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Gold/Mining/Energy : Zentek Ltd.
ZEN.V 1.200-0.8%2:46 PM EDT
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From: Candu10/28/2025 9:28:31 AM
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A little info on our wait for a decision from Health Canada...

Current status
  • The Notice of Intent was published: the consultation period is over (stakeholders had 30 days). Canada.ca+1

  • No public record (in the sources checked) yet of the final regulatory amendment being enacted (i.e., the exemption formally coming into force) as of the latest information.

  • As of now, the proposal remains “in progress” — meaning the rules haven’t yet changed for Class I devices, but the path to that change is laid out.

?? What this means for manufacturers / stakeholders
  • Until the amendment is in force, Class I devices treated with antimicrobials remain subject to the PCPA (through the PCPR) despite the upcoming change.

  • If the amendment goes ahead, this will reduce duplication of regulatory oversight (devices regulated as medical devices under the MDR would no longer also fall under the PCPA for the antimicrobial-treatment aspect) for Class I devices.

  • Stakeholders that have Class I devices treated with antimicrobial preservatives should monitor the formal regulatory change (i.e., check when the amendment is published in the Canada Gazette and when it takes effect) and prepare for that transition.

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