Manufacturers can outsource sterilisation without obtaining a separate loan licence, provided the facility carrying out the sterilisation has a valid licence
Medical device manufacturers will no longer need a separate licence when they outsource the sterilisation of their products to a facility that already has a valid licence under the Medical Devices Rules, 2017, said the changes notified by the Union Ministry of Health and Family Welfare.Earlier, manufacturers had to obtain a separate loan licence even when they sent their products to an outside sterilisation facility that was already licensed under the rules. This created an additional regulatory requirement for companies using third-party sterilisation services.The government has now removed this requirement. Manufacturers can outsource sterilisation without obtaining a separate loan licence, provided the facility carrying out the sterilisation has a valid licence under the Medical Devices Rules, 2017.Simplifying ComplianceHowever, the licence number of the sterilisation facility will have to be mentioned on the label of the medical device. This will ensure that the facility responsible for sterilisation can be identified and the process remains traceable.Officials at the Union Ministry of Health and Family Welfare said the change is aimed at simplifying compliance, reducing paperwork and supporting ease of doing business for the medical device industry.The ministry has also provided manufacturers a six-month transition period to comply with the new labelling requirement related to outsourced sterilisation.Clinical InvestigationsMeanwhile, the government has also added the European Union to the list of stringent regulatory jurisdictions recognised under the Medical Devices Rules. The list already includes the US, UK, Australia, Canada and Japan.This change will allow certain medical devices approved by stringent regulators in these jurisdictions to get a waiver from the requirement of conducting a clinical investigation in India, subject to the applicable conditions.The government said the reforms were intended to simplify the regulatory process, reduce compliance costs and improve predictability for the medical device industry while maintaining standards for the quality, safety and performance of medical devices.Published on August 24, 2026
