Chapter VI Product Registration
Article 38 To apply for medical device registration, the applicant shall submit the application materials to the corresponding food and drug supervision and administration department as required.
The registration application materials shall be in Chinese. If the application materials need to be translated in a foreign language, the original text shall be provided at the same time. When citing unpublished documents, the supporting documents recognized by the data owner shall be provided. The registration application materials shall be complete and standardized, and the data shall be true and reliable.
The applicant shall take full responsibility for the authenticity of the registration application materials.
Article 39 After receiving the application, the food and drug supervision and administration department shall conduct a formal examination and deal with it according to the following circumstances:
(a) the application matters belong to the scope of functions and powers of the department, and if the application materials are complete and meet the requirements of formal examination, it shall be accepted;
(2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;
(3) If the application materials are incomplete or do not meet the requirements of formal examination, the applicant shall be informed of all the contents that need to be corrected at one time within five working days. If the application materials are not informed within the time limit, it shall be accepted as of the date of receipt of the application materials;
(four) if the application matters do not fall within the scope of authority of the department, it shall immediately inform the applicant that it will not be accepted.
When accepting or rejecting an application for registration of medical devices, the food and drug supervision and administration department shall issue a notice of acceptance or rejection stamped with the special seal of the department and dated.
Article 40 The food and drug supervision and administration department that accepts the application for registration shall, within 3 working days from the date of acceptance, forward the application materials to the technical evaluation institution.
The technical review institution shall complete the technical review of the registration of Class II medical devices within 60 working days, and complete the technical review of the registration of Class III medical devices within 90 working days.
Article 41 The technical review institution of the food and drug supervision and administration department shall conduct technical review on the application materials for registration, and may consult the original research materials when necessary. In the process of review, if it is necessary to consult experts or hold a hearing, or if it is necessary to jointly review pharmaceutical machinery combination products with drug review institutions, the technical review institutions shall inform the applicant in writing, and the time required for consulting experts or holding a hearing shall not be counted within the prescribed review period. The review time limit of medical device combination products shall be implemented in accordance with relevant regulations.
Forty-second in the process of technical evaluation, the technical evaluation institution shall inform the applicant of all the contents that need to be corrected at one time. The applicant shall, within 1 year from the date of receiving the notice of correction, provide the correction information according to the requirements of the technical evaluation institution; The technical review institution shall complete the technical review within 60 working days from the date of receiving the corrected information. The time for the applicant to correct the information is not counted in the audit time limit.
Article 43 If the applicant fails to submit the supplementary materials within the time limit, the technical review institution shall put forward a proposal to terminate the technical review to the food and drug supervision and administration department that accepts the registration, and the food and drug supervision and administration department shall make a decision to return the application after approval and terminate the review.
Extended data
According to the Measures for the Administration of Registration and Filing of Medical Devices
Chapter III Product Technical Requirements and Registration Inspection
Fifteenth the applicant or the filing person shall prepare the technical requirements for the medical device products to be registered or filed. Product technical requirements refer to the product performance indicators and inspection methods of finished medical devices.
The product technical requirements of Class II and Class III medical devices shall be recognized by the food and drug supervision and administration department when approving the registration. The medical devices listed by the applicant or the applicant in China shall meet the technical requirements of products that have been registered, approved or filed.
Article 16 Registration inspection of medical devices refers to the inspection of products by medical device inspection institutions according to the applicant's application and the technical requirements of products.
Article 17 Anyone who applies for the registration of Class II and Class III medical devices shall accept the registration inspection. Only products that have passed the registration inspection can be used in clinical trials or applied for registration.
Article 18 A medical device inspection institution shall have the qualification of medical device inspection, conduct inspection within its inspection scope, and pre-evaluate the technical requirements of the products submitted by the applicant. The pre-evaluation opinions shall be issued to the applicant together with the registered inspection report.
Nineteenth medical devices that are not included in the scope of medical device inspection institutions shall be inspected by qualified inspection institutions designated by the corresponding registration and examination and approval departments.
Article 20 The products inspected by the same registered entity shall be typical products that can represent the safety and effectiveness of other products of the registered entity.
Twenty-first registration inspection, the applicant shall submit a written application to the inspection agency, and provide relevant technical information, registered inspection samples and product technical requirements.