Summary
Canadian medical device regime: classification (I-IV), medical device licence (MDL) or establishment licence (MDSEL), quality system (ISO 13485 / CAN/CSA).
Scope
Applies to medical devices sold in Canada (SOR/98-282). Requires: class I establishment licence + medical device licence (classes II-IV), quality system requirements (ISO 13485), labelling (s. 21-23), adverse reaction reporting.
Expert analysis
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