Supply cycle of imported medical equipment and accessories

Sales, maintenance and service of accessories for Class II and Class III medical devices need to apply for a Medical Device Business License.

1. Medical Device Business License is a necessary document for medical device business enterprises. The establishment of a class I medical device trading enterprise shall be filed with the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government;

2. The establishment of Class II and Class III medical device trading enterprises shall be examined and approved by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, and a License for Medical Device Trading Enterprises shall be issued;

3. Without the Medical Device Business License, the administrative department for industry and commerce shall not issue a business license. The validity period of the Medical Device Business Enterprise License is 5 years;

4. Accessories of medical devices are generally non-medical devices. If the accessories also belong to medical devices, you need to apply for a medical device business license. If the wheelchair is a medical device, but the wheel of the wheelchair is not a medical device, it is obviously unnecessary to sell, replace and repair the wheel with a medical device business license;

5. However, if it is a combined medical device, if the medical device is composed of several different medical devices, and an attachment belongs to another medical device at the same time, it is necessary to apply for a medical device business license.