According to the Regulations on the Supervision and Administration of Medical Devices, the following conditions are required to apply for the production license of Class II medical devices:
(1) Having a production site, environmental conditions, production equipment and professional technicians suitable for the medical devices produced;
(2) Having a quality inspection institution for medical devices produced or full-time inspectors and inspection equipment;
(3) Having a management system to ensure the quality of medical devices;
(4) Having the ability of after-sales service suitable for the medical devices produced;
(five) the requirements specified in the product development and production process documents.