I, medical device registration application form
Medical device registration application form is one of the important information of the application for registration, the table should be in line with the instructions for filling out the requirements.
Second, the medical device manufacturer qualification certificate
(a) a copy of the manufacturer's license and copy of the business license, and stamped with the official seal of the enterprise to which the certificate belongs;
(b) the product should be applied for in the manufacturer's license within the scope of the approved production;
(c) in the validity of the period.
Three, product technical reports
should be stamped with the official seal of the manufacturer.
IV. 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 production enterprise;
(b) the preparation of instructions (applicable to the registered product standards);
(c) the declared 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 statement, and stamped with the official seal of the manufacturer; 2. Producers to assume responsibility for the quality of the product on the market, and stamped with the official seal of the producer;
3. Producers about the product model, specifications division of the description, and stamped with the official seal of the producer.
VI. Product performance self-test report
(a) 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.
Seven, test reports
(a) the specifications of the products tested should be within the scope of this application for registration;
(b) the type of test should be a 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 enterprise shall provide the corresponding explanatory documents, and stamped with the official seal of the production enterprise.
VIII, medical device clinical trial data
(a) the manufacturer should be more than two (including two) "national drug clinical research base" for clinical trials;
(b) its clinical trial data should include clinical trial contract, clinical trial program, clinical trial report
1. Clinical trial contract should be undertaken by the clinical trial of the medical institutions and implementers of the signature and seal;
2. Clinical trial program should be the Ethics Committee, 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 of the signatures of the person in charge of the clinical trial and the trial by the competent authorities to confirm the seal.
Nine, medical device instructions
Should provide instructions, instructions should be stamped with the official seal of the manufacturer; omitted instructions, should be issued by the manufacturer to explain the document, and stamped with the official seal of the manufacturer.
Ten, the product production quality system assessment (certification) of the validity of the documents
Eleven, the authenticity of the materials submitted by the self-assurance statement
(a) the list of materials submitted;
(b) the commitment of the manufacturer to assume legal responsibility;
(c) stamped with the official seal of the manufacturer.