What is a medical device?

A medical device is any instrument, machine, implant, or kit used to diagnose, prevent, monitor, or treat a disease or injury that works mainly by physical or mechanical means rather than as a medicine. Examples range from syringes, thermometers, and bandages to stents, heart valves, X-ray machines, ventilators, and diagnostic test kits.

Why has India depended on imported medical devices?

Modern medical equipment was first made in Europe, the United States, and Japan, and India lacked the specialised materials, electronics, precision engineering, and testing facilities needed to make advanced devices. Even today India is commonly estimated to import around 70% or more of its medical devices, especially high-end imaging equipment and implants.

AiMeD, the Association of Indian Medical Device Industry, is a national association of Indian medical device manufacturers, widely described as formed in 2002. It campaigns for policies that favour domestic manufacturing, such as a separate law for medical devices, fair import duties, and preference for Indian-made products in public purchases.

What changed in 2014 for medical devices?

In 2014 medical devices were named a focus sector of the Make in India campaign, and at the end of 2014 the government allowed 100% foreign direct investment in medical device manufacturing through the automatic route, meaning foreign companies could set up or fully own device factories in India without special government approval.

MTaI, the Medical Technology Association of India, was formed in 2015 and represents research-based medical technology companies, many of them multinational, operating in India. It works on issues such as regulation, pricing, innovation, and patient access to advanced medical technologies.

What was the Jaipur Foot?

The Jaipur Foot is a low-cost, flexible artificial foot developed in Jaipur in 1969 by orthopaedic surgeon Dr. P. K. Sethi and craftsman Ram Chandra Sharma. It lets users squat, sit cross-legged, and walk barefoot, and through the charity BMVSS it has helped well over a million people in India and other countries.

Why did India cap the prices of stents and knee implants?

In 2017 the National Pharmaceutical Pricing Authority capped the prices of coronary stents and knee implants after finding very high trade margins. Stent prices fell sharply, by around 70–85% for many products, making heart treatment much more affordable for patients.

What are the Medical Devices Rules 2017?

The Medical Devices Rules 2017, in force from 1 January 2018, created a separate risk-based system for regulating medical devices in India. Devices are grouped into Classes A, B, C, and D from low to high risk, with stricter checks for higher-risk devices. From 2020 all medical devices were brought under regulation in phases.

How did COVID-19 change India’s medical device industry?

When the pandemic began in 2020, India made very little personal protective equipment and few ventilators. Within months Indian companies were producing PPE kits in lakhs every day, making indigenous RT-PCR test kits and ventilators, and the government launched production-linked incentives and medical device parks to build domestic manufacturing.

What is the National Medical Devices Policy 2023?

The National Medical Devices Policy, approved in April 2023, sets out a plan to make India a global leader in manufacturing and innovation of medical devices, reduce import dependence, and grow the sector from around US$11 billion to about US$50 billion by 2030 through better regulation, infrastructure, research, skills, and investment.

Health Timeline

Medical Devices Timeline of India: Imported Instruments → First Indian Makers → Heart Valves & First Rules → AiMeD → 100% FDI & Make in India → Atmanirbhar MedTech

For most of its history India imported its surgical instruments, X-ray machines, and hospital equipment. Indian makers of syringes, latex products, artificial limbs, and heart valves slowly emerged, Indian manufacturers came together as AiMeD in 2002, 100% foreign investment was allowed in 2014, research-based companies formed MTaI in 2015, and the Make in India push, COVID-19, PLI, and device parks set out to make India a medical device maker.

This timeline covers imported instruments, early X-rays, Hindustan Syringes, CSIO, HLL, the Jaipur Foot, Sree Chitra and the TTK-Chitra heart valve, Aurolab lenses, device notifications from 1989 and 2005, AiMeD, Stanford-India Biodesign, Make in India, 100% FDI, MTaI, AMTZ, stent and knee price caps, the Medical Devices Rules 2017, COVID-era PPE and ventilators, PLI, medical device parks, and the National Medical Devices Policy 2023.

