First, the content requirements (1) Application Form for Special Approval for Innovative Medical Devices Applicants should fill in all the content truthfully. The product performance structure and composition, the main working principle / mechanism of action, and the content of the intended use should be able to reflect all the important information of the product characteristics, concise, concise, professional, and not easy to produce ambiguity. (2) Special approval for innovative medical device applications (if applicable) For the re-applied innovative medical devices, a copy of the “Innovative Medical Device Special Approval Application Review Notice†must be provided, and the product changes and the details of the application materials should be submitted. (3) Applicant enterprise legal person qualification certificate 1. Domestic applicants should submit: A copy of the business license and a copy of the organization code certificate. 2. Overseas applicants should submit: The corporate legal person qualification certificate issued by the competent department of the country (region) where the foreign applicant is registered. Documents must be signed by the original issuing authority or notarized by a local notary. (4) Product intellectual property rights and supporting documents 1. Provide information on the intellectual property rights of the core technologies of the applied medical devices. If there are a number of invention patents, it is recommended to display the name of the invention patent, the patentee, and the status of the patent in a list. 2. Provide relevant intellectual property rights certification documents (1) If the applicant has obtained the invention patent right, it shall provide the original copy of the patent authorization, the claim, the copy of the specification and the patent registration form signed by the applicant. (2) If the applicant obtains the right to use the invention patent in China by law, he shall provide the copy of the patent authorization, the claim, the specification, and the copy of the patent registration book held by the patentee. The original of the "Certificate of Patent Implementation License Contract" issued by the department. (3) If the invention patent application has been disclosed by the patent administration department under the State Council and has not been authorized, the publicly available documents of the invention patent signed by the applicant (such as the notice of publication of the invention patent application, the publication of the invention patent application and the substantive examination) Copy of the notice of the stage, the notice of the invention patent entry into the substantive examination stage, etc.) and the copy of the published version of the claim and the manual. In the process of reviewing the application for invention patents, if the claims and instructions are subject to revision by the patent examination department, the revised text shall be submitted; if the patentee changes, the certification documents issued by the competent patent authority shall be submitted, such as a copy of the formalities for the passing of the formalities. . (V) Summary of product development process and results Review the original intention of product development and laboratory research, animal experiment research, clinical research and results, and submit a comprehensive report on product development including design input, design verification and design output. Face Masks,Medical Facemask,Filtration Isolation Medical Facemasks,Anto-Bacteria Face Masks Zhende Medical Co.,Ltd , https://www.zdmedicalproducts.com