Medical Device Registration
Register or licence a medical device for manufacture, import or sale in India.
Our professional fee
Quoted on your specifics
A fixed figure in writing, before any work starts
Or call +91 98765 43210Overview
What this is
Medical devices are regulated under the Medical Devices Rules, which sort every device into risk classes. The class decides whether the state licensing authority or CDSCO handles your application and which licence you need — manufacture, import, or sale and distribution. Getting the classification right at the start matters, because it determines the route, the documentation and who you deal with.
Scope
What’s included
- Classification of your device against the risk classes in the rules
- Advice on which licence applies and whether it is a state or central application
- Compilation of the device master file and, for imports, the plant master file
- Filing on the CDSCO portal and follow-up on queries raised by the reviewer
- Support through the audit or inspection step where the class calls for one
Everything above is covered by the professional fee. Anything outside it is quoted before we start it, never after.
Who it suits
Manufacturers, importers and distributors of medical devices and in-vitro diagnostics.
If that does not describe you, say so before you commit — there is usually a lighter filing that does the job, and we would rather point you at it.
Cost
What it costs
Our professional fee
Quoted on scope
We have not published a fee for this one. What it takes varies enough with the specifics that a number here would be a guess, and a guess is the one thing a fee should never be. Tell us what you need and you get a fixed figure in writing — before any work starts, and before you owe us anything.
Government & statutory fees
At actuals
Charged separately from our fee and paid to the relevant authority. They vary by state, by authorised capital, and by the slab you fall into, so we confirm the exact figures once we know your specifics.
We do not quote the two together as one number. They are charged by different parties and only one of them is ours. You will have both figures in writing before you decide.
Process
How it runs
Scope and quote
We confirm what you actually need, what our professional fee covers, and which government fees will apply in your case — in writing, before any work begins.
Documents
We send a checklist, then review everything you send back before it goes anywhere. Most delays start with a document, not with the authority.
Preparation and filing
We prepare and file the Medical Device Registration paperwork, then track the application and respond to any queries raised on it.
Handover
You receive every acknowledgement and certificate the authority issues, along with a plain-English note on what falls due next and when.
Processing time is set by the relevant authority, not by us. We can file promptly and follow up, but the approval itself sits with the department handling it.
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AI advisor
Ask before you commit to anything.
Ask about the fee, the documents, or whether Medical Device Registration is the right filing for your situation — in plain English, and you get the answer before you get a recommendation.
The advisor gives general guidance, not binding legal or tax advice, and it does not file anything on your behalf. A chartered accountant reviews anything that matters.