How to apply for medical device license

Medical equipment business license is a medical device business enterprises must have the documents, the opening of the first class of medical equipment business enterprises, should be to the provinces, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department for the record; the opening of the second class, the third class of medical equipment business enterprises, should be by the provinces, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department for review and approval, and issued the "medical equipment business enterprise". License". No "medical device business enterprise license", the administrative department for industry and commerce shall not issue a business license. Medical Device Business License" is valid for five years

(a) apply for the establishment of a medical device business report, fill out or print the "Medical Device Business License Application Form" (four copies);

(b) "pre-approval of the enterprise name notification" issued by the administrative department for industry and commerce;

1, the proposed legal representative and the person in charge of the enterprise's identity card, household register or relevant certificates issued by the public security organs and other documents and educational certificates, health certificates;

2, the proposed quality management personnel of the enterprise's identity card, copies of certificates of educational or professional and technical positions and individual practitioner resume, employment agreements, health certificates;

3, the proposed enterprise roster of personnel, as well as health certificate. The content of the roster includes: name, gender, age, professional and technical position/education, position/post.

(d) the proposed enterprise organization and functions;

enterprises to develop the organization of the block diagram, clearly and unambiguously identifies the internal division of labor, as well as the functions of the enterprise personnel positions.

(E) the proposed enterprise registered address, warehouse address of the geographical location map, floor plan (indicating the area), proof of ownership of housing (or lease agreement) copy.

(F) the proposed enterprise product quality management system documents and storage facilities, equipment catalog;

(G) the proposed enterprise business varieties catalog;

Catalog includes the following: product name, manufacturer, specifications, registration certificate number, as well as the corresponding product storage conditions, requirements of the description.

Steps:

Submit application materials to the provincial or municipal Drug Administration for formal review

There are two results of the formal review: 1) acceptance of the project and 2) inadmissibility

Passing the form of review, the administrative review and technical review (including expert review and on-site acceptance)

Administrative and technical reviews are passed, the license will be finalized. The final wait for the notification to the acceptance of documents

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