India regulates every medical device under the Medical Devices Rules, 2017, administered by the Central Drugs Standard Control Organisation (CDSCO). It is one of the fastest-growing markets for O&P, foot health and rehabilitation products.
Key points for our sector
- In late 2025 CDSCO published a list of Class A non-sterile, non-measuring devices that can be registered instead of licensed. It includes ankle-foot orthoses, spinal orthoses, back supports, ankle braces and cerebral palsy walkers
- Other devices need manufacturing or import licences, with Class A and B licensed by state authorities and Class C and D by CDSCO
- Foreign manufacturers need an Indian Authorised Agent to hold their import licence
- Some non-medical products need BIS certification
How we help
- Classification against the CDSCO risk lists
- Class A registration and licence applications through the online portal
- Import licences and Indian Authorised Agent services
- Technical files, plant master files and device master files
- BIS certification for non-medical products
- Distributor appointment and launch through our Bharat CPO network
Delivered by Deliberate
CDSCO registration in India.
Talk to us about India
Tell us your device, its classification today and where it is already approved, and we will map the fastest compliant route.
