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  • 1.  CMDR SOR/2020-262 Question

    Posted 29-Jun-2021 17:28
    Hi there, I'm wondering if anyone could give me some feedback because I feel like I am missing something. We currently service a no longer sold Class I in Canada and I really have very minimal experience with Canadian regulations. 

    Is SOR/2020-262 technically an amendment to SOR/98/282? If so, will the SOR/98/282 title change to reflect the amendment, or is this more a stand-alone document?

    Ultimately what I am trying to do is demonstrate we have considered SOR/2020-262. Currently we list CMDR SOR 98/282. That listing doesn't denote accounting for SOR/2020-262. Any feedback would be appreciated and if I can provide any clarification please just let me know. Thank you.

    Andrew Devitt
    New Prague MN
    United States

  • 2.  RE: CMDR SOR/2020-262 Question

    Posted 29-Jun-2021 20:57
    SOR/2020-262 conveys a series of regulatory amendments for SOR/98-282 (as well as for the Food and Drug Regulations C.R.C., c. 870).  You can review my recent summary of the SOR/98-282 device regulatory changes here:

    The SOR/98-282 changes that took effect last week on 23 June 2021 are expected to be incorporated into the Justice Laws website version within a couple weeks.  The SOR/98-282 changes that will take effect 23 December 2021 will likewise be integrated in due course thereafter.

    The title of SOR/98-282 (Medical Devices Regulations) will remain unchanged.

    A good place to document consideration of applicable new or revised regulations is during management review.  For example, consideration of such regulatory changes is required as a management review input under ISO 13485 clause 5.6.2(l); a similar approach can certainly be applied even if it is not an ISO 13485 QMS.  It would be sufficient to record a high-level summary of such changes, and then a general implementation plan/timeline.  This would also be a good place to state the aforesaid relationship between SOR/2020-262 and SOR/98-282.

    Kevin Randall, ASQ CQA, RAC (Canada, U.S., Europe)
    Principal Consultant
    Ridgway, CO
    United States
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