Health Ministry Proposes Medical Device Rule Changes To Ease Business, Speed Up Market Access
The Union Ministry of Health and Family Welfare proposed regulatory reforms to ease licensing for outsourced sterilisation and expand clinical investigation waivers. These changes aim to simplify compliance, reduce costs, and expedite access to advanced medical technologies. A six-month transition period will allow manufacturers to adapt to new labelling requirements, enhancing operational flexibility and competitiveness in the medical device sector.