India amends Medical Devices Rules to ease outsourced sterilisation licensing and add EU waiver

The Ministry of Health amended the Medical Devices Rules, 2017 to remove the requirement for a separate loan licence when a manufacturer outsources sterilisation to another facility that already holds a valid licence under the rules. It also amended Rule 63 to add the European Union to the list of recognised stringent regulatory jurisdictions for waivers of clinical investigation requirements for certain medical devices without predicate devices, and provided a six-month transition period for a new labelling requirement.