Snapshot

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.

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 – December 2022
  • For further details, please refer FDI Policy

The export of medical devices sector has been growing at a CAGR of 9.37% over the last 5 years. 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:

  • Production Linked Incentives: Government has launched Production Linked Incentive Schemes for medical devices with financial incentives worth $400mn to boost domestic production
  • Development of Medical Devices Parks: New Medical Devices Parks upcoming in Himachal Pradesh, Uttar Pradesh, Madhya Pradesh, & Tamil Nadu to create a robust ecosystem for medical device manufacturing
  • Policy Support: Release of National Medical Devices Policy to enable strong collaborations for boosting medical devices ecosystem & National R&D Policy to foster interdisciplinary collaborations to develop translational skills & start-up ecosystem
  • %

    Market Growth Rate (expected)

  • +

    Types of Medical Devices in India

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    MedTech Startups

Recognized as a Sunrise Sector of India under Make in India Campaign of 2014

Market size expected to reach $ 50 bn by 2030

India is the fastest growing medical devices market amongst the emerging markets.

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

There are 750-800 domestic medical devices manufacturers in India, accounting for 65% of the market. The start-up ecosystem in India’s medical devices sector is diverse and vibrant, with 250+ organisations engaged in innovations for addressing important health issues.

Indian medical devices sector’s contribution has become even more prominent since India supported the domestic and global battle against COVID-19 pandemic through the production of medical devices & diagnostic kits, such as ventilators, Rapid Antigen Test kits, RT-PCR kits, IR thermometers, PPE kits & N-95 masks.

The manufacturing footprint in India is developing in its scale and geography: Dedicated Medical devices manufacturing “clusters” and Parks are being developed 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. 4 Medical Devices Parks are coming up in Himachal Pradesh, Tamil Nadu, Madhya Pradesh, and Uttar Pradesh to provide easy access to standard testing and infrastructure facilities for medical devices manufacturing.

GROWTH DRIVERS

  • Growing Population

    ​India has become the world’s most populous nation, making the demand for medical devices greater than ever before.

  • 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

    Expected to grow to $13 Bn by 2026, the medical tourism sector is set to accelerate demand for high-end technological devices, medical equipment, and appliances

  • Infrastructural Development

    4 Medical Devices Parks are coming up in Himachal Pradesh, Tamil Nadu, Madhya Pradesh, and Uttar Pradesh

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Production Linked Incentive (PLI) Scheme

The government has launched the Production Linked Incentive (PLI) Scheme to boost domestic manufacturing in the medical devices sector. Under the PLI scheme for Medical Devices, till now, a total of 26 projects have been approved, with a committed investment of INR 1206 Cr (~$147 mn) to enable growth and innovation in the MedTech industry and make India as the global hub for manufacturing and innovation in the coming years.

  • INR 3420 Cr

    Schemes Outlay

Ministry

Products

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Industrial Land Bank Portal

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

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Major Investors

Data On Map

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FAQs

Frequently
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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