What materials should be submitted for the registration of Class III medical device license?

There are also requirements for application materials when the three types of medical devices are licensed for registration. The first page of the application materials is the catalogue of application materials, and the application materials in the catalogue are arranged in the order of Annex 3 of the Measures for the Administration of Medical Device Registration. Each document has a cover, which indicates the product name and the applicant's name, and the name of the document is indicated in the upper right corner. There should be obvious difference marks between materials, and the name of the material or the number in the catalogue where the material is located should be indicated. The whole set of information should be bound into a book. The application materials are in duplicate. The application materials shall be printed on A4 paper, with complete and clear contents, and shall not be altered. Documents issued by the government and other institutions shall be provided in the original size. A copy of the application materials should be clear. The product name in the application materials (listing approval documents, standards, test reports and instructions) should correspond to the substantive content of the product name filled in the application form. After the application materials are accepted, the enterprise may not supplement the application by itself, but it may supplement the application if it falls under the circumstances stipulated in Article 38 of the Measures for the Administration of Medical Device Registration.