How to apply for a class of medical device license

Class I medical devices do not have a production license, so there is no need to apply. The materials to be submitted when applying for a class I medical device license are as follows:

1, "Medical Device License Application Form" (1 original);

2, "Business License" (copy);

3, Organization Code Certificate (copy);

4, legal representative, responsible person for the enterprise, the person in charge of quality of the identity of the person in charge of the certificate of education or title certificate (a copy);

5, quality management personnel's work resume (1 original);

6, list of professional and technical personnel (1 original) and professional and technical personnel's identity card, proof of academic qualifications, title certificates (a copy of each);

7, organization and departmental setup description;

8, scope of business, Description of the mode of operation;

9, business premises, warehouse address location map, floor plan, documents proving ownership of the house or by the housing lease issued by the housing lease certificate copy. Warehousing commissioned by the third-party logistics of medical devices, provide a commissioning contract (a copy);

10, business facilities, equipment catalog.

Legal basis: "Supervision and Administration of Medical Devices Regulations" Article 21

Registered Class II, Class III medical device products, its design, raw materials, production processes, scope of application, use of methods and other substantial changes that are likely to affect the safety of the medical device, effective, the registrant shall apply for registration procedures for change; occurring in the original registration department. Apply for a change in registration procedures; other changes, should be in accordance with the provisions of the State Council drug supervision and management department for the record or report.