1, medical device business license
2, medical device registration certificate (including medical device registration application form)
3. Automatic Import License for Mechanical and Electrical Products/Mechanical and Electrical Certificate /O Certificate
4,3c certification
5. Photographs, nameplates, technical parameters, end use and Chinese description of the equipment;
6 box invoice, contract bill of lading, organization code certificate and business license
7. Other materials that need to be declared.
Note: Whether mechanical and electrical certificate and 3C are needed should be treated according to the specific goods.
If you need an electromechanical certificate or 3C, you need to prepare the electromechanical certificate or 3C in advance to avoid delaying the customs declaration and inspection.
2. What information should be declared for the registration of imported medical devices?
1, overseas medical device registration application form
2, medical device manufacturing enterprise qualification certificate
3. A copy of the applicant's business license and the power of attorney for agency registration issued by the production enterprise.
4, overseas government departments in charge of medical devices approved or recognized the product as a medical device to enter the country (region) market documents.
5. Applicable product standards
6. Instructions for medical devices
7. The product belongs to the first class, and the product registration test report issued by the medical device testing institution is not required. )
8. Clinical trial data of medical devices (three types of implanted products entered China for the first time and other products of this manufacturer were not registered by sfda; And class II and III products that have not been approved for marketing abroad need to be clinically tested in China).
9. Product quality guarantee issued by the manufacturer.
10. Power of attorney, agent commitment letter, business license or organization registration certificate of the production enterprise in China.