The sale, repair and service of accessories of Class II and Class III medical devices need to apply for the "Medical Device Business License".
1, medical equipment business license is a medical device business enterprises must have the documents, the opening of the first class of medical equipment business enterprises, should be to the provincial, autonomous regions, municipalities directly under the Central People's Government Drug Administration for the record;
2, the opening of the second class, the third class of medical equipment business enterprises, should be by the provincial, autonomous regions, municipalities directly under the Central People's Government Drug Administration for examination and approval, and issued the "Medical Device Business License". Approval, and issued a "medical device business license";
3, no "medical device business license", the administrative department for industry and commerce shall not be issued a business license. Medical Device Business License" is valid for 5 years;
4, medical equipment accessories are generally non-medical devices, if the accessories also belong to the medical device needs to apply for a medical device license. If the wheelchair is a medical device, but the wheelchair wheels are not medical devices, sales, replacement, maintenance of wheels obviously do not need a "medical device license";
5, but if it is a combination of medical devices, such as the medical device has more than one combination of different medical devices, a certain accessory also belongs to another kind of medical device, you need to apply for a "medical device license".