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Medical device emergency approval procedure (full text)
* Articles are effective in preventing, timely controlling and eliminating the hazards of public health emergencies, ensuring that medical devices needed for emergency public health emergencies are completed and approved as soon as possible. According to the State Council's Emergency Regulations on Public Health Emergencies, Medical Device Supervision and Management This Regulation is established by regulations and regulations such as the Regulations and the Measures for the Administration of Medical Device Registration.
Article 2: When there is a threat of public health emergencies, and after a public health emergency occurs, the food and drug supervision and administration department shall, in accordance with the principles of unified command, early intervention, rapid and efficient, and scientific examination and approval, emergency treatment of public health emergencies. Medical equipment is required to implement emergency approval.
Article 3 The State Food and Drug Administration shall decide the time for starting and terminating this procedure based on the circumstances and development of public health emergencies.
After the commencement of this procedure, all levels of food and drug supervision and management departments and related technical institutions shall carry out registration tests, quality management system assessment, technical review and administrative examination and approval of relevant medical devices according to their respective functions and procedures.
Article 4 This procedure is applicable to the emergency response of public health emergencies, and there is no similar product listed in China, or although similar products have been listed in China, the supply of products cannot meet the emergency treatment needs of public health emergencies. And the approval of medical devices confirmed by the State Food and Drug Administration.
Article 5 In case of application for emergency examination and approval of medical devices, the applicant shall inform the corresponding food and drug supervision and administration department in advance of the conditions required for product emergency and product development. The food and drug supervision and administration departments at all levels shall promptly understand the development of relevant medical devices, take early interventions as necessary, conduct technical assessments of the products to be declared, and promptly guide the production enterprises to carry out relevant declaration work.
Article 6 For medical devices applying for emergency examination and approval, the applicant shall submit the summary information and relevant instructions to the State Food and Drug Administration.
The State Food and Drug Administration has established a special expert group to evaluate and audit medical devices for emergency approval. Within 3 days, confirm whether the product is subject to contingency approval, define the product management category, and notify the applicant of the result.
Article 7 For medical equipment of type * that has been confirmed by the State Food and Drug Administration for emergency examination and approval, the production enterprise shall inform the local food and drug administration of the province, autonomous region or municipality directly under the Central Government in accordance with the relevant provisions of the Measures for the Supervision and Administration of the Production of Medical Devices. The food and drug supervision administrations of provinces, autonomous regions and municipalities directly under the Central Government shall sign and collect them in a timely manner.
For the second and third types of medical devices confirmed by the State Food and Drug Administration for emergency approval, the food and drug administrations of the provinces, autonomous regions, and municipalities directly under the Central Government where the production enterprises are located shall receive the license of the medical device manufacturing enterprises of the relevant medical device manufacturers. After the application for the application or change of the certificate, the decision on whether to issue or change the "Medical Device Manufacturing Enterprise License" shall be made within 5 days in accordance with the relevant provisions of the "Measures for the Supervision and Administration of Medical Device Production".
Article 8 For medical devices that have been confirmed by the State Food and Drug Administration for emergency approval (hereinafter referred to as emergency approval medical devices), the relevant medical device testing institutions shall organize the medical device registration test within 24 hours after receiving the samples, and issue them in time. Test Report.
Article 9 For emergency examination and approval of medical devices, the corresponding food and drug supervision and administration department shall, after receiving the application for examination of the quality management system of the production enterprise, organize the on-site assessment work within 2 days and issue a quality management system assessment report in a timely manner.
Article 10 For the emergency examination and approval of medical devices, after the corresponding medical device registration and acceptance department accepts the application, the registration application project shall be marked as “emergency approvalâ€, and the special person shall be responsible for the circulation of the registration application materials on the day of acceptance.
Article 11 After the acceptance of the application for registration of medical equipment for emergency approval, the food and drug supervision and administration department shall complete the technical review and administrative examination and approval within 5 days.
Article 12 After the second type of application for registration of medical equipment for emergency examination and approval is accepted, the food and drug supervision and administration department shall complete the technical review within 5 days; after the completion of the technical review, the administrative examination and approval shall be completed within 3 days.
Article 13 After the application for registration of the third type of emergency examination and approval medical device is accepted, the food and drug supervision and administration department shall complete the technical review within 10 days; after the completion of the technical review, the administrative examination and approval shall be completed within 3 days.
Article 14 This procedure shall be implemented as of the date of promulgation.
State Food and Drug Administration issues medical device emergency approval procedures
In order to effectively prevent, timely control and eliminate the hazards of public health emergencies, and ensure that the medical equipment required for emergency public health emergencies complete registration and approval as soon as possible, the State Food and Drug Administration has formulated the "medical equipment emergency approval procedures", and Issued a few days ago. A total of 14 "Approval Procedures" will be implemented as of the date of promulgation.