Supporting Documents
(1) The domestic applicant shall submit:
1. A copy of the business license of the enterprise and a copy of the organization code certificate.
2. In accordance with the "Special Approval Procedures for Innovative Medical Devices Approval" of the domestic medical device application for registration, should be submitted to the Special Approval of Innovative Medical Devices application for review of the notification form, samples entrusted to other enterprises to produce, should be provided with the production license of the entrusted enterprise and commissioning agreement. Production license production scope should cover the declared product categories.
(B) overseas applicants should submit:
1. overseas applicants registered or production address in the country (region) where the competent authority for medical devices to allow the product marketed and sold on the documents issued by the competent authority, the enterprise qualification documents.
2. Foreign applicants registered or production address in the country (region) is not the product as a medical device management, the applicant needs to provide relevant documents, including registration or production address in the country (region) to allow the product on the market and sale of documents.
3. The power of attorney of the foreign applicant to designate an agent in China, the agent's commitment and a copy of the business license or a copy of the agency registration certificate.
The above information should have the parties to find the relevant departments to issue documents