What is the registration process for a class of medical devices?

In accordance with the legal procedures, to apply for registration.

Application materials for registration of a class of medical devices:

(a) application form for registration of medical devices within the territory;

(b) proof of qualification of medical device manufacturers: a copy of the business license;

(c) the applicable product standards and instructions: the use of national standards, industry standards as the applicable standards of the product should be submitted to the adopted national standards, The text of industry standards; registered product standards should be signed by the manufacturer. Manufacturers should provide the application of the product in line with national standards, industry standards, the statement of the manufacturer to assume responsibility for the quality of the product on the market, as well as the product model, specifications of the division of the description. Here the "seal" means: enterprise seal, or its legal representative, the person in charge of the signature and enterprise seal (the following medical devices involved in the territory, the same meaning);

(d) the full performance of the product test report;

(e) the production of products of the enterprise's existing resources and quality management capabilities (including) the description of the means of testing;

(f) the production of products and quality management capacity (including) test means) of the description;

(F) medical device instructions;

(VII) submitted materials to the authenticity of the self-assurance statement: should include a list of materials submitted, the manufacturer's commitment to assume legal responsibility.

The following materials shall be submitted for the registration of trial production of Class II and Class III medical devices produced by domestic enterprises:

(I) Certificate of qualification of medical device manufacturer.

(ii) Product technical report.

(C) safety risk analysis report.

(D) Registered product standards and preparation instructions.

(E) product performance self-test report.

(F) State Drug Administration-recognized medical device quality testing organizations within the past year (biological materials for clinical trials within six months before) issued by the product trial production registration type test report.

(VII) more than two clinical trial base clinical trial report. The report provides the implementation of the "medical device registration clinical trial report sub-provisions" (see Annex), clinical trials to implement the "Medical Device Product Clinical Trial Management Measures".

(H) product instructions.

(ix) the submitted material authenticity of the self-assurance statement.

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