Does the Surgical Microscope Sterile Protective Cover have to be a Class 2 medical device?

The Surgical Microscope Sterile Protective Cover is a device product used for the protection and sterility requirements of surgical microscopes. According to the Classification Catalog of Medical Devices issued by the State Food and Drug Administration of China, medical devices are classified into three categories according to their risk level, i.e. Class 1, Class 2 and Class 3 medical devices.

Based on your description, surgical microscope aseptic protection sleeves are auxiliary devices used to protect and maintain surgical microscopes, and therefore generally belong to Class 2 medical devices.Class 2 medical devices are relatively low-risk, and need to comply with the relevant medical device quality management system and production standards, but the registration and filing requirements are relatively simplified.

However, please note that specific medical device classification and regulatory requirements may vary depending on the regulations and standards of different countries or regions. Therefore, the exact classification and requirements should be referred to the local regulations and regulatory agencies.