Canada Makes Headway On Pilot To Test E-Submission Gateway; Guidance For 3D-Printing
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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Health Canada is considering a pilot that should lead to medical device companies being able to use the common electronic submission gateway that is already in use by pharma. The gateway cuts transmission times.
A year and a half after FDA issued a draft guidance to help makers of devices that rely on additive manufacturing, the agency has finalized the document in its bid to get ahead of the technology. The final guidance makes minor clarifications, but for the most is identical to the draft.
The strict regulatory oversight that applies to conventionally produced implants would also start applying to similarly high-risk 3D printed implants under new proposals from Australia's Therapeutic Goods Administration.