According to the "Measures for the Administration of Medical Device Registration"
Article 9 The first class of medical device products for the record and apply for the registration of the second and third class of medical device products, the following information should be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product test report;
(d) clinical evaluation information;
(e) product specifications and labeling samples;
(f) quality management system documents related to the development and production of the product;
(g) other information necessary to prove the product's safety and effectiveness.
Article XI application for registration of Class II medical device products, the applicant for registration shall submit to the local food and drug administration department of the people's government of the province, autonomous region and municipality directly under the Central Government to apply for registration. Apply for registration of Class III medical device products, the applicant shall submit the registration application to the State Council Food and Drug Administration.
The second and third class of medical device product registration application information in the product inspection report shall be a medical device inspection agency issued the inspection report; clinical evaluation information shall include clinical trial report, but in accordance with the provisions of Article 17 of the Regulations are exempted from clinical trials of medical devices.