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India's Medical Devices & MedTech Sector

India's medical-device industry is worth roughly $15-16 billion a year, the fourth-largest med-tech market in Asia, and the government is trying to cut a long dependence on imported scanners, implants and intensive-care kit through the PLI scheme, Medical Device Parks and the National Medical Devices Policy, 2023. Two regulatory moves followed the August 2026 device show: the Medical Devices Rules, 2017 were amended (Rules 44 and 63) to drop separate loan licences for outsourced sterilisation and to add the European Union to the list of jurisdictions whose approvals waive clinical investigation, while a 22 August notification barred every chlorpheniramine-phenylephrine fixed-dose combination for children under four.

Last updated 27 August 20267 min read
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Added the Medical Devices Rules amendments: outsourced sterilisation no longer needs a separate loan licence (Rule 44) and EU approval now waives clinical investigation for devices without a predicate (Rule 63); plus the Section 26A order keeping chlorpheniramine-phenylephrine combinations away from children under four.

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India's Medical Devices & MedTech Sector — Economy & Banking current affairs | CA·Wiki