India Releases Final Guidance on Device Safety and Performance
India’s Drugs Controller General adopted essential principles for safety and performance of medical devices marketed in India.
The final guidance sits alongside India’s new Medical Device Rules, which went into effect on Jan. 1.
The final guidance closely mirrors a draft issued in July 2017 but it provides more detail and breaks down categories of devices and in vitro diagnostics more specifically.
In one change from the draft document, the final guidance omits a portion of the preface that said it “does not dictate how a manufacturer should prove that their medical devices have met the essential principles.”