Medical equipment repair if there is involved in the sale of medical equipment accessories, this case is to apply for a business license. There is no sales involved in the general situation does not require formalities, you can call the local Drug Administration to consult.
Two, analyze the details
Medical equipment is a pre-approval, as long as the operation of medical devices need a medical device license, this can be to the local Food and Drug Administration consulting, but also on the website to apply for the application for a medical device license application. And submit materials as required. However, according to the requirements of the Food and Drug Administration to operate medical devices have to have a relevant professional quality management, and must comply with the provisions of the warehouse. So individual business license can apply for the best in advance to consult the local drug supervision department.
Three, medical device production license conditions;
1, with the production of medical devices and production sites, environmental conditions, production equipment, and professional and technical personnel;
2, the production of medical devices to carry out quality inspection of institutions or full-time inspectors and inspection equipment;
3, to ensure that the quality of medical devices Management system to ensure the quality of medical devices;
4, with the production of medical devices compatible with the after-sales service capacity;
5, in line with the product development, production process documentation requirements;
6, has obtained the second and third medical device product registration certificate, has been in accordance with the relevant provisions of the industrial and commercial registration;
7, has been established in accordance with the requirements of the Code of Practice for the Production of Medical Devices quality management system. The requirements of the establishment of medical device production quality management system;
8, for the production of medical devices license applications for personnel with appropriate professional knowledge, familiar with the production of medical devices and quality management of laws, regulations and technical requirements.