Start with risk classification
Every CDSCO pathway begins with one question: what risk class is your device? India classifies devices and IVDs into four risk classes — A (lowest), B, C, and D (highest). The class decides which authority handles your file and which form you submit.
- Class A & B → State Licensing Authority
- Class C & D → Central Licensing Authority
- Import of any class → Central Licensing Authority (Form MD-14 → MD-15)
Regulatory
Import vs. manufacturing
If you are bringing a finished device into India, you are on the import track and will need an Authorised Indian Agent to hold the licence. If you are making the device in India, you are on the manufacturing track (MD-5 for Class A/B, MD-9 for Class C/D).
The single most expensive mistake we see is applying on the wrong track. Confirm your classification before a single dossier page is written.
A simple decision sequence
- Confirm the risk class against the CDSCO notified-device list.
- Decide import vs. manufacture based on where the device is finished.
- Map the correct form, then build the dossier around its checklist.
Get these three right and the rest of the journey — queries, audits, endorsements — becomes a process rather than a surprise.