On October 26, the Food and Drug Administration issued the “Approval Approval Procedure for Medical Devicesâ€. According to this procedure, the Food and Drug Administration has implemented priority approval for the following medical devices: First, it diagnoses or treats rare diseases, malignant tumors and has obvious clinical advantages. Medical devices, medical devices that diagnose and treat elderly patients with multiple and multiple diseases, and currently have no effective diagnosis or treatment, medical devices that are dedicated to children and have obvious clinical advantages, clinically urgently needed, and no products of the same variety are approved for registration in China. Medical equipment; second, medical equipment listed in the national science and technology major projects or national key research and development plans. In addition, the General Administration of Food and Drug Administration will, based on various aspects and opinions, organize an expert review to determine the priority approval for “other medical devices that should be approved in priorityâ€.
For projects that are approved for priority approval, the Food and Drug Administration will speed up the review and approval of the entire process, prioritize technical review, prioritize the verification of medical device registration quality management system, prioritize administrative approval, shorten product time-to-market, and ensure corresponding results. And products can be applied to clinical use as soon as possible.
The following is the full text of the "Approval Approval Procedure for Medical Devices":
In order to ensure the clinical use of medical devices, according to the "Regulations on the Supervision and Administration of Medical Devices" (Order No. 650 of the State Council) and the "Opinions of the State Council on Reforming the Examination and Approval System for Medical Devices for Drugs" (Guo Fa [2015] No. 44) The State Food and Drug Administration has formulated the "Approval Approval Procedure for Medical Devices", which is hereby promulgated and will be implemented as of January 1, 2017.
Special announcement.
Article 1 In order to ensure the clinical use of medical devices, according to the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650) and the State Council's Opinions on Reforming the Examination and Approval System for Drug Medical Devices (Guo Fa [2015] No. 44) And the relevant regulations, the development of this procedure.
Article 2 The State Food and Drug Administration shall give priority to the application for registration of third-class and imported second- and third-class medical devices that meet one of the following conditions:
(1) Medical devices that meet one of the following conditions:
1. Diagnose or treat rare diseases with obvious clinical advantages;
2. Diagnose or treat malignant tumors with obvious clinical advantages;
3. Diagnosis or treatment of endemic and multiple diseases in the elderly, and there is currently no effective diagnosis or treatment;
4. Dedicated to children with obvious clinical advantages;
5. Clinically urgently needed, and there are no medical devices approved for registration in the same variety of products in China.
(2) Medical devices listed in the national science and technology major projects or national key research and development plans.
(3) Other medical devices that should be approved in priority.
Article 3 For the case of items (1) and (2) of Article 2 of this procedure, if the application is to be approved in priority according to this procedure, the applicant shall submit an application for priority approval to the State Food and Drug Administration.
For the second (3) item of this procedure, the State Food and Drug Administration has extensively listened to opinions and organized expert arguments to determine.
Article 4 In case of compliance with the second (1) and (2) items of Article 2 of the Procedure, the applicant shall submit the application form for priority approval of medical devices at the time of submitting the application for registration of medical devices (see Appendix 1).
For the application for priority approval of medical devices in the second item (2) of this procedure, the applicant shall also submit the relevant supporting documents for the national science and technology major projects or national key research and development plans.
Article 5 The State Food and Drug Administration General Administration of Medical Device Registration Application Acceptance Form shall conduct a formal review of the application materials for priority approval, and shall file a priority application for registration of priority application materials, and submit the application for priority approval to the State Food and Drug Administration. The Medical Device Technical Evaluation Center of the General Administration (hereinafter referred to as the Appraisal Center) conducts an audit.
Article 6 For the application for priority approval of medical devices in the second item (1) of this procedure and other medical devices that should be approved in priority, the inspection center will organize an expert demonstration review and issue an audit opinion every month. If the experts need to give priority to the examination and approval, it is proposed to give priority to the examination and approval.
For the application for priority approval of medical devices in the second item (2) of the procedure, the inspection center shall conduct an examination within 5 working days from the date of receipt of the application, and if it meets the priority approval situation, it shall be given priority for approval.
Article 7 The Applicant Center shall publish the applicant, product name and acceptance number of the priority approval project on its website, and the publicity time shall be no less than 5 working days. If there is no objection during the publicity period, the applicant will be given priority in the review process and the applicant will be informed.
Article 8 If there is any objection to the publicity project, it shall submit a written opinion to the inspection center during the publicity period and explain the reasons (see Appendix 2 for the objection list). The appraisal center shall, within 10 working days from the receipt of the objection, conduct research on the relevant opinions, and inform the applicant and the objection to the research opinions.
Article 9 If the review center fails to give priority to the examination and approval, it shall inform the applicant of the opinions and reasons for not giving priority to the examination and approval, and shall follow the routine approval procedures.
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