IN
A four-class system on GHTF principles, where the class decides which authority licenses the device — and that changes the timeline more than the paperwork does.
India classifies under the Medical Devices Rules 2017, using four classes labelled A to D on GHTF principles. The rules themselves will read as familiar to anyone who knows Annex VIII. The consequence attached to them will not: the class determines whether the state licensing authority or the central licensing authority handles the application. Classes A and B go to the state authority, Classes C and D to the central one, and the difference in practice is measured in months. In most markets the class changes how much evidence you assemble; here it also changes who you are dealing with.
Classes A to D, the same letters the IVDR uses for in vitro diagnostics in Europe and a different scale from either. A is lowest and D is highest. There is no correspondence with EU Classes I to III beyond the shared intuition that higher means riskier.
| CLASS | RISK | INDEPENDENT REVIEW |
|---|---|---|
| A | Low | State licensing authority |
| B | Low-moderate | State licensing authority |
| C | Moderate-high | Central licensing authority |
| D | High | Central licensing authority |
Under the Medical Devices Rules 2017, in four classes A, B, C and D, following GHTF principles. Class A is the lowest risk and Class D the highest.
Because it decides which authority licenses the device. Classes A and B are handled by the state licensing authority and Classes C and D by the central licensing authority, which changes timelines substantially.
There is no engine for this market yet. Tick it in the questionnaire anyway — it is counted, and we build in the order people ask.
