1, basic information and qualification certificates of the legal representative and the person in charge of the enterprise;
2. Notice of pre-approval of the name of the proposed enterprise issued by the administrative department for industry and commerce;
3, enterprise production, quality and technical director's resume, education or professional title certificate; Registration forms of relevant professional and technical personnel and skilled workers, and indicate their departments and posts; Table on the proportion of senior, intermediate and junior technicians;
4, the scope of products to be produced, varieties and related products; Certificate of production site
5, the main production equipment and inspection equipment directory;
6, the process flow chart of the products to be produced, and indicate the main control items and control points;
7, the production of sterile medical devices, it shall provide the production environment test report.
Process:
1. If the application matters do not fall within the scope of functions and powers of the department according to law, it shall immediately make a decision not to accept it, and inform the applicant to apply to the relevant administrative organ;
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, the application materials are incomplete or do not meet the requirements of formal examination, it shall be on the spot or within 5 working days issued to the applicant "Notice of Supplementary Materials", a one-time inform the applicant of all the contents that need to be supplemented, fails to inform, since the date of receipt of the application materials is accepted;
4. If the application materials are complete and meet the requirements of formal examination, or the applicant submits all the corrected application materials as required, it will be accepted.
5, provinces, autonomous regions, municipalities directly under the central government (food) drug supervision and management departments to accept or reject the application for the establishment of medical device manufacturing enterprises, it should be issued with the special seal of the department to accept and indicate the date of the "acceptance notice" or "rejection notice".
6. If it meets the requirements after examination, a written decision shall be made to grant the license, and the Medical Device Manufacturing Enterprise License shall be issued within 10 working days. If it does not meet the requirements after examination, it shall make a written decision not to issue the certificate and explain the reasons.
Extended data
Precautions:
1, the registered Class II and Class III medical devices, and the contents specified in the medical device registration certificate and its annexes change, the applicant shall apply to the original registration department for registration change, and submit the application materials according to the relevant requirements.
2. If the management category of medical devices that have been filed is adjusted to Class II or Class III medical devices, the filing person shall take the initiative to propose to the corresponding food and drug supervision and administration department to cancel the original filing.
3. If the registered items of Class II and Class III medical devices are not changed for sale and use according to law, the food and drug supervision and administration department at or above the county level shall order it to make corrections within a time limit.
Baidu encyclopedia-second class medical equipment