Medical Devices

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 nearly $11 bn.

The Medical device sector has been growing steadily at a CAGR of 15% over the last 3 years

India’s medical devices industry is poised for significant growth in the coming years with the market size 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, ~$2.2 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.

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:

• Designated as a sunrise sector under the Make in India campaign, 2014
  • India is among the top 20 markets for medical devices worldwide
• The Medical Devices Rule of 2017
  • The Ministry of Health & Family Welfare in line with global best practices adopted a risk-based classification system for medical devices based on the Global Harmonisation Task Force (GHTF)
  • Increased number of regulated medical devices in India to ensure quality
  • Introduction of post-market surveillance for imported and manufactured devices
  • Manufacturing licenses made perpetual to promote ease of doing business in the sector
  • Increased notified devices, clinical investigations, quality certifications, and post-market surveillance
• Under the Medical Devices Amendment Rules 2020, all medical devices intended for use in human beings or animals are regulated as drugs w.e.f April 1st, 2020
• A Productions Linked Incentives Scheme for Medical Devices, 2020
  • Incentive on 5% on incremental sales over the base year of good manufactured in India covered under target segments
  • Production Linked incentives of up to INR 3,420 Cr (~$456 Mn) will be awarded during the scheme tenure
  • Tenure of the scheme is from FY 2020-21 to FY 2027-28, with Base Year as FY 2019-20
  • The Department of Pharmaceuticals is reinviting applications under the Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices. The last date of receipt of applications is July 28th, 2021. For more details, please visit this link
  • Production Linked Incentive Scheme (PLI 2.0) is inviting applications to enhance India's manufacturing capabilities in the in-vitro diagnostic sector (IVDs). The scheme shall be open for applications till July 31st, 2021. Applications to be made online here  
• 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