Ordinary Class III medical device license:

1. It has qualified business premises (office area ≥ 100㎡, storage area > 60 ㎡);

2. Have a qualified product certificate;

3. Relevant personnel shall file information and hold certificates.

Disposable sterile Class III medical device license:

1. It has qualified business premises (office area ≥ 60m2, storage area > 80m2);

2. Have a qualified product certificate;

3. Relevant personnel shall file information and hold certificates.

In vitro diagnostic reagent Class III medical device license:

1, with qualified business premises (office area ≥ 60m2, storage area >100m2, cold storage volume > > 40m? );

2. Have a qualified product certificate;

3. Relevant personnel shall file information and hold certificates.

Materials required for applying for Class III medical device license:

1, form;

2. A copy of the business license of the enterprise;

3, the legal representative or person in charge of the enterprise, the person in charge of quality education or professional title certificate;

4. The geographical location map and plan of the enterprise's business premises and warehouse address; (indicate the actual place of use)

5. Housing lease contract;

6, operating facilities and equipment product certificate information;

7, enterprise management quality management system, working procedures and other documents directory;

8. Other supporting materials.

Procedures for applying for three types of medical device licenses:

1, accepted:

The applicant shall apply to the administrative acceptance service center and submit the application materials according to the catalogue listed in Article 6 of this Notice. The staff of the acceptance center shall formally review the application materials according to the requirements of the Acceptance Standard for Registration Application Materials of Class III and Overseas Medical Devices in China (Guo Ban Fa [2005] 165438). If the application does not need to obtain an administrative license according to law, it shall immediately inform the applicant that it will not be accepted; If the application matters do not fall within the scope of functions and powers of the administrative organ according to law, it shall immediately make a decision not to accept it, and inform the applicant to apply to the relevant administrative organ; 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; If the application materials are incomplete or do not conform to the statutory form, the applicant shall be informed of all the contents that need to be corrected on the spot or within five 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; If the application matters fall within the scope of functions and powers of this administrative organ, the application materials are complete and conform to the statutory form, or the applicant submits all the application materials for correction according to the requirements of this administrative organ, it shall accept the application for administrative license.

2. Review:

After accepting the application, the administrative acceptance service center will send the application materials to the medical device technical review center for technical review, which includes product testing and expert review, and the longest technical review can not exceed 60 days. However, if the applicant puts forward rectification opinions after expert review, the applicant's rectification time shall not be included in the licensing time limit.

3. Licensing decision:

China Food and Drug Administration shall make a decision on whether to register within 30 days after receiving the technical review materials completed by the Medical Device Technical Review Center. Otherwise, the reasons shall be explained in writing.

4. Delivery:

Within 10 days after the decision of administrative license is made, CFDA administrative acceptance service center will deliver the decision of administrative license to the applicant.