Fostering innovation for improved health

Indian medical device industry is dominated by large multinationals with extensive service networks. With the entry of new global players and the growing presence of existing ones, import of medical devices, equipment and consumables witnessed a CAGR of around 6.8% during 2010-2015 in USD terms. Consequently, in 2015, imports accounted for nearly 72% of the market.

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

  • Market size expected to reach USD 50 bn by 2025
  • The rising per capita income is projected to increase per capita spending on medical devices to USD 3.7 bn by 2020 from USD 2.7 bn in 2015
  • Orthopaedics and 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

Industry Scenario

The industry is forecasted to reach USD 5.6 bn by 2021, growing at a CAGR of 7.6% (2015–2021)

The domestic industry for medical devices in India is highly fragmented with a large number of players from small and medium enterprises (SMEs). Currently, around 800 manufacturers of medical devices operate in the country.

Industry was valued at USD 3.6 bn in 2015, and grew at a CAGR of 3.8% from 2012 to 2015.

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%

Key policies

Medical Device Rules (2017)

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 January 01, 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 to be conformed to
  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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