CCIC North America Consulting

Medical devices refer to the instruments, equipment, appliances, materials or other articles used alone or in combination for human body, including the required software; their functions on human body surface and inside the body are not obtained by the means of pharmacology, immunology or metabolism, but may participate and play a certain auxiliary role.

People’s Republic of China has a complete set of management system for medical devices sold or used in China.  According to the medical devices use security, they are divided into I, II and III categories.

According to 《Medical Device Supervision and Administration Regulations》, relevant regulations have been made on the development, production, operation, use and supervision of medical devices in China.  In particular, the filing and registration of imported medical devices are explained as follows:

On the China’s side of international trade, importers may also need some related licenses and permits from the local government.  CCIC Chicago will provide coordination and communication services in this regard.

In addition, many other important processes are involved in medical devices exporting business to China, including customs clearance, price verification, tariff, commodity inspection and post-market supervision, etc. Some imported medical devices for specific uses could also apply for possible tax exemption.

In summary, a new medical device product has a list of steps for entering China market:

1. Accurately classifying the device according to Chinese standards;
2. Preparing registration or filing materials according to classification results and submit them to China National Medical Products Administration;
3. Preparing materials and documents for customs clearance.

CCIC Chicago provides a complete set of professional consulting, communication, document and coordination services for the export of medical devices to China.