Regulatory Open Forum

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  • 1.  Class I Canada

    Posted 02-Apr-2014 13:59

    Can a Class I product be sold in Canada if the distributor has an Establishment License but the Manufacturer of the Class I device does not have a CMDCAS ISO Certificate 13485?

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    Jennifer Terrell
    CareFusion
    San Diego CA
    United States
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  • 2.  RE:Class I Canada

    Posted 02-Apr-2014 14:11
    Ms. Terrell:

    If you can't get clarity on this from other RAPS members, I suggest you contact Gord Jepson, who is a partner in a Toronto law firm, Deeth Williams Wall.  Gord specializes in food & drug law from the Canadian perspective.  His contact information is:



    I have known Gord for a number of years and he is both top notch and a pleasure to work with.

    Best,
    Michael Swit

    ______________________________________________
    Michael A. Swit, Esq.
    Special Counsel, FDA Law Practice
    Duane Morris LLP
    750 B Street, Suite 2900
    San Diego, CA 92101-4681
    P: +1 619 744 2215
    F: +1 619 923 2648
    C +1 760 815 4762
    maswit@duanemorris.com

    Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

    Please follow me on LinkedIN and Twitter:
    http://www.linkedin.com/in/michaelswit
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    Original Message


  • 3.  RE:Class I Canada

    Posted 03-Apr-2014 08:53
    Class 1 devices do not require ISO 13485 with CMDCAS certification and as per Health Canada Guidance on MD Establishment Licensing... GUI-0016:

    2.0 Legislated Requirements

    Any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment licence with the exception of

    a manufacturer of a Class 1 medical devices who imports or distributes solely through a licenced establishment,

    Thus, you can sell the Class 1 devices through a licenced distributor.
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    Tim White
    Leadership, QA
    Abrasive Technology, Inc.
    United States
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    Original Message


  • 4.  RE:Class I Canada

    Posted 03-Apr-2014 05:46
    Dear Jennifer

    No medical device license needs to be obtained for a class I product (only medical device establishment license). For this, no certificate under CMDCAS (ISO 13485 + SOR/98-282) is necessary (only for class II, III, and IV).

    Best regards
    Beat

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    Beat Steffen
    Managing Director, Partner
    confinis ag - Project Mgmt & Consulting
    Auditor under CMDCAS
    Dudingen
    Switzerland
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    Original Message


  • 5.  RE:Class I Canada

    Posted 03-Apr-2014 09:22
    Yes, In order to sell class 1 products in Canada, you do not need to have CMDCAS ISO Certificate? You only need Establishment License. See point #4.

    For Class 1 Medical Devices, we are required to have Establishment license and mandatory procedures in place. We do not need to comply with ISO13485.

    Hope this helps.

    http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0016-eng.php

    5. Regulatory Exemptions

    Section 44(2) exempts the following persons from the requirement to hold an MDEL:

    1. retailers;
    2. health care facilities (as defined in section 1 of the Regulations.)
    3. in the case of Class II, III or IV medical devices, the manufacturer of the medical device (for which the manufacturer holds the Medical Device Licence).
      • However, if this manufacturer also imports or sells other medical devices (that are licensed by other manufacturers), then they must obtain an MDEL with respect to the importation or sale of those other medical devices for which they are not the MDL holders..
    4. in the case of a Class I device, the manufacturer of the medical device, if the manufacturer imports or distributes solely through a person who holds an MDEL.
      • However, if this manufacturer also imports or sells other medical devices, then they must obtain an MDEL with respect to the importation or sale of those medical devices.


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    Dona Bhamra
    Senior Quality Manager
    Motion Concepts
    Brampton ON
    Canada





    Original Message


  • 6.  RE:Class I Canada

    Posted 03-Apr-2014 11:24
    Thank you to everyone for your responses.  This is how I was interpreting the various sources of information however I wanted to be certain before I proceed.  This is very reassuring.  Take care everyone.

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    Jennifer Terrell
    CareFusion
    San Diego CA
    United States
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    Original Message