Jan 24, 2022

India’s Ministry of Health and Family Welfare has finalized plans to indefinitely postpone unique device identification (UDI) requirements for medical devices.

According to a notification in The Gazette of India, Rule 46 of India’s Medical Devices Rules 2017 have been amended to enable the government to determine how and when to implement UDI requirements. Previously, UDI rules were set to take effect January 1, 2022.

The final amendment to Rule 46 and delayed implementation of UDI requirements was first proposed by the Ministry in mid-December 2021.

Emergo by UL consultants in New Delhi and Secunderabad will provide updates once Indian regulators announce a new UDI compliance deadline for medical device registrants.

Additional Indian medical device regulatory resources:

Author

  • Stewart Eisenhart

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