In the Chinese market of medical devices, there is a lot of beauty filling products which is used to fill the face to replace lost contours, thus plays a role in plastic and aesthetic surgery. The products are implanting medical devices with high-risk, and belong to key regulatory targets by CFDA, so there is high requirements to supervision of beauty filling products such as hyaluronic acids in the registration, manufacture, distributing and use.
CIRS make a summary about how to address the regulatory in the registration, manufacture, distributing and use according to years of experience of medical device registration.
CIRS make a summary about how to address the regulatory in the registration, manufacture, distributing and use according to years of experience of medical device registration.
Part 1
Classification and Data Requirement of beauty filling product such as hyaluronic acids
- Guiding principle
- 《Guiding principle of the data of the application and registration of passive implantation and animal derived medical devices》
- 《Clinical trial basic requirements of Sodium Hyaluronate facial filling material by injection》
- Classification and Basic Information
- Classification
- Registered unit Division
- Registration processes and requirements
- Requirement of Application materials