May I ask if in vitro diagnostic reagents belong to the category of medical devices?

In vitro diagnostic reagents are categorized into in vitro diagnostic reagents managed as pharmaceuticals and in vitro diagnostic reagents managed as medical devices.

In vitro diagnostic reagents managed as medical devices need to comply with the "Good Manufacturing Practice for Medical Devices"

In vitro diagnostic reagents need to be treated specially because of their different characteristics from other similar products, so separate regulations have been made for each aspect of in vitro diagnostic reagents.

It is not only for the product registration system assessment.