1969 Jaipur Foot → 1990 Chitra Heart Valve 2002 AiMeD → 2014 100% FDI → 2015 MTaI 2020 PLI & Device Parks → 2023 National Policy

Why the Story of Medical Devices Matters

Doctors and medicines cannot work without devices — a syringe for a vaccine, a thermometer for a fever, an X-ray for a broken bone, a stent for a blocked artery, or a ventilator in intensive care. When these devices are imported, they are costly and can run short in a crisis. The story of India’s medical devices is the story of trying to make safe, affordable devices at home for every hospital and health centre.

Big picture

Indian medical devices in one view

Imported instruments filled colonial hospitals, Indian firms began making syringes, latex goods, and artificial limbs after independence, research institutes created heart valves and blood bags, the first device rules came in 1989, AiMeD was formed in 2002, 100% FDI arrived in 2014, MTaI in 2015, and since 2020 PLI, device parks, and a national policy have pushed domestic manufacturing. Related timelines: research and innovation, Digital India, artificial intelligence.

2002

AiMeD formed by Indian makers

100%

FDI allowed from 2014

~70%

Of devices still imported (estimate)

Medical device parks approved

Split image with a sepia mid-20th-century hospital room where a nurse in a white uniform and cap boils reusable glass syringes in a steel pan on a small stove beside trays of glass syringes and needles and a metal instrument cabinet on the left, and a bright modern clean room where workers in white coveralls, hairnets, masks, and blue gloves inspect plastic disposable syringes on an automated assembly line on the right — From boiling reusable glass syringes to automated lines making disposable ones (artistic illustration).

Medical Devices in India Then vs Now at a Glance

Feature	Around 1947	Now
Where devices came from	Almost all imported	Many made in India, but most high-end devices still imported
Syringes	Reusable glass, boiled between uses	Single-use plastic syringes made in India in billions
Imaging	A few imported X-ray machines	X-ray, ultrasound, CT, and MRI across the country
Implants	Very rare	Stents, heart valves, lenses, and joints, many made in India
Regulation	No device-specific rules	Risk-based Medical Devices Rules 2017
Industry voice	None	AiMeD, MTaI, and chamber forums
Foreign investment	Restricted later under licence rules	100% FDI through the automatic route
Prices of key devices	Unaffordable for most	Price caps on stents and knee implants
Manufacturing hubs	None	AMTZ and four medical device parks planned
Innovation	Almost none	Start-ups, biodesign programmes, and low-cost devices

📦 ImportsBefore 1947

Imported Instruments & Early X-rays

Colonial hospitals and medical colleges depended on instruments, microscopes, and machines shipped from Britain and Europe. X-rays reached India within a few years of their discovery, but equipment was scarce and costly, and most people never saw a modern device outside a big city hospital.

Sepia early 1900s hospital store room where Indian clerks in white turbans and kurtas unpack wooden crates filled with straw and imported steel surgical instruments such as forceps and scissors, a crate of brass microscopes sits on the table, and a European doctor in a white coat with a stethoscope checks an instrument against a ledger beside shelves of jars — Crates of imported instruments and microscopes are unpacked at a colonial hospital (artistic illustration).

1800s: Surgical instruments, stethoscopes, thermometers, and microscopes for Indian hospitals are imported from Britain and Europe.
1896–1900: Soon after Röntgen’s discovery of X-rays (1895), X-ray demonstrations and the first X-ray apparatus appear in Calcutta and other cities, and Jagadish Chandra Bose experiments with X-rays.
1900–1939: Big city hospitals set up X-ray departments with imported machines, and small workshops in undivided Punjab begin making simple steel surgical instruments.
1939–1947: The Second World War cuts supplies and raises demand for dressings, splints, and instruments, and the Bhore Committee (1946) notes India’s severe shortage of medical equipment.

Technology

Steel instruments: Forceps and scalpels.
Glass syringes: Boiled and reused.
X-ray tubes: Early imaging.

