1 week ago

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.

Key facts

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.

thehindubusinessline.com · 1 week ago