By Naraway
In this article
In FY25, India bought about US$8.6 billion of medical devices from abroad and sold US$4.1 billion. Close to 60% of the imports were electro-medical equipment: imaging, monitoring and surgical systems India does not yet make at scale.
For an overseas device maker, that gap is the opportunity. The path into it is one of the most regulated in Indian trade.
Sources: industry report via Tribune India (February 2026); MedDeviceGuide, citing CDSCO and Pharmexcil data.
Four Letters Decide the Route
Class A
Low risk, such as bandages and thermometers. Imports still need a CDSCO licence.
Class B
Low to moderate risk, such as infusion sets and some diagnostic equipment.
Class C
Moderate to high risk, such as ventilators and many imaging systems. Licensed by CDSCO.
Class D
High risk, such as implantable devices. Licensed by CDSCO, with the longest review.
Classes under the Medical Devices Rules, 2017. Examples are typical; classification depends on the device and its intended use.
For devices made in India, state authorities license Class A and B and CDSCO licenses Class C and D. For imports the split disappears: every class goes to CDSCO through its SUGAM portal, and the overseas manufacturer applies through an authorised agent in India.
How Long It Takes
CDSCO does not publish a single service time, and estimates vary. Consultancies put Class A and B approvals at three to six months and Class C and D at six to nine, with some advising 12 to 18 months of planning before a high-risk device reaches the Indian market. Classification, test reports, the agent's licence and the quality system documents all have to line up before the clock starts.
Two Estimates of the Same Gap
How dependent India is on imports depends on who counts. An industry report published in February 2026 puts imports at 70% to 80% of demand. An analysis of CDSCO and Pharmexcil data for FY2025-26 puts it at 62%, noting that consumables, where Indian makers compete, pull the share down. On high-end equipment, both agree the dependence is far higher.
Why Device Makers Are Moving In
India's market is projected to reach US$50.1 billion by 2030, and the government is pushing hospitals, insurance coverage and local manufacturing at the same time. For makers of high-end equipment, that means demand that Indian production will not meet for years.
Which class a device falls in, who should act as the authorised agent, what the dossier needs, and whether to import or eventually manufacture in India decide both the timeline and the cost. Classification alone is where many applications lose their first months.
Part of Naraway's research series India Market Entry in 2026.
In short
Every medical device imported into India needs a licence from the Central Drugs Standard Control Organisation (CDSCO), applied for on the SUGAM portal, whatever its risk class. Devices are classed A (low risk) to D (high risk) under the Medical Devices Rules, 2017; domestic Class A and B manufacturing is licensed by state authorities, while Class C and D and all imports go to CDSCO. India imported about US$8.6 billion of medical devices in FY25 against US$4.1 billion of exports, and consultancies put import approval at three to nine months, longer for Class C and D.
- FY25: US$8.6 billion of medical device imports, US$4.1 billion of exports.
- Imports meet 62% to 80% of Indian demand, depending on the estimate.
- Every imported device, Class A to D, needs a CDSCO import licence.
- Electro-medical equipment is close to 60% of imports.
- The market is projected to reach US$50.1 billion by 2030.
Sources
- India's medical devices industry to reach USD 50.1 billion by 2030: Report, Tribune India
- India CDSCO medical device market: approved devices analysis 2026, MedDeviceGuide
- CDSCO medical device licence and import registration, Treelife
- CDSCO registration: how to bring your medical device to India, Qualio
Frequently Asked Questions
Do imported medical devices need registration in India?
Yes. Every imported medical device, from Class A to Class D, needs an import licence from CDSCO before it can be sold or distributed in India.
What are the medical device classes in India?
Class A (low risk), Class B (low-moderate), Class C (moderate-high) and Class D (high risk), under the Medical Devices Rules, 2017.
Who approves medical devices in India?
State licensing authorities handle Class A and B devices manufactured in India. CDSCO handles Class C and D manufacturing and all imports, through the SUGAM portal.
How long does medical device registration take in India?
Consultancy estimates range from three to six months for Class A and B to six to nine months for Class C and D, with some advising 12 to 18 months of planning for high-risk devices.
How big is India's medical device market?
India imported about US$8.6 billion of devices and exported US$4.1 billion in FY25. The market is projected to reach US$50.1 billion by 2030.
