Snapshot

Fostering innovation for improved health

The medical device 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 device 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.

The export of medical devices has grown from $ 0.78 bn in FY 2012-13 to $ 0.68 bn in FY 2016-17. Diagnostic Imaging, Consumables, and other medical devices form 86% of total export trade for Indian medical device industry in FY 2016-17.

The USA is the largest export destination, accounting for 15% of the export trade. Singapore, Germany, and China are the other leading export destinations accounting for 7%, 6.7%, and 6.4% respectively. European Union constitutes 27.1% of the total export trade.

Furthermore, the USA, Germany, China, Japan, and Singapore constitute the five largest exporters of high technology medical equipment to India.

 

India’s Medical device industry is poised for significant growth in the next five years:

  • The market size is expected to reach $ 50 bn by 2025 
  • Orthopedics/ Prosthetics & 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
  • 74%

    Pvt. sector's share in hospitals

  • 15%

    Growth rate (2009-2016)

  • 800

    No. of private players in India

  • 250+

    No. of health-tech startups in India

A

India among the top-20 markets for medical devices in the world

B

Market size expected to reach $ 50 bn by 2025

C

Global medical device industry growing at 4.1% CAGR, Indian industry is at 15.8% CAGR 

Industry Scenario

The Medical devices industry in India represents ~2% of the global medical device industry

The industry has the potential to grow at 28% p.a. to reach $ 50 bn by 2025.

Medical Devices are segregated into six major segments, out 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 device manufacturers in India, with an average investment of $ 2.3–2.7 mn and an average turnover of $ 6.2–6.9 mn. 65% of manufacturers are mostly domestic players operating in the consumables segment catering to local consumption with limited exports.
 

Key market shares out of the total medical devices industry (2016)

  • Diagnostic imaging - 36% 
  • Consumables – 19%
  • Patient aids - 9%
  • Orthopaedic & Prosthetic - 8%
  • Dental product – 4%

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.

  • Industrial Parks

    4 medical device parks in India are under-development

  • Government commitment 

    New Medical Device Rules & Regulatory processes, 100% FDI allowed, measures to correct unfavourable duty structure

  • Open

    Classification of medical devices

    Classification of medical devices and in vitro diagnostic me…

  • Open

    Medical Device Rules 2017

    Rules laid down to distinguish medical devices from pharmace…

Major Investors

Data on Map

FAQ

Frequently
Asked Questions

  • How much FDI is permitted under medical devices sector?

    100% FDI is permitted under medical devices sector through automatic route.

  • 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.

  • 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.

  • 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 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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