The medical devices industry in India consists of large multinationals, with extensive service networks, as well as small and medium enterprises (SMEs). The current market size of the medical devices industry in India is estimated to be $ 5.2 bn. As per the Department of Pharmaceuticals, the estimated retail market for medical devices is between $ 9.3 bn – $ 10.8 bn.
Diagnostic imaging, consumables, and other medical devices form 86% of total export trade for Indian medical devices industry in FY 2016-17.
The U.S. is the largest exporter, accounting for 15% of the export trade. Singapore, Germany, and China are the other leading exporters, accounting for 7%, 6.7%, and 6.4% respectively. The European Union constitutes 27.1% of the total export trade.
Furthermore, the U.S., Germany, China, Japan, and Singapore constitute the five largest exporters of high technology medical equipment to India.
India’s medical devices industry is poised for significant growth in the next five years:
100% FDI is allowed under automatic route.
For further details, please refer FDI Policy
Pvt. sector's share in hospitals
Growth rate (2009-2016)
Number of pvt. players in India
Number of health-tech startups in India
India among the top-20 markets for medical devices in the world
Market size expected to reach $ 50 bn by 2025
Indian medical devices industry is growing at a CAGR of 15.8%, vis-à-vis a CAGR of 4.1% for the Global medical devices industry
Medical devices are segregated into six major segments, of which equipment and instruments (surgical and non-surgical) form the largest portion (53%) of the pie in India.
There are 750–800 domestic medical devices manufacturers in India, with an average investment of $ 2.3–2.7 mn and an average turnover of $ 6.2–6.9 mn. Around 65% of the manufacturers are mostly domestic players operating in the consumables segment and catering to local consumption with limited exports.
Key market shares out of the total medical devices industry (2016)
Medical device startup Biosense raises $ 1 mn from Menterra Venture, Artha Venture Challenge
Apax Partners acquires Healthium MedTech for $ 350 mn
Neuberg Diagnostics, an alliance of five leading pathology laboratories from India, South Africa and the UAE, is planning to invest $ 45.9 mn in India, the Middle East and Africa as part of its expansion plans.
Healthcare data and health-IT upgrades to enhance AI functionality for diagnostic and treatment devices
Glucose monitors, exercise trackers, wearables for mental health, boosting home-based healthcare
Assistive robotic surgeries, minimally invasive surgeries, predictive diagnosis, role of artificial intelligence
In 2016, around 115 deals were made in healthtech sector with a total investment of $ 140.2 mn
National Telemedicine Network, SATCOM-based telemedicine nodes, and mobile health clinics
India Pavilion at MEDEX 2019, Yangon, Myanmar…
Setting up Business in India
Medical Devices Sector
The Ministry of Health and Family Welfare on Thursday notified Medical Devices Rules, 2017, which are in conformity with Global Harmonisation Task Force (GHTF) framework. The rules have come into effect from 1 January 2018.
The rules have been drafted with the intention to distinguish medical devices from pharmaceuticals for improved and well-defined regulation. The key highlights of the rules are:
1) Redefining ‘medical devices’, making it more comprehensive and easy to comprehend.
2) Introduction of risk-based classification system for class-wise regulation.
3) Single window clearance (online portal) for applications for import, manufacture, sale or distribution and clinical investigation.
4) Establishment of product standards for medical devices for being conformed.
5) Rationalization of timelines for obtaining licenses required to market medical devices.
6) Consolidation of registration certificate and import license into a single license.
7) New regulatory framework for clinical investigation of medical device.
The requirements are laid down in Part I of Third Schedule of Medical Devices Rules, 2017.
The Central Licensing Authority shall, classify medical devices referred to in Rule 2, based on their intended use and other parameters specified in the First Schedule.
Based on the classification referred to in sub-rule (3), class wise list of medical devices shall be published on the website of the Central Drugs Standard Control Organization (CDSCO): Provided that the Central Licensing Authority may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device. CDSCO has already displayed the list of medical devices with classification, which is dynamic in nature.
The following changes require a fresh registration:
1) Any change with respect to manufacturer (legal/actual) like change in constitution,change in name, change in address, etc.
2) Any change with respect to importer/Indian Agent like change in constitution, change in name, etc.
IVDs are classified under Chapter II, Rule 4, Sub-rule (2) of Medical Device Rules, 2017 on the basis of parameters specified in Part II of the First Schedule, in the following
classes, namely:
i) Low risk - Class A,
ii) Low moderate risk- Class B.
iii) Moderate high risk- Class C.
iv) High risk- Class D.
Reference Rule 4 (3): This rule specifies that Central Licensing Authority shall classify the Medical Devices.
By: Invest India
By: Invest India
By: Invest India
By: Uday Munjal
By: Invest India
By: Invest India
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