[CLSTR]
< Back to situations

Monitor this situation.

[SITUATION] · [ACTIVE] · [BUSINESS]

2 clusters · 11 sources · 18 days · First seen · Last updated

India medical device regulatory and infrastructure reforms

Overview

India is implementing regulatory and financial reforms to strengthen its medical device manufacturing sector. The Ministry of Health and Family Welfare amended the Medical Devices Rules, 2017, to streamline compliance and promote the ‘Ease of Doing Business’. These changes include removing the need for separate loan licences when outsourcing sterilisation to licensed facilities, requiring only that the facility’s licence number be included on device labels. The government also recognized the European Union as a stringent regulatory jurisdiction, allowing for clinical investigation waivers for certain devices.

To further support the industry, Commerce and Industry Minister Piyush Goyal announced 100% government funding for advanced testing equipment. The Association of Indian Medical Device Industry (AiMeD) welcomed this move, noting that shared, internationally accredited testing facilities will help domestic manufacturers, particularly startups and MSMEs, become globally competitive in technology and quality while reducing reliance on overseas testing.

Entities

Association of Indian Medical Device Industry · India · Rajiv Nath · Ministry of Health and Family Welfare · European Union

Timeline

  1. 1 day ago

    [BUSINESS] 2 sources
    India to provide 100% government funding for medical device testing

    The Association of Indian Medical Device Industry (AiMeD) welcomed the Indian government's decision to provide 100% funding for advanced medical device testing infrastructure.

  2. 20 days ago

    [BUSINESS] 10 sources
    India amends medical device rules to ease regulatory compliance

    India has amended its Medical Devices Rules to simplify licensing for outsourced sterilisation, standardise testing fees, and grant clinical trial waivers to devices approved in the European Union.

Sources

bhaskarlive.in · bilkulonline.com · businessnewsthisweek.com · electronicsb2b.com · expresshealthcare.in · ibtimes.co.in · idronline.org · medgatetoday.com · newindianexpress.com · newsable.asianetnews.com · socialnews.xyz