Archive · 24 Aug 2026
India Eases Outsourced Sterilisation Rules for Medical Devices
The Indian government changed some rules for medical device companies.
Companies can now send their products to an approved outside facility for sterilisation without getting another licence.
The outside facility must already have a valid medical-device licence.
The device label must show that facility’s licence number so people can trace where sterilisation happened.
Companies have six months to start following this labelling rule.
The government also recognised the European Union as a stringent medical-device regulatory jurisdiction.
This may allow some devices approved there to avoid a separate clinical investigation in India.
The changes are intended to reduce paperwork and make compliance easier while maintaining safety standards.
Medical device manufacturers no longer need a separate loan licence to outsource sterilisation.
The sterilisation facility must already hold a valid licence under the Medical Devices Rules, 2017.
Manufacturers must include the sterilisation facility’s licence number on device labels.
A six-month transition period has been provided for the new labelling requirement.
The European Union was added to jurisdictions whose approvals may support clinical-investigation waivers in India.
- Who
- The Union Ministry of Health and Family Welfare, medical device manufacturers, and licensed sterilisation facilities.
- What
- The government removed the separate loan-licence requirement for outsourced sterilisation and added the European Union to recognised stringent regulatory jurisdictions.
- When
- The changes were reported on August 24, 2026; manufacturers have a six-month transition period for the labelling requirement.
- Where
- India, under the Medical Devices Rules, 2017.
- Why
- To simplify compliance, reduce paperwork and costs, improve predictability, and support ease of doing business while maintaining medical-device quality and safety standards.
- Previous requirement
- Manufacturers needed a separate loan licence when using an outside sterilisation facility.
- New requirement
- No separate loan licence is needed if the sterilisation facility has a valid licence under the Medical Devices Rules, 2017.
- Labelling
- The sterilisation facility’s licence number must appear on the medical-device label.
- Transition period
- Manufacturers have six months to comply with the new labelling requirement.
- Newly recognised jurisdiction
- The European Union was added to the list of stringent regulatory jurisdictions.
- Existing recognised jurisdictions
- The list already included the United States, United Kingdom, Australia, Canada, and Japan.
- Potential clinical-investigation waiver
- Certain devices approved by stringent regulators in these jurisdictions may qualify for a waiver from clinical investigation in India, subject to applicable conditions.