FDA and Health Canada joint regulatory submission pilot
![](https://www.gmdnagency.org/wp-content/uploads/2023/07/Picture1-1.jpg)
15 January 2023
The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch the joint eSTAR pilot. Requests for participating in the pilot are now open.
The pilot will test the use of a single regulatory submission to both the FDA and Health Canada.
The submission will need to include the GMDN Term for the product and therefore will be useful for demonstrating how the GMDN supports international harmonisation using an accurate generic name for the device type. Requests for participating in the pilot are now open.
More information is available from the FDA and Health Canada.
Health Canada
US FDA
www.fda.gov/medical-devices/how-study-and-market-your-device/health-canada-and-fda-estar-pilot
Recent Posts
- Blog – The Importance of a Universal Definition for Medical Devices September 4, 2024
- GMDN Agency publishes white paper on the future of medical device nomenclature August 29, 2024
- Guest Blog – National Wound Care Strategy Programme: Enhancing Consistency with GMDN for Wound Management Products August 21, 2024
- GMDN FOCUS – Summer 2024 August 14, 2024
- South African founded company Discovery showcase how using GMDN benefits their work July 29, 2024