Is It Necessary To Carry Out Virus Inactivation Verification In A Qualified Laboratory For Medical Devices Of Animal Origin?

Risks vary in different animal sources, production processes and applicable products. For some common virus inactivation processes, such as organic matter, radiation, strong acid, etc., the processes and methods are relatively mature which have many references. Therefore, it is not necessary to carry out laboratory verification one by one. Instead, it can be considered to refer to biological evaluation, immune prototype evaluation, clinical evaluation and other methods, and replace them with literature and historical data. Regarding qualification, there are no relevant provisions in the current medical device regulations.