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  • 1.  Canadian MDL - discontinuation

    This message was posted by a user wishing to remain anonymous
    Posted 14-Oct-2022 09:55
    This message was posted by a user wishing to remain anonymous

    Hello, 

    Should holders of a medical device license discontinue the sale of the medical device in Canada, should they discontinue the license upon the decision to stop importing and selling the device in Canada or do they have to wait at the expiry date of the last lot imported in Canada to allow distributor and retailer to deplete stock ?

    Thanks in advance for the feedback.



  • 2.  RE: Canadian MDL - discontinuation

    Posted 15-Oct-2022 14:27
    Edited by Karen Long 15-Oct-2022 14:27
    Hi there Anon,

    The guidance you seek is here. The renewal deadline is coming up Nov. 1 (see section 2.1.4). Failure to renew will result in cancellation of the license. 

    "If a medical device licence has been cancelled, the product is no longer permitted to be offered for sale in Canada. In order to bring the medical device back into compliance, the manufacturer or regulatory correspondent is required to submit a new medical device licence application, as well as pay all applicable fees."

    So if you fail to renew, you will be hanging your Canadian distributors and retailers out to dry. Can you recover the stock from them and sell it in another country? Or renew for another year to give them time to sell the stock? 

    Karen

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    Karen Long RAC
    Vancouver BC
    Canada
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    Original Message


  • 3.  RE: Canadian MDL - discontinuation

    Posted 17-Oct-2022 18:45
    I don't recall in the CMDR a provision for the manufacturer to cancel a device licence other than by way of the section 43(1) to 43(3) annual renewal process.

    In so doing, Karen's advice is great.  I'll add that section 26 of the CMDR gives corresponding regulatory insight where it reminds us that no person shall import or sell a Class II, III or IV medical device unless the manufacturer of the device holds a [valid] licence in respect of that device.​

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    Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 4.  RE: Canadian MDL - discontinuation

    Posted 18-Oct-2022 09:44

    Here is the provision in the CMDR: 

    43(3)     If the holder of a medical device licence discontinues the sale of the medical device in Canada, the licensee shall inform the Minister within 30 days after the discontinuance, and the licence shall be cancelled at the time that the Minister is informed.


    Upon making the decision to discontinue the sale, you have 30 days to inform HC. However, you do have to ensure that before you discontinue the licence, the product under the license is completely removed from distribution. You do not have to wait until expiry date to discontinue (if there is an expiry date).

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    Karen Zhou
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    Original Message


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