Medical device registration application form is one of the important information of the registration application, the table should be in line with the instructions for filling out the requirements.
Second, the medical device manufacturer qualification certificates
(a) a copy of the manufacturer's license and a copy of the business license, and stamped with the certificate belongs to the company's official seal;
(b) the product should be applied for in the manufacturer's license approved within the scope of the production;
(c) in the validity of the period.
Third, the product technical report should be stamped with the official seal of the manufacturer.
Fourth, the safety risk analysis report
Should be stamped with the official seal of the manufacturer.
V. Product standards
(a) the standard text, should be stamped with the official seal of the manufacturer;
(b) the preparation of instructions (applicable to registered product standards);
(c) declared that the product should be included in the scope of the product standards;
(d) the use of national standards, industry standards as the applicable standards of the product:
1. Producers should provide the application of the product in line with national standards, industry standards, and stamped with the official seal of the producer;
2. Producers bear the responsibility for the quality of the product on the market after the statement, and stamped with the official seal of the producer;
3. Producers of the relevant product model, specifications division of the description, and stamped with the official seal of the producer.
VI. Product performance self-test report
(a) There should be the main inspector or the person in charge of the main inspection, the auditor's signature and stamped with the official seal of the manufacturer; (b) the implementation of national standards, industry standards, the manufacturer should be supplemented with self-defined factory test items, and stamped with the official seal of the manufacturer.
VII, test reports
(a) the specifications of the product inspected should be within the scope of this application for registration;
(b) the type of test should be registered test or full performance of the national supervision and sampling test;
(c) the original;
(d) in the validity period (implementation of the "Measures" Annex 3, Article 7).
Note: The implementation of the "Measures" Article 11, Article 12, Article 13 of the provisions of the production company should provide the corresponding description of the document, and stamped with the official seal of the production company.
VIII, medical device registration consulting clinical trial information
(a) The manufacturer should be more than two (including two) "national drug clinical research base" for clinical trials;
(b) its clinical trial information should include clinical trial contracts, clinical trial program, Clinical trial report:
1. Clinical trial contract should bear the clinical trial of the medical institutions and implementers of the signature and seal;
2. Clinical trial program should be the ethics committee, bear the clinical trial of the medical institutions and implementers of the seal;
3. Clinical trial report should be the person in charge of the clinical trial and the clinical trial personnel signed and stamped by the competent authority of the trial. Confirmation.
IX, medical device registration consulting manual
Instructions should be provided, instructions should be stamped with the official seal of the manufacturer; omitted instructions, should be issued by the manufacturer of documents and stamped with the official seal of the manufacturer.
X. Product production quality system assessment (certification) of the validity of the documents
XI, the authenticity of the materials submitted to the self-assurance statement
(a) the list of materials submitted;
(b) the manufacturer to assume legal responsibility for the commitment;
(c) the official seal of the manufacturer.