CONDUCIVE ENVIROMENT FOR FOSTERING INDIA SPECIFIC INNOVATION: NEW MEDICAL DEVICE RULES 2017

  • Pratibha Chauhan
  • Rahul Chauhan

Abstract

The medical technology sector in India valued at approximately $ 10 billion in 2015 at end consumer prices and is growing at 10-12 percent annually. Currently, the Indian medical devices industry represents just over 2 percent of the global medical device market. With such immense potential, some of the challenges that this industry faced with lack of framework. India’s medical device sector was greeted by a breakthrough announcement during union budget speech in 2017. India’s finance minister declared that the government would formulate new norms, ‘harmonized with international rules’, for the medical devices sector. Post which Ministry of Health and Family Welfare released a media statement that it had notified the Medical Device Rules 2017 on Jan 31st, which would be enforceable from January 2018. These new medical device rules would attract more foreign investment and reduce prices of medical devices. This positive policy push for the development of the domestic medical device market will potentially bring more devices under its ambit, the new medical rules will bring in a huge wave of relief to consumers, protecting their right to access high quality and safe products. As the fastest growing healthcare market in the world, the government can further take several measures to create a conducive environment to consolidate the growth of the medical devices sector with regularly advising new guidances. The recent notification on essential principles for safety and performance of medical device, risk based classification with list of medical devices and in-vitro diagnostics, notified bodies auditing the firms demonstrates the favorable environment for manufacturing of medical devices nurturing growth and innovation in the country.

Keywords: Medical devices, Essential Principle, Risk Based Classification, Policy infrastructure, Regulatory regime.

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How to Cite
Chauhan, P., and R. Chauhan. “CONDUCIVE ENVIROMENT FOR FOSTERING INDIA SPECIFIC INNOVATION: NEW MEDICAL DEVICE RULES 2017”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 3, Feb. 2018, pp. 20-26, doi:10.22270/ijdra.v5i3.203.