The qualifications that an importing enterprise must possess:
1. Import and export operation rights;
2. Business license (there is a license to sell medical devices within the business scope);
3. Medical device registration certificate;
4, medical device business license.
Documents to be provided for medical devices/equipment:
1. Registration certificate and business license of imported medical equipment issued by the State Food and Drug Administration;
2, belongs to the meaning of pharmaceutical ingredients of medical equipment, shall provide the China compulsory certification (special goods approval form);
3. Automatic import license (O certificate) is required for some equipment;
4. Photographs, nameplates, technical parameters, end use and Chinese instructions of the equipment;
5. Import contract, packing list and invoice；;
6. Other materials that need to be supplemented.
What should I pay attention to when declaring imported medical devices?
According to the Regulation on the Supervision and Administration of Medical Devices, except in special circumstances such as donation, imported medical devices must be filed or registered by the State Food and Drug Administration. At present, the customs and food and drug supervision departments have realized the data networking verification, and the automatic comparison can be realized by filling in the number of the filing or registration certificate when reporting, without uploading the paper certificate. At the same time, because imported medical devices are used in China, they must be equipped with Chinese instructions and product labels.
The safety identification and electromechanical safety items of imported medical devices must meet the requirements of China's mandatory standards. As described in the above case, and other situations that do not meet the requirements of our country are not allowed.
Most second-hand medical devices belong to products that are forbidden to be imported by our laws and policies. If they are imported, they have to be returned or destroyed directly, but this is not worth the loss. In addition, if there are other questions about imported medical devices, you can directly contact the customs or the food and drug supervision department to avoid the safety risks of imported goods.