To Evaluate The Virus Inactivation Effect, Whether The Animal-based Medical Devices Must Be Subject To Laboratory Validation Of Virus Inactivation Process？

According to Guidelines for Technical Review of Animal-based Medical Device Registration (2017 Revision), to apply for the registration of animal derived medical devices, the description of the process of inactivating and removing viruses and / or infectious factors in the production process and the effectiveness verification data or relevant materials shall be provided.

The efficacy of virus inactivation can be validated through laboratory validation or from suppliers of animal-derived materials, or evaluated through literature or historical data. If the validation data submitted are not based on the data obtained from the validation of the declared product itself, an analysis and demonstration of its applicability shall be conducted