Fostering innovation for improved health

The current market size of the medical devices industry in India is estimated at $11 bn. India is the fastest growing medical devices market amongst the emerging markets

The medical devices industry in India consists of large multinationals as well as small and medium enterprises (SMEs) growing at an unprecedented scale

The medical devices industry is expected to grow at a CAGR of 15% which is 2.5x the global growth rate

The medical devices industry in India is poised for significant growth with the market size expected to reach $50 bn by 2030

100% FDI is allowed under the automatic route for both brownfield and greenfield setups. Strong FDI inflows reflect the confidence of global players in the Indian market

  • $ 2.7 bn FDI inflows in Medical and Surgical Appliances from April 2000 - June 2022
  • Equipment & Instruments, Consumables and Implants have attracted most FDI
  • For further details, please refer FDI Policy

Imports: $8.5 bn, Exports: $2.9 bn (FY 2021-22) India’s expected export of medical devices will reach ~ $10 bn by 2025.

The Government of India has taken several steps to ensure the growth of a vibrant ecosystem of medical devices manufacturing in India over the past 5 years:

  • Medical Devices Rules, (MDR) 2017: The Medical Devices Rules (MDR), 2017 regulates Clinical Investigation, Manufacture, Import, Sale, and Distribution of Medical Devices. The devices are classified into 4 classes, harmonized with international guidelines
  • Production Linked Incentive Schemes: To boost domestic manufacturing, Government has launched Production Linked Incentive Schemes (PLI 1.0 & PLI 2.0) for medical devices for 4 key target segments & in- vitro diagnostics
  • Scheme for Promotion of Medical Devices Parks: Government of India has approved to establish 4 medical devices parks to provide common infrastructure facilities, create a robust ecosystem for medical device manufacturing, and reduce the manufacturing cost significantly
  • Public Procurement Order (PPO): Department of Pharmaceuticals released a Public Procurement Order (PPO) in March 2021 incorporating 19 devices in the revised guidelines, strengthening Make in India
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    Market growth rate (2019-20)

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    Types of Medical Devices in India

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    MedTech Startups

Market size expected to reach $ 50 bn by 2030

India is the 4th largest market for medical devices in Asia, among the top 20 markets for medical devices worldwide

2nd largest PPE Kits manufacturer with production capacity 10 lakh+ PPE coveralls per day

Industry Scenario

The medical devices market in India has the potential to grow ~4x the current market size by FY 2030, backed by growing healthcare needs and government’s commitment to facilitate growth

Medical devices are segregated into five major segments:

  • Consumables & Disposables include needles and syringes, etc
  • Diagnostic Imaging includes MRI, X-Ray, Ultrasounds, etc
  • Dental Products includes dentures, braces, etc
  • Orthopaedics & Prosthetics include knee implants, artificial joints
  • Patient Aids include hearing aids and pacemakers, etc

Around 65% of the manufacturers in India are mostly domestic players operating in the consumables segment and catering to local consumption with limited exports. Large Multinational Corporations lead the high technology end of the Medical Devices market in India with extensive service networks.

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.

The manufacturing is developing in its scale and geography: there are six Medical devices manufacturing “clusters” in the country (Refer to 'Data on Map' section below).

Clusters have “Medical Device Parks” developing around them: states have committed to set-up dedicated industrial parks where efficient domestic manufacturing at lower costs. The State Government of Himachal Pradesh, Tamil Nadu, Madhya Pradesh and Uttar Pradesh have been given “in-principle” approval to develop Medical Devices Parks & create a robust ecosystem for medical device manufacturing in the country.


  • Growing Population

    India’s population is set to touch 1.45 bn by 2028, making it the world’s most populous nation

  • Life Expectancy

    From the current 67.5 years, life expectancy in India is expected to increase to 70 years by 2025

  • Shifting Disease Burden

    Non-Communicable Diseases (NCDs) account for 50% of the disease burden and 60% of all deaths in India

  • Changing Preferences

    Growing health awareness, changing attitude towards preventive healthcare, & increasing onset of lifestyle diseases

  • Growing Middle Class

    ~73 mn households will be moving into the middle-class category in India over the next 10 years, thereby enhancing their purchasing power, including with respect to Medical Devices

  • Increasing disposable income

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

  • Health Insurance

    Approx. 20% of Indians have health insurance cover. This number is expected to increase with rising incomes and growing urbanization

  • Rise in Medical Tourism

    Due to the relatively low cost of medical care in India, it is experiencing a 22-25% growth. It contributes over $2Bn to the healthcare market in India. Increased demand for healthcare and medical devices from rise in medical tourism.

  • Infrastructural Development

    4 medical devices parks in India are in pipeline

  • Policy Support & Incentives

    100% FDI allowed in Greenfield & Brownfield projects, relatively lower barriers to entry compared to other industries, diverse and vibrant start-up ecosystem


Production Linked Incentive (PLI) Scheme

The Indian Government has identified medical devices as a priority sector for the flagship 'Make in India' program and is committed to strengthening the manufacturing ecosystem. The Production Linked Incentive Scheme (PLI) Promoting Domestic Manufacturing of Medical Devices and Production Linked Incentive Scheme for Pharmaceuticals (PLI 2.0) have been introduced to provide an impetus to India’s vision of becoming a global manufacturing hub for medical devices.

  • 18420 Cr

    Schemes Outlay


Industrial Land Bank Portal

GIS - based map displaying available infrastructure for setting up business operations in the state.

Major Investors

Data On Map

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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.

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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.

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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.

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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.

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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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