1, registration application form
2, the producer's legal production qualifications of the documents
3, the applicant's qualifications of the documents
a, the business license of the reporting unit, the scope of its business must be related to the medical device; the use of the period of time should be in its indicated validity period
b, the producer to give the proxy for the registration of the power of attorney
4, the country of origin (region) government approval or recognition of the role of the product medical device to enter the country's market documents.
5, the registered product technical standards
6, the State Food and Drug Administration recognized medical device quality testing organizations within the last year issued a type test report (for the second, three types of products)
7, clinical trial reports
8, product instructions
9, other information that may be helpful in the review
10, product quality guarantee issued by the producer of the product quality assurance that the products registered for sale in China and the country of origin (region) listed in the same product quality is completely consistent
11, designated in China after-sales service organization's power of attorney, letter of commitment, business license
12, the submitted material authenticity of the self-warranty statement