How to apply for a medical device license, how long is the validity period

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 examination 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

Tools / Raw Materials

(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) industrial and commercial administration department issued the "pre-approval of the enterprise name notification";

(c) Personnel information;

1, to be the 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, to be the quality management personnel of the enterprise's identity card, copies of certificates of academic or professional and technical positions and personal resume, employment agreements, health certificates;

3, to be the Enterprise personnel roster, and health certificates. The content of the roster includes: name, gender, age, professional and technical positions/education, position/post.

(4) the proposed enterprise organization and functions;

enterprises to develop the organizational structure of the block diagram, clearly and unambiguously identify 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/Methods

1 to the Provincial Drug Administration or Municipal Drug Administration to submit the application information for formal review

2 form of review there are two results. 1, the project is accepted 2, not accepted

3 through the form of review, it will be carried out administrative review and technical review (including expert review, on-site acceptance)

4 administrative review and technical audit Both through the administrative audit and technical audit, will be made and closed

5 Finally, waiting for notification to the acceptance of the Office to receive the document

1, the medical device manufacturing license is valid for five years.

2, "Medical Device Supervision and Administration Regulations" Article 21 provides that: engaged in the production of Class I medical devices, by the manufacturer to the municipal people's government of the location of the food and drug supervision and management department for the record.

3, "supervision and management of medical devices regulations" Article 22 provides: engaged in the production of Class II, Class III medical devices, the manufacturer shall apply to the local food and drug supervision and management department of the people's government of the province, autonomous region and municipality directly under the Central Government for a production license. Medical device production license is valid for 5 years. The expiration of the validity of the need for continuation, in accordance with the relevant administrative licensing laws and regulations for the continuation of procedures.

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