A class of medical equipment business filing process

A class of medical devices filing process is as follows:

1, open the browser, enter the business location of the government service center, submit a pre-approval application to generate a pre-acceptance number.

2, the applicant needs to submit paper application materials to the window.

3, the relevant departments will be reviewed after acceptance, acceptance of conditions, do not meet the return, incomplete materials, a one-time tell the applicant to correct the material.

4, will be handed over to the higher authorities for approval, to be filed for the production of certificates, issued by the production of Class I medical devices for the record vouchers, inadmissible to issue a notice of non-adoption.

5, the applicant in the window to get the first class medical device production record certificate or not through the decision.

Class I medical device products for the record, by the filing of the municipal people's government in charge of drug supervision and management of the municipal people's government to submit the record information.

A class of medical devices for the record process materials are as follows:

1, "Class I Medical Device Filing Form";

2, Safety Risk Analysis Report;

3, Product Technical Requirements;

4, Product Inspection Report;

5, Clinical Evaluation Information;

6, Product Specifications and Minimum Sales Unit Labeling Design Sample;

7, Manufacturing Information;

8, Supporting Documentation;

9, The first class of medical devices for the record process materials are as follows.

8, supporting documents;

9, Declaration of Conformity;

10, proof of authorization of the operator and the operator's identity card original and copy.