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About the author: Matthew Fenech is medical safety lead at Ada Health, a global digital health company making personalised health accessible for all. His main interest is developing frameworks that ensure health tech tools are safe, effective, and acceptable to patients and healthcare providers alike.
Through COVID-19 many digital health companies felt duty-bound to do something, and to do it fast, given how rapidly the pandemic was accelerating. Companies knew they could make a real difference, but only if solutions were deployed rapidly: the virus would not wait.
This need for speed was true across many areas of healthcare - just look at the emergency approval - which was later revoked - of hydroxychloroquine as a treatment for COVID-19.
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.