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, with extensive service networks, as well as small and medium enterprises (SMEs). The current market size of the medical devices industry in India is estimated to be $11 bn.
Diagnostic imaging, consumables, and other medical devices form 86% of total export trade for Indian medical devices industry in FY 2016-17.
The U.S. is the largest exporter, accounting for 15% of the export trade. Singapore, Germany, and China are the other leading exporters, accounting for 7%, 6.7%, and 6.4% respectively. The European Union constitutes 27.1% of the total export trade.
Furthermore, the U.S., Germany, China, Japan, and Singapore constitute the five largest exporters of high technology medical equipment to India.
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
- Orthopaedic prosthetics and 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
100% FDI is allowed under the automatic route.
For further details, please refer FDI Policy