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The reforms amend the Medical Devices Rules, 2017 to simplify outsourced sterilization, standardize testing fees and recognize the EU for waiver of clinical investigation requirements.
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CDSCO has issued the Guidance Document on Medical Device Software to align India’s regulatory requirements with globally harmonized practices and streamline approvals.
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The regulator said it had received reports that ART media and related products were being supplied to unregistered facilities, thereby posing risk to patient health and welfare.
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The newly appointed Drug Inspectors are authorized to exercise the powers and perform the duties as specified in Sections 21 and 22 of the Drugs and Cosmetics Act and the Medical Devices Rules.
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