Tuesday, January 12, 2021
This year has been perhaps the most significant year for medical device companies from a regulation perspective since the Medical Device Rules, 2017 (explained below) came into force on January 01, 2018. The Government has amended medical device regulation to significantly expand the reach of medical device regulation. There is also some discussion on enacting a new legislation altogether specifically for medical devices (medical devices are currently regulated as drugs). The sector has also been largely unaffected by the COVID-19 pandemic and the regulator provided for relaxations in regulatory compliances as required.
In this wrap, we have covered some of the significant developments in the medical device space this year and what we hope to see ahead in 2021.