Features

Import dependence: Nearly total.
City hospitals: Where devices were.
Small workshops: Simple instruments.

🛠️ Makers1947 – 1988

First Indian Makers

After independence Indian companies and public-sector units began making basic medical products, national laboratories started designing instruments, and Indian doctors and craftsmen created low-cost devices suited to Indian lives. Advanced equipment, however, still came from abroad.

Warm 1970s workshop where an Indian craftsman in a white kurta shapes a light-coloured artificial foot on a wooden workbench covered with hand tools, while another craftsman fits a metal artificial leg with a foot to a smiling young man seated on a wooden bench, with a row of artificial feet on a shelf and a sunny courtyard through the doorway — Craftsmen shape and fit a low-cost artificial foot and leg (artistic illustration).

1957–1959: Hindustan Syringes and Medical Devices is founded in Faridabad (1957), and the Central Scientific Instruments Organisation opens in Chandigarh (1959), later developing medical instruments.
1960s: IDPL sets up a surgical instruments plant in Madras, and Hindustan Latex (now HLL Lifecare) is set up in Thiruvananthapuram in 1966.
1969–1976: Dr. P. K. Sethi and craftsman Ram Chandra Sharma develop the low-cost Jaipur Foot (1969), BMVSS is formed to fit it free (1975), and the Sree Chitra Tirunal Institute begins biomedical technology work (1976).
1977–1988: Indian firms start making diagnostic kits, ECG machines, and patient monitors, and Sree Chitra’s blood bag technology is transferred to industry in the late 1980s.

Technology

Rubber and wood: Jaipur Foot.
Latex products: Gloves and more.
Electronics: Early ECG machines.

Features

Public sector: HLL and IDPL.
Frugal design: Suited to Indian lives.
High-end imports: Still needed.

❤️ Valves & Rules1989 – 2001

Heart Valves, Liberalisation & the First Device Rules

India’s first device rules covered simple products such as syringes and needles, which were treated as “drugs” under the Drugs and Cosmetics Act. Indian scientists produced a home-grown heart valve, low-cost eye lenses transformed cataract surgery, and liberalisation in 1991 brought foreign joint ventures and more imports of advanced equipment.

Late 1980s biomedical laboratory where a young Indian woman engineer in a white coat and safety glasses examines a small metal heart valve with tweezers under a magnifying lamp beside an oscilloscope and a beige computer, while a male engineer in a white coat watches a glass flow-test rig with tubes of red fluid — Engineers inspect and test a mechanical heart valve (artistic illustration).

1989: Disposable syringes, needles, and perfusion sets are notified as “drugs”, the first medical devices regulated in India.
1990: The TTK-Chitra tilting disc heart valve, developed at Sree Chitra Tirunal Institute, is launched commercially at a fraction of the cost of imported valves.
1991–1992: Economic reforms open the door to joint ventures in medical equipment, and Aurolab in Madurai begins making low-cost intraocular lenses for cataract surgery (1992).
1990s: Indian firms expand into disposables, diagnostics, and early coronary stents, while CT scanners, MRI machines, and most implants are still imported.

Technology

Heart valves: Tilting disc design.
Intraocular lenses: For cataract surgery.
Disposables: Single-use syringes.

Features

First rules: Devices as “drugs”.
Indian innovation: Valves and lenses.
Open economy: Joint ventures.

🤝 AiMeD2002 – 2013

AiMeD & Notified Devices

Indian manufacturers came together to speak with one voice, the government extended regulation to high-risk implants, and new programmes began training engineers and doctors to invent devices for Indian needs. Domestic factories grew in disposables and consumables, but imports still dominated high-technology equipment.

Indian medical device factory with a long row of injection moulding machines on the left and workers in light blue uniforms, hairnets, masks, and gloves packing infusion sets and tubing into clear sterile pouches along a steel table, with cartons stacked on pallets — Workers pack infusion sets beside injection moulding machines (artistic illustration).

