Canadian and Australian Medical Device Regulations
RGA6226 / 4 q.h.
Formerly RA 3226.
Explores the Common Technical Documents, General Guidance, GMPs, and Global Harmonization Task Force (GHTF) documents for medical device requirements in Canada and Australia. Offers students an opportunity to learn how to put together a medical device submission, identify two key submission pathways per product classification, and outline the postmarket requirements in both the Canadian and Australian markets.
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