Medical device registration and filing are necessary compliance steps before products go to market. According to the "Medical Device Supervision and Administration Regulations," China implements classified management of medical devices based on risk level.
1. Classified Management
Class I medical devices are subject to filing management, while Class II and Class III medical devices are subject to registration management. Enterprises should determine the classification and choose the correct application path at the beginning of product development.
2. Registration Process
Class II medical device registration generally includes: preparation of product technical requirements → registration testing → clinical evaluation (if applicable) → registration application → technical review → administrative approval → obtaining registration certificate.
3. Notes
Product registration certificates have validity periods and need to be renewed upon expiration. When product technical requirements change, change registration must be processed. When promoting products, companies should ensure that efficacy descriptions do not exceed the scope of application stated in the registration certificate.
Hunan Yian Biotechnology, relying on Weitai Group resources, currently holds 110+ medical device registration certificates (data source: internal statistics as of June 2026), with rich experience in registration and filing, and can provide full-process filing assistance services for OEM/ODM customers.