2002: Indian medical device manufacturers form AiMeD, the Association of Indian Medical Device Industry, to press for policies that support domestic manufacturing.
2005–2006: Stents, heart valves, intraocular lenses, catheters, orthopaedic implants, bone cements, and IV cannulae are notified as “drugs” and regulated by CDSCO.
Mid-2000s: BARC develops Bhabhatron, an Indian cobalt-60 cancer therapy machine, offering a cheaper alternative to imported units.
2008–2012: The Stanford-India Biodesign programme begins at AIIMS and IIT Delhi (2008), and BIRAC is set up (2012) to fund biotech and medtech start-ups.

Technology

Injection moulding: Plastic disposables.
Cobalt therapy: Bhabhatron.
Drug-eluting stents: Indian makers enter.

Features

Industry voice: AiMeD.
Implants regulated: From 2006.
Biodesign: Inventing for India.

🏗️ Make in India2014 – 2019

100% FDI, MTaI & Make in India

Medical devices became a focus of the Make in India campaign, foreign companies were allowed to own device factories fully, and the first dedicated medtech zone was built. Price caps made stents and knee implants affordable, and a separate, risk-based set of rules for medical devices finally arrived.

Bright modern clean room where two engineers in full white clean-room suits, masks, and gloves inspect tiny metal mesh stents under microscopes, trays of polished metal implant parts sit on a stainless steel bench, and a laser cutting machine glows behind a glass wall — Engineers inspect stents and implant parts in a clean room (artistic illustration).

2014: Make in India is launched (September) with medical devices as a focus sector, and in December the government allows 100% FDI in medical device manufacturing through the automatic route.
2015–2016: Research-based medtech companies form MTaI, the Medical Technology Association of India (2015), and Andhra Pradesh launches AMTZ, a dedicated medtech zone in Visakhapatnam (2016).
2017: NPPA caps coronary stent prices (February) and knee implant prices (August), cutting many stent prices by around 70–85%.
2018–2019: The Medical Devices Rules 2017 come into force on 1 January 2018 with Classes A to D, and Ayushman Bharat PM-JAY (2018) raises demand for affordable devices.

Technology

Laser cutting: Precision stents.
Orthopaedic implants: Knees and hips.
Clean rooms: Sterile production.

Features

100% FDI: Automatic route.
Price caps: Stents and knees.
Risk classes: A to D.

🇮🇳 Atmanirbhar2020 – Future

Atmanirbhar MedTech, PLI & Device Parks

The COVID-19 pandemic showed the danger of depending on imports. Indian companies rapidly began making PPE, test kits, and ventilators, and the government launched incentives, device parks, full regulation of all devices, and a national policy to turn India into a medical device manufacturing hub.

Pandemic-era factory floor where workers in masks, face shields, and gloves assemble compact white ventilators at steel workbenches while test units show breathing waveforms on their screens, and women workers in the background sew and fold blue protective coveralls beside stacks of cartons — Workers assemble ventilators and PPE during the pandemic (artistic illustration).

2020: India goes from making almost no PPE kits to producing them in lakhs a day, launches indigenous RT-PCR test kits, and scales up ventilator production.
2020–2021: All medical devices are brought under regulation from April 2020, and PLI schemes and support for four medical device parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh are approved.
2022–2023: Licensing becomes compulsory for Class A and B devices (October 2022) and Class C and D devices (October 2023), and the National Medical Devices Policy is approved (April 2023).
2024–Future: New schemes support components, skills, testing, and exports, with the aim of cutting import dependence and growing the sector to about US$50 billion by 2030.

Technology

Ventilators: Made in India.
RT-PCR kits: Indigenous tests.
AI and imaging: Smart diagnostics.

Features

PLI: Incentives to manufacture.
Device parks: Shared facilities.
National policy: 2023.

