Snapshot

Fostering innovation for improved health

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

The current market size of the medical devices industry in India is estimated to be $11 bn.

Medical device sector is projected to register a CAGR of 14.8% and is expected to reach $11.86 bn in 2021-22

The sector is likely to grow to $ 65 bn industry by 2024

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

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

  • Since April 2000, $2.1 bn in FDI
    • Of this, $600 mn was received in the last 5 years
    • Singapore, United States, Europe, and Japan are key investors
  • Equipment & Instruments, Consumables and Implants have attracted most FDI
  • For further details, please refer FDI Policy

Imports: $5.6 bn, Exports: $2.51 bn (2019-20) India’s expected export of medical devices will reach ~ $10 bn by 2025. Overall import dependency of 75 – 80% in India.

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:

  • Recognized Medical Devices as a sunrise sector under Make in India campaign, 2014
  • The Medical Devices Rule of 2017
    • Adopted risk-based classification based on GHT guidelines: Classes A, B, C, D
    • Perpetual licences for manufacturers
  • The Medical Devices Amendment Rules of 2020 bring all medical devices in India under regulation as drugs
  • A Productions Linked Incentives Scheme for Medical Devices, 2020
    • Incentive @ 5% of incremental sales over the base year 2019-20 will be provided on the segments of medical devices identified
      • Cancer care/Radiotherapy medical devices
      • Radiology & Imaging medical devices (both ionizing & non-ionizing radiation products) and Nuclear Imaging Devices
      • Anaesthetics & Cardio-Respiratory medical devices including Catheters of Cardiorespiratory Category & Renal Care Medical Devices
      • AII Implants including implantable electronic devices like Cochlear Implants and Pacemakers.
      • Will lead to expected incremental production of INR 68,437 Crore over a period of 5 years  
  • Funding for Medical Devices Parks in the country, 2020
    • Medical Device Parks with financial implications of INR 400 crores
    • A maximum grant-in-aid of Rs.100 crore per park will be provided to the States
    • Expected to reduce the manufacturing cost of medical devices in the country
    • The Schemes (Parks & PLI) will lead to a generation of additional employment of 33,750 jobs over a period of 5 years
  • %

    Pvt. sector's share in hospitals

  • %

    Growth rate (2009-2016)

  • Number of pvt. players in India

  • +

    Number of health-tech startups in India

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

Market size expected to reach $ 50 bn by 2025

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

Medical devices Information Kit
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Industry Scenario

Medical Devices industry has the potential to grow at 28% per annum and reach $50 Bn by 2025

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 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. In 2019, Andhra Pradesh, Telangana, Tamil Nadu, and Kerala have got in-principle approval from Government of India for new medical devices parks.

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

Industrial Land Bank Portal

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

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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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