Requirements for applying for a Class III Medical Device License:
General Class III Medical Device License:
1, there are eligible business premises (office area ≥ 100 ㎡, storage area > 60 ㎡);
2, there are eligible business product certificates;
3, 3 related personnel to record the information and hold the certificate.
Disposable sterile Class III Medical Device License:
1, with the required business premises (office area of ≥ 60 square meters, warehousing area of > 80 square meters);
2, with the required business product certificates;
3, 3 related personnel to record information and hold a certificate.
In vitro diagnostic reagents Class III Medical Device License:
1, with the required business premises (office area ≥ 60 square meters, warehousing area of > 100 square meters, cold storage volume of > 40m?);
2, there are required to operate the product certificates;
3, 3 related personnel to record information and hold a certificate.
Application for Class III medical device license required information:
1, form;
2, a copy of the business license;
3, the legal representative or person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of the certificate, education or title;
4, the enterprise's business premises, warehouse address of the geographic location of the map, the floor plan; (indicating the actual) (using the site)
5, housing lease contract;
6, business facilities and equipment product certificate information;
7, business quality management system, work procedures and other documents catalog;
8, other supporting materials.
Application for Class III medical device license process:
1, acceptance:
The applicant to the administrative acceptance of the service center to apply, in accordance with the catalog listed in Article VI of the "Notes" submit application materials, acceptance of the center in accordance with the "territory of the third type of medical equipment, overseas medical device registration declaration information acceptance criteria" (State Drug Administration [2005] 111) of the staff Requirements for application materials for formal review. Application matters are not required by law to obtain administrative licenses, the applicant should be informed immediately inadmissible; application matters do not belong to the administrative organ's terms of reference, it should be made immediately inadmissible decisions, and inform the applicant to the relevant administrative organs; application materials can be corrected on the spot errors, the applicant should be allowed to correct on the spot; the application materials are incomplete or do not meet the statutory form, it should be On the spot or within five days to inform the applicant of all the contents of the need to make corrections, late notification, from the date of receipt of the application materials shall be accepted; application matters within the purview of the administrative organ, the application materials are complete, in line with the statutory form, or the applicant in accordance with the requirements of the administrative organ to submit all the corrections to the application materials, the application for administrative licenses shall be accepted.
2, review:
Administrative acceptance of the service center after acceptance, the application materials will be sent to the Medical Device Technical Review Center for technical review, technical review, including product testing and expert review, the technical review can not exceed 60 days. However, after the expert review, the applicant puts forward corrective comments, the applicant rectification time is not counted in the licensing time limit.
3, licensing decisions:
Received from the Center for Technical Review of Medical Devices to complete the technical review of the information, the State Food and Drug Administration within 30 days to make the decision to be registered or unregistered, unregistered, it should be a written statement of reasons.
4, delivery:
Since the administrative licensing decision within 10 days from the date of the decision, CFDA administrative acceptance of the service center will be sent to the applicant administrative licensing decision.