Key Institutions, Makers, and Industry Bodies

Name	Year	Role
Hindustan Syringes and Medical Devices	1957	Early Indian syringe maker, Faridabad
Central Scientific Instruments Organisation	1959	CSIR lab developing scientific and medical instruments
HLL Lifecare (Hindustan Latex)	1966	Public-sector maker of latex and health products
BMVSS (Jaipur Foot)	1975	Free artificial limbs for people in need
Sree Chitra Tirunal Institute	1976	Heart valve, blood bag, and other device technologies
Aurolab	1992	Low-cost intraocular lenses and eye-care products
NPPA	1997	Price regulator for medicines and notified devices
AiMeD	2002	Association of Indian Medical Device Industry
Stanford-India Biodesign	2008	Training innovators to invent devices
BIRAC	2012	Funding for biotech and medtech start-ups
MTaI	2015	Medical Technology Association of India
AMTZ	2016	Dedicated medtech manufacturing zone, Visakhapatnam
CDSCO	—	National regulator that licenses medical devices

Rules and Policies for Medical Devices

Milestone	Year	What it did
Drugs and Cosmetics Act	1940	Law later used to regulate devices as “drugs”
First device notification	1989	Syringes, needles, and perfusion sets regulated
Implants notification	2005	Stents, valves, lenses, catheters, and implants regulated
Make in India	2014	Medical devices named a focus sector
100% FDI (automatic route)	2014	Full foreign ownership of device factories allowed
Stent and knee implant price caps	2017	Large cuts in patient costs
Medical Devices Rules	2017 (in force 2018)	Separate risk-based regulation, Classes A–D
All devices notified	2020	Every medical device brought under regulation in phases
PLI and medical device parks	2020	Incentives and shared facilities for manufacturing
Licensing of Class A–D devices	2022–2023	Compulsory licences for all risk classes
National Medical Devices Policy	2023	Roadmap for manufacturing, research, and exports

Everyday Medical Devices Then and Now

Black-and-white 1940s hospital X-ray room where an Indian radiographer in a white coat positions a man in a white hospital gown in front of an upright film stand beneath a large metal X-ray tube on an overhead arm, a nurse in a white sari holds a film cassette, and a bulky control cabinet with dials stands on the left — A radiographer prepares a patient for a chest X-ray on an imported machine (artistic illustration).

Device	Then	Now
Syringe	Reusable glass, boiled	Single-use and auto-disable syringes
Thermometer	Imported mercury glass	Digital and infrared thermometers
Blood pressure	Mercury sphygmomanometer	Digital home BP monitors
X-ray	Bulky imported machines	Digital and portable X-ray units
Heart tracing	Few imported ECG machines	Indian ECG machines and wearable monitors
Scans	None	Ultrasound, CT, and MRI, mostly imported
Heart implants	None	Indian-made stents and heart valves
Eye surgery	Thick glasses after cataract	Low-cost Indian intraocular lenses
Artificial limbs	Heavy, costly, imported	Jaipur Foot and modern prosthetics
Diagnostic tests	Lab tests in big cities	Rapid kits, RT-PCR kits, and glucometers

How India Groups Medical Devices by Risk

Rural health centre room where a health worker in a blue sari holds a handheld ultrasound probe connected to a tablet showing a scan beside a pregnant woman lying on a green examination bed, while a young woman doctor in a white coat with a stethoscope clips a pulse oximeter to the patient’s finger next to a digital blood pressure monitor, with green fields through the window — Portable ultrasound, a pulse oximeter, and a digital BP monitor at a rural health centre (artistic illustration).

