CFDA releases medical device priority approval draft
In order to ensure the clinical use of medical devices, in accordance with 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 Device Registration Department of the Food and Drug Administration has drafted the "Approval Procedure for Medical Device Priority" (see the attachment for comments). Please ask your organization to organize the research and give feedback before July 20, 2016.
e-mail:. When sending an email, please indicate "Priority Approval Process Opinion" at the subject of the email.
Letter: Building No. 2, No. 26, Xuanwumen West Street, Xicheng District, Beijing, Department of Equipment Registration, Food and Drug Administration, Zip Code: 100053.
Other units or individuals may submit feedback via the above email or letter, and the deadline for comments is the same as above.
Department of Food and Drug Administration, Equipment Registration Division
June 20, 2016
Attached to the medical device priority approval process (draft for comments)
Article 1 In order to ensure the clinical use of medical devices, in accordance with 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 Medical Devices for Drugs (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 listed in the national science and technology major projects or national key research and development plans.
(2) Medical devices that meet one of the following conditions:
1. Diagnose or treat rare diseases with obvious clinical advantages;
2. Diagnosis or treatment of 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. Diagnosis or treatment of children with unique and multiple diseases, and there is currently no effective diagnosis or treatment;
5. Medical devices that are urgently needed in clinical practice and are not approved for registration in China.
(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 For the case of compliance with items (1) and (2) of Article 2 of the Procedure, the applicant shall submit an application form for priority approval of medical devices at the time of filing the application for registration of medical devices.
For the application for priority approval of medical devices in the second item (1) of the procedure, the applicant shall also submit the relevant certification documents for the product to be included in the national science and technology major special project or the national key research and development plan.
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