Do I need a medical device registration certificate for the import of medical device parts and accessories? Are labeling and instructions required?

According to China's Regulations for the Supervision and Administration of Medical Devices, a medical device registration certificate is required for the importation of medical devices and their accessories. The medical device registration certificate is a kind of evaluation and approval for the safety and effectiveness of medical device products. By obtaining the registration certificate, you can legally import and sell medical devices and their accessories.

At the same time, imported medical devices and their accessories also need labeling and instructions. Labels need to indicate the name of the product, model specifications, manufacturer information, use, precautions and other necessary information. Instruction manuals need to describe in detail the performance of the product, indications, contraindications, side effects, precautions and other necessary information to meet the user's needs for the correct use and safe use of the product.

It should be noted that the specific requirements may vary for different medical devices and accessories. If you want to import specific medical devices and their accessories, it is recommended that you consult with the relevant departments or organizations before importation to ensure compliance with the relevant regulations and requirements.