Clinical trials form a critical phase in the development and approval of medical devices. They provide the necessary evidence to demonstrate the safety and efficacy of a device before it can be marketed. The United States Food and Drug Administration (US FDA) sets stringent requirements for conducting clinical trials to ensure that the data collected are reliable and that patient rights are protected.

The Union Ministry of Health (MoH), India has released a draft Gazette Notification – Medical Devices (Amendment) Rules, 2021. These rules are an amendment to the original “Medical Devices Rules, 2017”, published on January 31, 2017, in the Official Gazette under the Notification No. G.S.R.78(E). The amendment rules read –

“In the Medical Devices Rules, 2017, in rule 7, in sub-rule (2), after the words, letters and bracket “the