Selling medical devices in India:
two tracks, not one
The regulatory track is licensed, sequential and slow, and you cannot buy your way past it. The commercial track is neither, and almost nobody plans for it until the licence arrives and nothing sells. Here is how they fit together.
Do I need an India authorized agent or a sales partner?
Both, and they are different people doing different jobs. The regulatory track is licensed. A foreign manufacturer must appoint a single India Authorized Agent, who holds the applicable wholesale licence, manufacturing licence or Form MD-42 registration, who is given a Power of Attorney, and who applies on your behalf through the CDSCO online portal in Form MD-14. CDSCO then issues the import licence in Form MD-15, which customs checks at clearance. That agent is your legal interface with the regulator, and nobody can shortcut it.
The commercial track is not licensed at all: finding and screening distributors, reaching the hospitals and diagnostic chains who will actually buy, pricing and positioning for India, and running the sales motion. Montazzo runs the commercial track. We are not an India Authorized Agent. We do not hold MD-15, MD-42, 20B or 21B. We do not file with CDSCO, clear customs, import, warehouse or take title to goods. If a firm offers you both tracks in one contract, ask whose name is on the licence.
By Tanveer Sinngh, Founder at Montazzo · What does the regulatory track actually involve?
Under the Medical Device Rules 2017, importing a medical device into India runs through a defined sequence, and the order matters.
| Step | What it is | Who holds it |
|---|---|---|
| Appoint the India Authorized Agent | A Power of Attorney from the foreign manufacturer to a single Indian entity, who becomes the legal liaison with the regulator. | You grant it. The agent must be an Indian entity. |
| Agent's own licence | The agent must already hold the applicable wholesale licence, manufacturing licence, or Form MD-42 registration before the import application can proceed. You cannot file both at once. | The agent. Ask for the number and verify it. |
| Form MD-14 | The application for an import licence, filed on the CDSCO online portal with the device dossier, free sale certificates, quality certifications and plant master file. | Filed by the agent, on your behalf. |
| Form MD-15 | The import licence itself, issued by CDSCO. This is the document that lets the device into the country. | Issued in the agent's name, for your device. |
| Customs and labelling | At clearance, customs verifies the validity of the MD-15 and that labelling complies with the Medical Device Rules. | The importer of record. |
Risk classification matters throughout. Devices are classified A, B, C or D, and the class drives the fee, the depth of review and which documents the dossier must carry. The official source for the forms, classification lists and current fees is CDSCO, and the filing itself runs through its online portal. Do not take a consultancy's summary of the requirements, including this one, as the authority for what to file.
How long does the regulatory track take?
Honest answer: nobody can tell you, and the firms quoting you a fixed number of months are estimating. CDSCO does not publish a guaranteed processing time for an import licence. What is published, and what practitioners agree on, is that the duration depends on three things: the risk classification of the device, how complete the dossier is on first submission, and how fast the applicant answers queries once review begins.
That third variable is the one that actually determines your timeline. Each query cycle adds weeks, and a dossier that generates three rounds of queries will take far longer than one that generates none. The practical lesson is that time spent getting the dossier right before filing is cheaper than time spent responding after.
Your import licence is tied to the India Authorized Agent you appointed. CDSCO guidance indicates that changing your Indian agent requires a fresh import licence, which means a distributor decision you made in month one can cost you the whole registration timeline in month twenty if it turns out to be wrong.
That is the single strongest argument for screening your channel properly before you appoint anyone. Our twelve-point distributor screen exists for exactly this reason, and in regulated categories it is worth running before the licence process starts rather than after.
What does the commercial track involve?
This is the half that gets no planning, and the half that decides whether the licence was worth getting. Four jobs.
- Channel mapping and screeningWhich importers and distributors already move devices in your category, in which cities, with what service capability, and which competing lines they carry. Then the screen, because a distributor who holds your licence and sells nothing is worse than no distributor at all.
- Demand generation into the end buyerOutbound into hospitals, hospital chains, diagnostic chains, clinic groups and specialist centres, run from Indian sending infrastructure and in Indian business hours. The point is that your distributor inherits live opportunities instead of a product catalogue.
- Pricing and positioning for IndiaUsually not a discount. A different configuration: different warranty terms, a local service tier, consumable pricing separated from capital, or a longer contract. We bring back the objection in the buyer's words so you can decide what to change.
- The sales motionQualification, follow-up that does not stop at email two, committee navigation inside the hospital, and loss reasons written down so year two is not a repeat of year one.
On the demand side specifically, we have a working hospital, clinic and diagnostic network in India. That is covered on its own page: our India hospital and clinic network.
Who actually decides to buy a device in an Indian hospital?
Never one person, which is why device sales here take four to nine months rather than four to nine weeks. Five roles matter and they want different things.
- The clinical champion. A consultant or head of department who wants the device because it changes what they can do. No purchase happens without one, and nothing you say to procurement substitutes for it.
- Biomedical engineering. Owns installation, uptime, calibration, spares and whether your service story is real. This is where foreign vendors lose deals they thought they had won, because the honest answer to "who fixes it in Coimbatore on a Sunday" is nobody.
- Procurement or materials management. Owns the process, the comparison, and whether you are even allowed to be in the comparison. Cares about documentation, about whether you have an authorised distributor with manufacturer backing, and about price.
- Finance or the CFO. Owns capital allocation and increasingly wants the device as an operating cost rather than a capital one. Consumable-linked and pay-per-use structures have become normal.
