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  • 1.  distribution to canada

    Posted 16-Apr-2018 12:00
    ​​My company is in discussion regarding distribution of product to the Canadian market.   What differences should be expected from a regulatory perspective to distribute in Canada versus EU and US?

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    Gwendolyn Lohr
    Regulatory & Compliance Specialist
    United States
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  • 2.  RE: distribution to canada

    Posted 17-Apr-2018 05:38
    Gwendolyn,

    Depends on the class of device, but generally Class II, III, and IV it has become more difficult.  With the requirement now to have an ISO 13485 certified system + MDSAP this has put a tremendous cost and time restraint on companies trying to enter the Canadian market.  Class II, III, and IV devices require as part of the application an ISO 13485 cert + MDSAP (well CMDCAS until 1 Jan 2019) which differs slightly from the EU model which the least burdensome approach is ISO 13485 certification + MDR requirements (Article 10, Annex IX through IX).  The United States surprisingly today and at least in the next 3 to 5 years ... unless they change something drastically ... is least burdensome for putting products on the market, initially.  An FDA inspection can be done at any time after registering which can still be a significant event, but U.S. does not require ISO 13485 certification prior to marketing the device (... yet :) ).

    For a Class I device in any of these markets, it is typically a self-declaration or self-certification.  Such as in Canada you apply for a Medical Device Establishment License, but in Canada this can also be very expensive, so large volume is usually needed to justify the cost.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: distribution to canada

    Posted 17-Apr-2018 10:51

    Hi,

    As Richard mentioned above, the exact regulatory requirements depending on the device class (if by "product" you meant a "medical device"?).

    In a nutshell:

    1. Licence requirements:
      • You will need to classify your product according to the Canadian regulation (SOR/98-282 - Schedule 1) which is similar but not identical to the EU classification rules.
      • If the device determined to be class II-IV, it would require having a Medical Device License (MDL) issued by Health Canada prior to importing/selling the device in Canada. Class I devices are exempt, self-declared (SOR/98-282 - Section 26). The complexity of the submission and the review time heavily depends on the device class.
    2. Establishment requirements:
      • To operate in the Canadian market importers and distributors of all classes of devices, class I manufacturers and manufacturers who import/sell devices for which they are not the legal manufacturer must have an establishment licence (MDEL) (SOR/98-282 - Section 44).
    3. Change to a licensed device:
      • Each change to a class III-IV licenced device should be assessed whether or not the change is a Significant Change by applying the principles of Health Canada Guidance for the Interpretation of Significant Change of a Medical Device.
      • If the change is deemed to be a significant change; the licence should be amended. If the change was found not to be significant but is related to the information submitted by the manufacturer with respect to the device licence application, then the changes must be reported to Health Canada at the time of annual licence renewal.
    4. QMS certificate:
    • Starting Jan 1st 2019, in order to sell a medical device in the Canadian market you will need to have an ISO 13485 + MDSAP certificate (replaces the current Canadian Medical Devices Conformity Assessment System (CMDCAS).
    Tal

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    Tal Bresler, PhD.RAC

    Toronto, On, Canada
    tal.bresler@gmail.com
    https://www.linkedin.com/in/talbresler/
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    Original Message


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