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Canada Makes Headway On Pilot To Test E-Submission Gateway; Guidance For 3D-Printing

 
• By Vibha Sharma

Canada will test the feasibility of receiving structured regulatory information from medical device sponsors through its common electronic gateway. Separately, a draft guideline on 3D-printed devices is in the works and is expected to be issued for consultation later this year.

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E-Submission Gateway Can Cut transmission Times And Cost • Source: Shutterstock

Health Canada is making progress with two medtech-related initiatives this year – one will allow certain device sponsors to submit advance regulatory information about their marking applications through the common electronic submission gateway (CESG) on a pilot basis from December 2018, and the other concerns draft guidance to support the licensing of 3D-printed medical devices.

The pilot on electronic submission of regulatory information was to be initially launched this summer, but it will now run...

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