This issue involves regulations concerning the sale of medical devices. According to the *Regulations on the Supervision and Administration of Medical Devices*, selling medical devices does indeed require corresponding qualifications.
Overview of Qualification Requirements: Selling medical devices, whether Class 1, Class 2, or Class 3, requires obtaining the corresponding sales qualifications or registration.
The qualification requirements differ for different categories of medical devices.
Specific Requirements for Sales Qualifications for Various Types of Medical Devices:
Class 1 Medical Devices: A business license is not required to sell Class 1 medical devices, but registration with the drug regulatory authority of the municipal-level people's government where the business is located is mandatory.
Class 2 Medical Devices: Registration with the food and drug administration authority of the municipal-level people's government where the business is located is required, along with compliant supporting documents, such as a quality management organization or personnel, storage facilities, storage conditions, and a quality management system.
Class 3 Medical Devices: The conditions for selling Class 3 medical devices are more stringent. Operators must apply for a business license from the food and drug administration authority of the municipal-level people's government where they are located and submit compliant supporting documents, including but not limited to a business license, warehouse setup certificate (including cold storage), and medical device business license.