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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.

Better
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through the common electronic submission gateway (CESG) on a pilot basis from December 2018, and the other concerns draft guidance to support the licensing of 3D-printed medical devices.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 from Dec. 1 to May 2019. (Also see "Electronic...

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23andMe Purchase Will Let Regeneron Scale Drug Development

 
• By Alaric DeArment

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Disparities — Including Financial Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.