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MDEL license amendment for addition of new class I device-Health Canada

  • 1.  MDEL license amendment for addition of new class I device-Health Canada

    Posted 09-May-2024 16:24

    Hi,

    We have a MDEL license which lists class I and class II device with the role of distributer and manufacturer. We also have the MDL license for class II device. We have a new class I device which is intended for Canada market. We have all the design documents available as per ISO 13485 and SOR 98-282. As far as I know, once we meet all the requirements of SOR 98-282 for class I device we can start selling the new device in Canada and there is no requirement for notification or amendment of such change.

    During annual license renewal for MDEL which happens before April 1st in the next year, we can add this device in the renewal form.

    Let me know if I am missing on something or if my understanding is wrong.

    Thanks