(1) corporate materials
① medical device manufacturing license or business license (only the national general agent of imported products) copy, business license (copy) original and copy;
② "legal person power of attorney" and the authorized person's information card;
3 last year a single enterprise VAT Tax statement (copy), balance sheet, profit and loss statement;
④Basic information sheet of the enterprise;
⑤General List of Enrolled Varieties, Letter of Commitment to Supply;
⑥Other relevant documents and materials.
(2) product materials
① "Medical Device Registration Certificate" and the attached table, manufacturing approval form or a copy of the registration form and attached pages;
② through the U.S. FDA certification or EU CE certification of the bidding product, must provide a copy of the relevant certification issued by the certification body and a valid Chinese translation, Customs declarations, etc.;
③ product Instruction manual (without instructions, according to the instructions on the packaging can be printed on A4 paper and stamped; foreign language instructions on the performance and composition of the technical parameters should be translated into Chinese);
④Provide products in kind and image data;
⑤ Other relevant documents and materials.
2. Format Requirements for Declaration Materials
(1) The declaration materials are uniformly made on A4 paper.
(2) Declaration materials such as photocopies should be clear and page by page with the official seal of the unit.
(3) All documents and correspondence submitted are in Chinese. Foreign language original information to provide the corresponding Chinese translation and notarized by a notary public.
(4) The declaration materials must be bound according to the requirements, the agency has the right to refuse to accept the materials that do not meet the requirements.