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.
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.
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: $6.2 bn, Exports: $2.1 bn (2018-19) 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.
- Incentive @ 5% of incremental sales over the base year 2019-20 will be provided on the segments of medical devices identified
- Funding for Medical Devices Parks in the country, 2020
- Financing Common Infrastructure Facilities in 4 Medical Device Parks with financial implications of Rs. 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
