I will register your medical device with cdsco, class a to class d


About this gig
Medical device registration in India isn't one process it changes based on what your device does and what class it falls under.
Class A NSNM devices need a straightforward registration. Class A sterile and measuring, Class B, C, and D devices go through a more detailed evaluation technical dossier, performance data, clinical evidence, and in higher classes, a full CDSCO review before any license is issued. SAMD and SiMD products add another layer, since software-specific documentation requirements apply.
I work across all four classes for both importers and domestic manufacturers device classification, technical file preparation, authorized agent setup for foreign manufacturers, MD-14/MD-15 or manufacturing license filing, and query management through to approval.
Most problems I fix trace back to three things: wrong classification at the start, a technical file that doesn't match CDSCO's expectations for that class, or queries that go unanswered or are answered poorly. I review all of this before filing.
Tell me your device name and intended use before ordering classification comes first, everything else follows from it.
Get to know Devansh K
Regulatory Affairs Consultant, CDSCO, FSSAI ,Medical Device Licensing Expert
- FromIndia
- Member sinceJun 2026
- Avg. response time1 hour
Languages
Hindi, English
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FAQ
How do I know which class my device falls under?
Classification depends on intended use, risk, and whether the device is sterile or measuring. Don't assume — message me with the product details and I'll confirm before you order.
Do imported and domestically manufactured devices follow the same process?
Same classification, different forms and requirements. Imports go through MD-14/MD-15 with an authorized agent; domestic manufacturers apply for a manufacturing license. Both need proper technical documentation.
What is SAMD and does my software product qualify?
Software as a Medical Device means software that performs a medical function on its own — diagnostic apps, clinical decision tools, monitoring software. If your product might qualify, mention it when you message me.
Can you handle devices across multiple classes in one order?
Each device and application is separate. If you have multiple products, contact me before ordering and I'll advise on the most efficient approach.

