EU approvals, easier sterilisation rules to speed device access
NEW DELHI: Patients in India could get faster access to some newer medical devices already approved in the European Union, with the government expanding its list of trusted foreign regulatory jurisdictions while also easing licensing requirements for manufacturers outsourcing sterilisation.
The Health Ministry has amended the Medical Devices Rules, 2017 to include the European Union among jurisdictions recognised for waiver of clinical investigation requirements for eligible medical devices that do not have a predicate device in India. The list earlier included the US, UK , Australia , Canada and Japan.
The Health Ministry has amended the Medical Devices Rules, 2017 to include the European Union among jurisdictions recognised for waiver of clinical investigation requirements for eligible medical devices that do not have a predicate device in India. The list earlier included the US, UK , Australia , Canada and Japan.
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