- The medical superintendent or hospital director. Signs, arbitrates between the clinical champion and finance, and in chains may be constrained by a group-level purchasing policy you need to know about before you start.
In the large private chains, add a group procurement function above all of these, with an approved-vendor list that a single hospital cannot override. Getting on that list is a separate campaign from selling to any one hospital, and it is worth running first.
What about government tenders and GeM?
Public sector hospitals and medical colleges buy through tender, and most central government procurement now runs through the Government e-Marketplace. Four things to know before you decide whether that channel is worth your time.
- The purchase value determines the method. Small purchases can be made directly; larger ones require a full competitive tender with the item listed on the marketplace. The bands are set by the government's financial rules and change, so check the current thresholds rather than relying on any summary, including this one. The authority is GeM.
- You usually cannot bid as a foreign manufacturer. Tenders are typically written to require the manufacturer or an authorised distributor with documented manufacturer support. Your channel decision therefore determines your access to the public market, not just your private-sector reach.
- Local content preference applies. Under the Preference to Make in India framework, suppliers are grouped into tiers by local content, and higher local content can win a bid that is not the lowest price. For a fully imported device this is a structural disadvantage, and it is worth knowing the size of it before you build a public-sector plan.
- Earnest money and documentation are real barriers. Deposits, performance guarantees and document sets are substantial, and bids are routinely rejected on technical compliance rather than on price or product.
Our own view, which you are free to disagree with: for most foreign manufacturers entering India, the private hospital and diagnostic chain market is the better first target, and public tender is a year-two channel once you have an Indian partner who has done it before.
Where the margins sit, and why that is changing
Device and consumable trade margins in India are under active regulatory review, and if you are signing a distribution agreement now you should write it with that in mind.
State drug regulators have documented markups on hospital consumables running into the hundreds and in some cases thousands of percent between the distributor's purchase price and the amount billed to the patient. The national pricing authority has already capped trade margins on certain non-scheduled medicines at thirty percent, industry associations are pressing for a single framework rather than ad-hoc caps, and several state governments have floated their own margin rules. Nothing here is settled.
What that means practically: ask your distributor what margin they need and what they do with it, and make sure the commercial terms survive a cap being introduced mid-agreement. A partner whose entire economics depend on an unregulated spread is a partner whose economics may change without either of you choosing it.
What Montazzo runs, stated plainly
We do: channel mapping and distributor screening, demand generation into hospitals, clinics, diagnostic chains and distributors, market and competitor research, pricing and positioning input, and the India sales motion once a regulatory partner is in place.
We do not: act as your India Authorized Agent, hold MD-15, MD-42, 20B or 21B, file anything with CDSCO, handle registration or customs clearance, import, warehouse, or take title to your goods. We do not give regulatory or legal advice, and this page is not any.
Use a licensed regulatory consultant or your appointed agent for the first track. We will tell you where the two tracks collide, because the agent you appoint for the licence is frequently the wrong company to sell your product, and that conflict is better discovered now.
Related: the overview of entry routes into India, the distributor screen, and the hospital network that creates demand.
FAQ
Questions medical device manufacturers ask us
Yes, and it is extremely common, which is exactly why it deserves thought. The same company holding your licence and your channel is convenient until the channel underperforms, because changing the agent can require a fresh import licence. Some manufacturers deliberately appoint a neutral regulatory agent and keep distribution separate so the two decisions can be unwound independently. Which structure is right depends on your category, and it is a decision to make before filing, not after.
There is no published guaranteed timeline, and we will not invent one. The duration depends on the risk class of the device, how complete your dossier is on first submission, and how quickly you answer queries during review. Query cycles are what stretch timelines, so the single highest-leverage thing you control is dossier quality before filing. Treat any firm quoting you a fixed number of months as giving you an estimate rather than a commitment.
No. We are a commercial sales and demand generation team. We do not hold any licence, we do not file with CDSCO, and we are not your authorized agent. We work alongside whoever does that job, and we will often start work during the regulatory process so that demand exists on the day the licence lands rather than six months after.
Yes, and in most cases you should. Channel mapping, distributor screening and early demand generation into hospitals can run during the regulatory process, so the licence arrives into a live pipeline instead of an empty one. What we will not do is take orders or make claims that imply the device is approved for sale before it is.
A committee. A clinical champion who wants the device, biomedical engineering who judge whether you can support it, procurement who control the comparison, finance who control the capital, and a medical superintendent or director who signs. In the large private chains a group procurement function sits above all of them with an approved-vendor list that individual hospitals cannot override. Expect four to nine months and expect to lose deals on service capability rather than on product.
Usually not as a first channel. Public tenders typically require the manufacturer or an authorised distributor with documented manufacturer backing, local content preference works against a fully imported device, and bids are frequently rejected on technical documentation rather than on merit. Private hospitals and diagnostic chains are a faster first market, and public tender becomes realistic once you have an Indian partner who has won them before.
Service, then price, in that order. The question that sinks deals is who physically repairs the device, how fast, and where the spares sit. A credible answer involving named engineers in named cities is worth more than a price cut. On price, the productive move is usually to restructure rather than discount: separate consumables from capital, offer a service tier, or move to a usage-linked model.
Tell us where your device is in the process
A 30-minute call. We tell you what the commercial track looks like for your category, what your channel options are, and which parts you need licensed people for.
Let's chat