New Device vs Already-Approved Device Routes
Two routes for import licence
CDSCO applies a two-track approach to Class B, C, and D device import licence applications:
Track 1 — Already approved by a reference authority
If the device holds a valid approval from one of CDSCO's reference regulatory authorities:
- US FDA (510(k), De Novo, or PMA)
- EU (CE marking under EU MDR or legacy MDD)
- Australia TGA
- UK MHRA
- Canada Health Canada
- Japan PMDA
…then the applicant may be eligible for:
- Reduced clinical data requirements (bridging study instead of full Indian clinical investigation);
- Faster review timelines;
- Simplified technical documentation referencing the reference authority approval.
Track 2 — New device (no reference approval)
If the device does not hold a reference approval, or is a novel technology:
- Full clinical data from an Indian or internationally accredited clinical investigation may be required;
- Longer review timelines apply;
- Full technical documentation package is required.
How to claim the reference pathway
- Include a copy of the reference authority approval (FSC/510(k)/CE DoC) in the SUGAM application;
- Provide a statement comparing the reference country's regulatory requirements with India's;
- Submit a bridging assessment confirming the device meets Indian GMP, labelling, and essential principles requirements.
CDSCO retains discretion to require additional data even for already-approved devices if public health considerations warrant it.