Every medical device and IVD sold in India is regulated under the Medical Device Rules, 2017. A foreign manufacturer cannot hold an Indian licence directly — you need the right risk class, an Authorised Indian Agent, a dossier built for CDSCO (not copy-pasted from your CE or FDA file), and a post-market plan. Launch Rocket runs all of it, end to end.
Your risk class decides your licensing authority, your evidence burden, your fees and your timeline. The same product sold in Korea, the EU or the US can sit in a different class in India — and filing in the wrong class doesn't just get rejected, it burns months.
Typical devices: Tongue depressors, bandages, surgical gloves, non-sterile basic instruments
Non-sterile & non-measuring Class A devices follow the lighter registration route; sterile or measuring Class A devices still need a licence.
Typical devices: Hypodermic syringes, blood-pressure monitors, digital thermometers, certain hearing aids
Full licence route. Dossier depth increases; labelling and IFU scrutiny begins in earnest.
Typical devices: Ultrasound imaging, orthopaedic & spinal implants, haemodialysis machines, infusion pumps
Central Licensing Authority route with Subject Expert Committee review. Clinical evidence and risk management file are decisive.
Typical devices: Drug-eluting cardiac stents, cochlear implants, surgical robotic systems, high-risk IVDs
The most demanding pathway — full clinical investigation data or robust published evidence, sterilisation validation and biocompatibility.
Classification is determined by intended use and risk under the Medical Device Rules, 2017 — not by how the device is marketed elsewhere. CDSCO has been tightening this: separate risk-classification application routes now exist for medical devices and for IVDs, and licences are not issued against unclassified devices. We settle the class in writing before a rupee is spent on the dossier.
The import route runs on Form MD-14 (application) to Form MD-15 (licence), filed with the Central Licensing Authority through the CDSCO online portal. Manufacturing in India runs a parallel track.
Determine risk class and regulatory pathway under MDR 2017 — confirmed in writing, with the reasoning.
A CDSCO-recognised Authorised Indian Agent holding a valid wholesale licence, empowered by Power of Attorney.
Device Master File, Plant Master File, Free Sale Certificate, ISO 13485, risk management, labelling & IFU — adapted for India.
Submission on the CDSCO portal, then query and deficiency-letter handling — including Subject Expert Committee review for Class C/D.
Import licence granted. It stays valid in perpetuity — provided the retention fee is paid before each five-year milestone.
MDR labelling plus Legal Metrology declarations, then customs clearance against the licence — with the right HS code.
Wholesale and sale licensing for your distribution chain, hospital empanelment and tender documentation.
Post-market surveillance, adverse-event reporting under the Materiovigilance Programme, recalls, variations and renewals.
Under MDR 2017 a foreign manufacturer cannot hold an Indian import licence directly. The licence is applied for and held through an Authorised Indian Agent who holds a valid wholesale licence. That makes your choice of agent one of the most consequential commercial decisions in your India entry — because in practice, whoever holds the licence holds your market access.
The single most common cause of long review cycles is a Device Master File lifted straight from a CE or FDA submission. Indian reviewers read the whole story at once: classification, intended use, model numbers, manufacturer address, labelling, validation and post-market evidence. Any inconsistency between them becomes a query, and every query costs weeks.
Risk class, licensing route, predicate landscape and a costed roadmap before you commit budget.
Compliance-first agent arrangements, Power of Attorney, and a structure that keeps your licence portable.
Device and Plant Master Files, Free Sale Certificate, ISO 13485 mapping, MD-14 filing and query defence.
MDR 2017 labelling plus Legal Metrology declarations — handled with Product Label Guru so customs and buyers both accept it.
Correct HS classification and landed-cost modelling via TariffProof, plus test licences for demo and evaluation units.
Surveillance, adverse-event reporting, recalls, licence variations and retention-fee tracking so nothing lapses.
Indian hospitals, distributors and procurement teams carry real exposure when they buy unregistered devices. Dealing in a medical device without the required licence is an offence under India's drugs and medical-device law — and the paperwork you were shown is not always the paperwork that exists.
What actually stalls global medtech at India's border — and how the rules around it are moving.
Your device cleared MFDS, CE and FDA — and CDSCO still sent a deficiency letter. The five traps that stall global medtech at India's border: wrong risk class, a copy-pasted Device Master File, an agent who owns your licence, dossier inconsistency, and the post-market clock nobody diarised.
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Read articleNo. Under the Medical Device Rules, 2017, a foreign manufacturer must act through an Authorised Indian Agent who holds a valid wholesale licence and is empowered by Power of Attorney. The agent files Form MD-14, holds the resulting Form MD-15 import licence, answers CDSCO queries and carries post-market responsibilities. Choosing that agent well is critical — in practice, whoever holds the licence controls your market access.
All medical devices and IVDs are now regulated. Broadly, Class A devices that are non-sterile and non-measuring follow the lighter registration route, while Class A sterile or measuring devices and all Class B, C and D devices require a full import licence in Form MD-15. Because the exemption is narrow and hinges on sterility and measuring function, we confirm it in writing rather than assuming it.
It depends on risk class and, far more than most brands expect, on dossier quality. Import-licence review commonly runs several months; Class C and D take materially longer because they go through Subject Expert Committee evaluation. Preparing the technical file itself typically takes months before filing. The biggest controllable variable is how many query cycles you trigger — a consistent, India-adapted dossier is the single best way to shorten the calendar. We give a product-specific timeline after classification.
The import licence remains valid in perpetuity — but only so long as the licence retention fee is paid before the completion of each five-year period from issue. Miss it and CDSCO can suspend and ultimately cancel the licence. It is an unglamorous diary entry that has cost brands their market access; we track it for you along with variations and renewals.
They help as evidence — and they are expected in your pack — but they are not a substitute for Indian approval, and they do not decide your Indian risk class. A device that is Class II elsewhere can sit in a different class here, because classification follows intended use and risk under MDR 2017. Submitting a CE or FDA file unchanged is the most common reason a technically excellent device collects deficiency letters.
Yes — through a test licence, which permits import of limited quantities for demonstration, evaluation, testing or clinical investigation. It is a distinct application from your commercial import licence and is often the smart first move for building clinician confidence and tender references while the main licence is under review.
Send us your device, its intended use and your existing approvals. We'll confirm the Indian risk class, map the licensing route with realistic timelines and costs, and run the filing and post-market compliance end to end.