Chapter – III
Authorities, Officers and Bodies
In India, depending on the class, the medical devices are regulated by Central Licensing Authority and State Licensing Authority
Central Licensing Authority
The central licensing authority is the competent authority for the enforcement of these rules in relation to:
1. Import of all classes of medical devices
2. Manufacture of Class C and D medical devices
3. Clinical investigation and approval of medical devices
4. Clinical performance evaluation and approval of new in vitro diagnostic medical devices, and
5. Co-ordination with state licensing authorities