Centre eases Medical Devices rules, adds EU to waiver list
The Union Health Minister recently amended the Medical Devices Rules, 2017, dropping the requirement for a separate loan licence when medical devices are outsourced for sterilisation. This change aims to reduce duplication, administrative burden, compliance costs and timelines, especially for manufacturers without in-house sterilisation facilities.
The ministry further added the European Union to the list of recognised stringent regulatory jurisdictions for waiving clinical investigation requirements for medical devices without predicate devices. This move will benefit eligible medical devices already approved in the EU, facilitating quicker patient access to advanced medical technologies in India.
The amendment follows the signing of the India-EU Free Trade Agreement in January, which brings tariff cuts on European medical devices.
Written by urgent.news from ETHealthworld's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
