CDSCO vs State Licensing Authority — Who Regulates?
India's medical device regulation operates across two tiers: the Central Drugs Standard Control Organisation (CDSCO) at the national level and State Licensing Authorities (SLAs) at the state level. Understanding which authority regulates your product is essential before applying for any licence.
CDSCO — Central authority
CDSCO, under the Ministry of Health & Family Welfare, is responsible for:
- Import licences for all notified medical devices (Class A, B, C, D);
- Manufacturing licences for Class C and Class D devices (higher-risk);
- New drug and clinical investigation approvals;
- Market surveillance and enforcement at the national level;
- Policy, guidance, and MDR 2017 administration.
CDSCO's licensing decisions are made by the Central Licensing Authority (CLA), headed by the Drugs Controller General of India (DCGI).
State Licensing Authorities (SLAs)
SLAs operate under respective State/UT drug control departments and handle:
- Manufacturing licences for Class A and Class B devices (lower-risk);
- Wholesale dealer and retail licences for devices within their state;
- GMP inspections for Class A and Class B manufacturers;
- Market surveillance within the state.
Quick reference: who approves what
| Activity | Authority |
|---|---|
| Import licence — all classes | CDSCO (CLA / DCGI) |
| Manufacturing licence — Class A | State Licensing Authority (SLA) |
| Manufacturing licence — Class B | State Licensing Authority (SLA) |
| Manufacturing licence — Class C | CDSCO |
| Manufacturing licence — Class D | CDSCO |
| Clinical investigation permission | CDSCO |
| Vigilance reporting | CDSCO (MDVP) |
| Wholesale / retail licence | SLA |
SUGAM portal — single submission point
All import and CDSCO-level manufacturing licence applications are submitted online through the SUGAM portal (sugam.cdsco.gov.in). SLA applications may vary by state.
The split between CDSCO and SLA jurisdiction is a uniquely Indian feature. Overseas manufacturers need CDSCO approval for import; the SLA split mainly affects domestic manufacturers of lower-risk devices.