Enterprises to the local provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department to apply, fill out the "Medical Device Manufacturer License (start-up) Application Form", and submit the following materials:
1, the legal representative, the person in charge of the enterprise's basic information and proof of qualifications;
2, industrial and commercial administration department issued by the proposed pre-approval of the enterprise name Notification;
3, enterprise production, quality and technical personnel in charge of the resume, education or title certificate; relevant professional and technical personnel, skilled workers registration form, and indicate the department and position; senior, intermediate, junior technical personnel ratio table;
4, the proposed scope of production products, varieties and related product profile; production site documents
5, The main production equipment and inspection equipment catalog;
6, the proposed production of products and process flow diagrams, and indicate the main control items and control points;
7, the production of sterile medical devices, should provide the production environment test report.
Process:
1, the application does not belong to the department's terms of reference, shall immediately make a decision of inadmissibility, and inform the applicant to the relevant administrative organs;
2, the application materials can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
3, the application materials are incomplete or do not meet the formal examination Requirements, shall be issued on the spot or within five working days to the applicant "Notice of Corrective Material", a one-time notification to the applicant needs to make corrections to all the contents of the late notification, since the date of receipt of the application materials shall be accepted;
4, the application materials are complete, meet the requirements of the formal review, or the applicant in accordance with the requirements of the submission of all the corrective application materials, shall be admissible.
5, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments to accept or not accept the application for the start-up of medical device manufacturers, should be issued with the department's acceptance of the special seal and date of the "acceptance of the notice" or "notice of inadmissibility.
6, the review meets the requirements, to make a written decision to grant a license, and within 10 working days to send "medical device manufacturer license. After review does not meet the requirements, to make a written decision not to issue a license, and explain the reasons.
Expanded Information
Note:
1, has been registered Class II, Class III medical devices, medical device registration certificate and its annexes to the content of the change, the applicant should be registered to the original registration department to apply for registration changes, and in accordance with the relevant requirements for the submission of declarations.
2, has been filed for the medical device, the management category adjustment for the second or third class of medical devices, the filer should take the initiative to the appropriate food and drug supervision and management department to cancel the original filing.
3, not in accordance with the law to deal with the second class, the third class of medical devices registered matters change the sale, use, by the food and drug supervision and management department at or above the county level ordered to make corrections within a period of time.
Baidu Encyclopedia - Class II Medical Devices