Fostering innovation for improved health

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 $11 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:

  • The market size is expected to reach $ 50 bn by 2025 
  • Orthopaedic prosthetics and patient aids segments to be the two fastest-growing verticals by 2020 and are projected to grow at a CAGR of 9.6% and 8.8%, respectively
  • Diagnostic imaging, dental products, and consumables are expected to grow at a CAGR of 7.1%, 7.4% & 7.1%, respectively during 2015-20

100% FDI is allowed under the 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


India is the 4th largest market for medical devices in Asia

Industry Scenario

Medical devices industry in India has the potential to grow at 28% p.a. to reach $ 50 bn by 2025

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)

  • Diagnostic imaging - 30% 
  • Other medical devices - 24%
  • Consumables – 16%
  • IV Diagnostics - 10%
  • Patient aids - 9%
  • Orthopaedic prosthetics - 8%
  • Dental products – 3%

Growth Drivers

  • Nascent industry

    Importing more than 90% of sophisticated devices, the domestic industry has a huge scope for R&D capacity

  • Demographics

    Ageing population, life expectancy to cross 70 years by 2022, thereby requiring home-based healthcare devices

  • Increasing disposable income

    8% Indians will earn more than $ 12,000 p.a. by 2026

  • Industrial Parks

    4 medical devices parks in India are under-development

  • Government commitment

    New rules and regulatory processes for the medical devices sector, 100% FDI allowed, measures to correct unfavourable duty structure undertaken

Major Investors

Data On Map

Medical equipment business in India

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Asked Questions

What is the regulatory environment for medical devices in India as per 'New Medical Devices Rules'?

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.

What are the requirements to be a registered Notified body?

The requirements are laid down in Part I of Third Schedule of Medical Devices Rules, 2017.

What is the process for classification verification with CDSCO or notified body prior to submission?

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.

What are the changes that require an applicant to make afresh Registration?

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.

How are IVDs classified in India under Medical Device Rules, 2017? Who will have the responsibility of doing Classification of IVD as per Class A/B/C/D?

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.


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