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.
Three companies are set to learn this week whether the European Medicines Agency will fast track its review of their soon-to-be-filed EU marketing applications.
Janssen and AstraZeneca are among a raft of companies that might this week find out whether the European Medicines Agency will recommend approval of their products for expanded therapeutic indications.