Medical device manufacturers do not need a business license. According to the relevant provisions of the medical device manufacturer in its production address sales of medical devices, do not need to apply for a business license or record; in other places of storage and spot sales of medical devices, should be in accordance with the provisions of the business license or record.
Legal objective:"Supervision and Administration of Medical Devices Regulations" Article 30 engaged in the production of medical devices, shall have the following conditions: (a) with the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment and professional and technical personnel; (b) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment (C) have to ensure the quality of medical devices management system; (D) with the production of medical devices compatible with the after-sales service capabilities; (E) in line with the product development, production process documentation requirements.