A class of medical device registration application materials:

(1) Application form for registration of domestic medical devices;

(2) Qualification certificate of medical device manufacturing enterprise: a copy of business license;

(3) Applicable product standards and descriptions: If national standards and industry standards are adopted as applicable standards for products, the texts of the adopted national standards and industry standards shall be submitted; The registered product standard shall be signed and sealed by the production enterprise. The production enterprise shall provide a statement that the product applied for conforms to the national standards and industry standards, a statement that the production enterprise assumes the quality responsibility after the product is listed, and a description of the product model and specification division. "Signature" here refers to the seal of the enterprise, or the signature of its legal representative and responsible person plus the seal of the enterprise (hereinafter referred to as domestic medical devices, synonymous);

(four) product performance test report;

(5) A description of the existing resource conditions and quality management capabilities (including testing methods) of the products produced by the enterprise;

(6) Instructions for medical devices;

(7) Self-assurance statement on the authenticity of the submitted materials: it shall include the list of submitted materials and the commitment of the production enterprise to bear legal responsibilities. ?

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

(1) Qualification certificate of medical device manufacturing enterprise.

(2) product technical report.

③ Safety risk analysis report.

(four) the registered product standards and compilation instructions.

(five) product performance self-inspection report.

(6) Type test report of product trial production registration issued by the medical device quality testing institution recognized by the State Medical Device Administration in the past year (biological materials in the first half year of clinical trial).

(seven) clinical trial reports of more than two clinical trial bases. Reports shall be provided in accordance with the Sub-Provisions on Clinical Trial Reports of Medical Device Registration (see Annex), and clinical trials shall be implemented in accordance with the Administrative Measures for Clinical Trials of Medical Device Products.

(8) Product description.

(9) A self-assurance statement on the authenticity of the submitted materials.

References:

Baidu Encyclopedia-Medical Device Registration Certificate