1, a lot of drugs or medical equipment dealers, if there is no three types of medical equipment business license, many products can not be sold, such as in vitro diagnostic reagents belong to the three types of medical equipment, only have the relevant certificate, you can sell this kind of product. 2, to apply for the three types of medical equipment business license, there must be a relevant business license, general business license On the business scope of this column, need to clearly write that can sell class III medical devices. If not, you need to go to the Trade and Industry Bureau for additions. 3, the sale of Class III medical devices, you must have their own warehouse, and the warehouse needs to be set up in the refrigerated warehouse, because Class III medical devices, there is a need for insulation, more than a certain temperature, it is easy to deteriorate and affect the quality of the product, so very few dealers have the qualifications of the sale of Class III medical devices. 4, to go to the Trade and Industry Bureau for additions, it is necessary to take with the Trade and Industry Bureau Staff to check the warehouse, you'd better clean up the warehouse, and then get the "medical device business license application form" and fill out, and bring all the relevant qualifications of the enterprise, but also need to bring the relevant information of the quality personnel. 5, Class III medical device business license, you need to go directly to the municipal people's government food and drug supervision and management department for the 30 days after accepting the information for audit, if comply with the relevant provisions, you can issue a license to operate three types of medical devices.
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 testing of the organization or full-time inspectors and testing equipment ; (C) have to ensure that the quality of medical devices management system; (D) with the production of medical devices compatible with the after-sales service capacity; (E) in line with the product development, production process documentation requirements.