Canada and Other Countries
The results of European efforts spent writing elegant medical device directives have been picked up by other countries. The directives are important contributions to the global harmonization. Many countries have adopted the underlying principles in their national laws. Examples include: Australia, Canada, Central and South America, Taiwan, Japan, Russia.
We believe that if you have your Technical Construction File and Quality System approved for the European market, you have at least 95% in place for access to other countries. Some minor differences of course exist. Incident reporting, classification, labeling and language requirements come to mind.
IQA has specific knowledge regarding the interpretation of Health Canada’s – Medical Devices Regulations.
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