On November 23, CFDA issued official Guidelines on Medical Device Registration Unit Classification, which mainly focus on the technical principles, structural components, performance indexes, scope of application and packaging specifications of in vitro diagnostic reagents.
This release includes guidelines for active medical devices, non-active medical devices and in vitro diagnostic reagents and lists examples of registration unit delineation. Some of these guidelines require a combination of relevant guidelines or criteria for examination of registered technology .
The guiding principles are based on the actual situation of the current medical device registration declaration formulated with the constant improvement of the legal system, the continuous development of science and technology and the improvement of the cognitive level, the relevant content of these guidelines will also be adjusted in due course.
The guidelines contain the following sections:
- The active medical device registration guidelines
- The non-active medical device registration guidelines
- In vitro diagnostic reagents registration guidelines
- Attachment: medical device registration unit classification examples