed in my country as soon as possible; adjust the second type, third types of medical Device Inspection Report requirements, explicitly registered applicants can submit self-test reports.
The fourth is to optimize scientific high-efficiency review approval procedures. The relevant requirements of medical device clinical evaluation are adjusted, which clearly exempts the situation of submitting clinical evaluation materials and the requirements for the presence of clinical trial examination and approval. Implementing the responsibility of the medical device registration record management, strengthen the contract, review, review, and system verification, etc., and focus on improving the working efficiency of the registration of medical devices.
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