1. Prepare the application form: the application form must be bilingual in Chinese and English, and all items must be complete, and the blank column can be indicated by a slash "/". The name, specification, model, manufacturer's name and address of the device in the application form must be completely consistent with the contents specified in the approval document of the country of origin (region), and must be consistent with the contents in the test report, product instruction manual and other related documents.
2. Prepare the applicant's qualification documents: the applicant needs to provide his own qualification documents to prove that he is qualified to legally operate medical devices.
3. Prepare the implementation documents of registered product standards: documents that meet the management measures of medical device standards and prove that registered products meet the requirements of relevant standards.
4. Provide product instruction manual: it is necessary to provide the instruction manual of the product, and describe in detail the usage method and precautions of the product.
5. Provide type test report: Type test report issued by the medical device quality inspection institution recognized by the Drug Administration in the past year shall be provided for the second and third categories of products.
6. Provide clinical trial report: For products requiring clinical trial, it is necessary to provide clinical trial report of medical devices. Clinical trial reports shall be provided in accordance with the Sub-Provisions on Clinical Reports of Medical Device Registration, and clinical trials shall be conducted in accordance with the requirements of the Administrative Measures for Clinical Trials of Medical Device Products.