Union Ministry Eases Compliance for Medical Device Manufacturers on Outsourced Sterilisation

Medical device manufacturers in India will no longer be required to obtain a separate loan licence when outsourcing product sterilisation, according to recent notifications issued by the Union Ministry of Health and Family Welfare.

Previously, manufacturers were mandated to secure a separate loan licence even when utilizing third-party sterilisation facilities that were already authorized under the Medical Devices Rules, 2017. Industry stakeholders noted that this created an additional layer of regulatory compliance and paperwork for companies relying on external services.

Under the revised framework, manufacturers can outsource sterilisation to any facility that maintains a valid licence under the Medical Devices Rules, 2017, without the need for an additional loan licence. However, to ensure traceability and accountability, the licence number of the third-party sterilisation facility must be clearly printed on the medical device's label.

Ministry officials stated that the regulatory modification is designed to simplify compliance, minimize paperwork, and foster ease of doing business within the domestic medical device sector. To help companies adapt to the new packaging standards, the government has granted a six-month transition period for compliance with the updated labelling mandate.

In a related regulatory update, the Union Ministry has expanded its list of recognized stringent regulatory jurisdictions under the Medical Devices Rules to include the European Union. The list previously encompassed the United States, the United Kingdom, Australia, Canada, and Japan.

This inclusion permits certain medical devices that have already received approval from stringent regulators within these jurisdictions to qualify for a waiver from mandatory clinical investigations in India, subject to prevailing conditions. According to the government, these coordinated reforms are intended to lower compliance costs, enhance regulatory predictability, and streamline procedures while upholding safety, quality, and performance benchmarks for medical devices.

"Removing the requirement for a separate loan licence for outsourced sterilisation is a practical step that directly addresses operational bottlenecks for medical device manufacturers. By cutting down redundant paperwork and introducing a clear transition period for labelling, the government is actively supporting ease of doing business. Furthermore, the inclusion of the European Union in the list of recognized stringent regulatory jurisdictions will help reduce compliance costs and streamline clinical requirements for market participants." — Dr. Shishir Gupta, Founder & CEO, StartupLanes