Class	Risk	Examples	Who licenses manufacture
Class A	Low	Thermometers, tongue depressors, bandages	State licensing authority
Class B	Low to moderate	Needles, suction equipment, BP monitors	State licensing authority
Class C	Moderate to high	Ventilators, bone implants, dialysis equipment	Central (CDSCO)
Class D	High	Heart valves, coronary stents, implantable pacemakers	Central (CDSCO)

Medical Devices in India Timeline Summary

Year / Era	Milestone
1800s	Instruments imported from Britain and Europe
Late 1890s	First X-rays in India
1946	Bhore Committee notes equipment shortages
1957	Hindustan Syringes founded
1959	CSIO, Chandigarh
1966	Hindustan Latex (HLL)
1969	Jaipur Foot developed
1976	Sree Chitra biomedical technology work begins
1989	First devices regulated as “drugs”
1990	TTK-Chitra heart valve launched
1992	Aurolab intraocular lenses
2002	AiMeD formed
2005	Stents, valves, and implants notified
2008	Stanford-India Biodesign
2014	Make in India; 100% FDI allowed
2015	MTaI formed
2016	AMTZ launched in Visakhapatnam
2017	Stent and knee price caps; Medical Devices Rules
2020	COVID-19 PPE and ventilators; PLI and device parks
2022–2023	Licensing for all device classes
2023	National Medical Devices Policy
Future	Fewer imports and a US$50 billion sector goal

Timeline understanding Science & engineering Make in India Civic awareness

Make a timeline poster: 1969 Jaipur Foot, 1989 first device rules, 1990 Chitra heart valve, 2002 AiMeD, 2014 100% FDI, 2015 MTaI, and 2023 National Medical Devices Policy.
List ten medical devices found in your home or school first-aid kit and group them into risk Classes A to D.
Read about the Jaipur Foot and explain why it suits the way many Indians sit, squat, and walk.
Visit a clinic or pharmacy (with an adult) and find out which devices are made in India and which are imported.
Explain in your own words what “100% FDI through the automatic route” means.
Compare the roles of AiMeD and MTaI and discuss why they sometimes hold different views.
Design a simple, low-cost device to solve a health problem in your village or town, and draw it with labels.
Research how Indian companies made PPE kits and ventilators during the COVID-19 pandemic.
Find out how the 2017 stent price cap changed the cost of heart treatment for patients.
Debate: “India should make all its medical devices at home, even if some cost more at first.”

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India’s medical device story is linked to research and innovation, Digital India, artificial intelligence, and higher education in science and engineering. Explore these connected timelines next.

Research in India timeline Digital India timeline Artificial intelligence timeline Higher education timeline More India timelines All timelines

Moments Through Visual Stories

Click any panel to expand and explore the visual mood.

Indian medical devices in pictures — imported instruments, an early X-ray room, a low-cost artificial limb, a heart valve lab, a disposables factory, a stent clean room, pandemic ventilators, rural diagnostics, and then versus now.

Imported Instruments

Colonial hospitals

Early X-ray

Imported machines

Artificial Limbs

Frugal design

Heart Valve

Made in India, 1990

Disposables

Factory scale

Stents & Implants

Clean-room precision

Ventilators

COVID-19, 2020

Rural Diagnostics

Portable devices

Then vs Now

Glass to disposable

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Disclaimer: This content is AI-generated for educational purposes and may contain errors or outdated details. For correct and authoritative information, please refer to official and reliable sources such as government publications, manufacturers, museums, and academic references.

Medical Devices Timeline of India: Imported Instruments → First Indian Makers → Heart Valves & First Rules → AiMeD → 100% FDI & Make in India → Atmanirbhar MedTech

Why the Story of Medical Devices Matters

Indian medical devices in one view

Medical Devices in India Then vs Now at a Glance

Imported Instruments & Early X-rays

Technology

Features

First Indian Makers

Technology

Features

Heart Valves, Liberalisation & the First Device Rules

Technology

Features

AiMeD & Notified Devices

Technology

Features

100% FDI, MTaI & Make in India

Technology

Features

Atmanirbhar MedTech, PLI & Device Parks

Technology

Features

Key Institutions, Makers, and Industry Bodies

Rules and Policies for Medical Devices

Everyday Medical Devices Then and Now

How India Groups Medical Devices by Risk

Medical Devices in India Timeline Summary

Test Your Knowledge

Students Tasks

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Moments Through Visual Stories

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