The enterprise applies to the (food) drug regulatory department of the local province, autonomous region, or municipality directly under the Central Government, fills out the "Medical Device Manufacturing Enterprise License (Startup) Application Form", and submits the following materials:
1. Basic information and qualification certificates of the legal representative and person in charge of the enterprise;
2. Pre-approval notice of the proposed enterprise name issued by the industrial and commercial administration department;
3 , the resume, academic qualifications or professional title certificates of the person in charge of production, quality and technology of the enterprise; the registration form of relevant professional and technical personnel and technical workers, indicating the department and position; the proportion table of senior, intermediate and junior technical personnel;
4. Introduction to the scope, variety and related products of the products to be produced; production site certification documents
5. Catalog of main production equipment and inspection equipment;
6. Information about the products to be produced Process flow chart, and indicate the main control items and control points;
7. Those who produce sterile medical devices should provide a production environment test report.
Process:
1. If the application matters do not fall within the scope of the department’s powers according to law, a decision should be made immediately not to accept the application and the applicant should be informed to apply to the relevant administrative agency;
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2. If the application materials contain errors 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 formal review requirements, the applicant shall be allowed to correct them on the spot or in 5 A "Notice of Supplementary and Correction Materials" will be issued to the applicant within three working days, informing the applicant of all the necessary supplements and corrections at once. If the applicant is not notified within the time limit, the application will be accepted from the date of receipt of the application materials;
4. If the application materials are complete and meet the formal review requirements, or if the applicant submits all supplementary and corrected application materials as required, it will be accepted.
5. If the (food) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government accepts or refuses to accept an application for establishing a medical device manufacturer, it shall issue an "Acceptance" stamped with the department's special acceptance seal and dated. Notice" or "Notice of Rejection".
6. If the application meets the requirements after review, a written decision will be made to approve the issuance of the license, and a "Medical Device Production Enterprise License" will be issued within 10 working days. If the application does not meet the requirements after review, a written decision will be made not to issue the certificate and the reasons will be stated.