Gunjan Verma - India

“Once implemented, the new rules will affect all medical devices, including those already registered under an Import License.”

Gunjan Verma
Managing Partner
Asia Actual India

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UDI Requirements in India Temporarily Delayed

Published on: January 17th, 2022

UDI Requirements in India Delayed Indefinitely

On December 31, 2021, the Indian Ministry of Health and Family Welfare and Department of Health and Family Welfare issued the FINAL NOTIFICATION for the amendment of Rule 46 of Medical Device Rule 2017 delaying the implementation of UDI requirements in India. Feedback was previously invited on an issued draft notification till December 28, 2021.  According to Rule 46 of the Medical Device Rules, new UDI regulations in India for the medical devices were to be displayed on the medical devices approved for manufacture, for sale, or distribution or import, by January 1, 2022. However, this has now been delayed until further guidance is provided.

With the current notification amending Rule 46, a new timeline will be specified by the Ministry of Health and Family Welfare in the future. MOHFW is also expected to provide guidance on how the Unique Device Identification number has to be displayed on the medical devices that are manufactured or imported and what information it needs to contain. While the requirements have been delayed for an unspecified amount of time, it is expected that additional guidance will be released in 2022.

As stated in the Notification:

Rule 46 of Medical Devices Rules, shall be substituted with:

“46. Unique device identification of medical device.— With effect from such date as the Central Government may, by order specify, every medical device approved for manufacture for sale or distribution or import, shall bear a unique device identification in the manner as may be specified in such order.”

While many international manufacturers have already implemented UDI, it will be important for manufacturers not already utilizing it to stay informed of new UDI regulatory updates in India.

New UDI Requirements to be Based on IMDRF Guidance

UDI requirements in India are expected to be based on IMDRF UDI Guidance which requires the label to include both a human readable form and an AIDC carrier. The Unique Device Identifier (UDI) is composed of two parts: Device Identifier (UDI-DI) and Production Identifier (UDI-PI). The IMDRF’s guidance is meant to help various markets harmonize their standards to support identification and distribution of products used by patients.

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Asia Actual is available to help navigate the complex and changing medical device registration requirements and regulatory pathway for medical device and IVD distribution in India.

Contact Asia Actual for a free consultation to discuss the potential of your medical device or IVD in the Indian medical market.

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