Class 3 medical device classification code 6826 need production license

Yes, the "supervision and management of medical devices regulations" Article 22: engaged in the production of Class II, Class III medical devices, the manufacturer shall apply to the food and drug supervision and management department of the people's government of the province, autonomous region and municipality directly under the Central Government for a production license and to submit its compliance with the conditions set out in Article 20 of the Regulations, as well as the production of medical devices, the registration certificate. So the production of three types of 6826 physical therapy and rehabilitation equipment need the appropriate production license and product registration certificate.