Canadian Guidance Clarifies New Formats For Marketing Applications
Health Canada is planning to adopt the International Medical Device Regulators Forum’s Table of Contents formats as of April 1.
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Canada's Switch From CMDCAS To MDSAP Went Off Without A Hitch – Despite 403 Firms Leaving The Market
It's been one full month since the Medical Device Single Audit Program officially replaced the traditional Canadian Medical Devices Conformity Assessment System (CMDCAS) audits, and Health Canada is claiming success. Although 403 device-makers withdrew from the Canadian market because of the switch to MDSAP, it's nothing to be concerned about, a Health Canada spokesperson says.
Companies have the opportunity to tell the European Commission what they think about its proposed regulation that would overhaul the rules governing the use of substances of human origin.
Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.