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Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management

Mark Meer

Trusted Information Resource
#1
Health Canada issued this notice of intent back in April regarding "Strengthening the post-market surveillance and risk management of Medical Devices".

As written in the notice, most of the proposed changes are written in the format "Provide the Minister with the authority to...". Does this mean that the proposed changes simply give Health Canada authority to request things in certain circumstances but, in the absence of these circumstances, nothing new is mandated (e.g. no changes to procedures, requirements for additional documentation to be maintained, etc.)?

In otherwords: although the changes imbue Health Canada with additional authorities, for most manufactures it'd just be business as usual?

Is this interpretation of the intent correct?
 
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