Medical device rules eased for outsourced sterilisation; EU added to stringent regulatory jurisdictions
The Indian Health Ministry has proposed amendments to medical device regulations to simplify the licensing process for outsourced sterilization. Additionally, the EU has been added to the list of jurisdictions whose regulatory approvals allow for the waiver of clinical investigations in India.
Why it matters
These changes aim to reduce administrative burdens and compliance costs for manufacturers, potentially accelerating market access for medical devices.
The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, to promote ease of doing business. The amendments seek to simplify regulatory requirements, standardise testing fees and facilitate faster market access for eligible medical devices.
The Centre has eased regulatory requirements for medical device manufacturers by removing the need for a separate licence for outsourced sterilisation and expanding the list of countries and regulatory jurisdictions whose approvals can facilitate waiver of clinical investigation requirements in India, a release issued by the Ministry said on Monday (August 24, 2026).
Under the proposed amendment to Rule 44, manufacturers that outsource sterilisation of their medical devices to a facility holding a valid licence under the Medical Devices Rules, 2017, will no longer have to obtain a separate loan licence for the sterilisation activity.
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