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.
You may also be interested in...
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.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The medicines and medical devices regulator hopes to appoint a new CEO by the autumn to take over from Dame June Raine, under whose leadership the MHRA became the first agency in the world to authorize a COVID-19 vaccine.