Regulatory Open Forum

 View Only
  • 1.  Class II License in Canada for US device version

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jan-2023 09:40
    This message was posted by a user wishing to remain anonymous

    Hello everyone, 

    I am going to register some class II device in Canada. That device has already obtained 510(k) notification in the US. 
    I take this two options into consideration: 
    1) registration of the US version with the same article number as US device and same indications for use,
    2) registration of the ES version - other article number (as US device) and other indications. 

    For the US indications we are not able to provide the Clinical Evalation Report as the notification has been done through predicate device principle.
    Since Health Canada requested clinical evalution reports quite often in recent times, I am wondering if it is worhwile to register the US device version.

    Thanks a lot for your inputs! 


  • 2.  RE: Class II License in Canada for US device version

    Posted 30-Jan-2023 10:00
    Hi,
    Having a 510K clearance doesn't make it easy for Health Canada application. First from the question It is not clear if the device is class 2 or higher in Canada. For class 2 the effort for both your versions will be similar in terms of creating clinical evidence.
    for class 2 Health Canada - clinical evaluation report requirement, Health Canada would require: 
     clinical evidence from similar device with same intended use in Canadian market, not only that product design should be similar, but you can also provide published clinical literature to support using this device for the proposed indication.  Although this is a Class II device, the Regulations enable the Minister to request additional information and samples under section 35 during the application process. In this instance, section 35 would be used to request the submission of device-specific clinical evidence.

    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------



  • 3.  RE: Class II License in Canada for US device version

    Posted 30-Jan-2023 12:48
    Edited by Kevin Randall 30-Jan-2023 12:49
    It isn't possible to precisely answer questions about Canadian Class II device clinical data requirements without knowing precise details of the subject device (i.e., intended use, technological characteristics, etc.).  While there is correlation between U.S. FDA Class II devices and Health Canada Class II devices, there isn't always a 1:1 relationship.  Accordingly, the subject device needs to be classified using Health Canada's classification rules in their own right.

    In the absence of such organic details about the subject device, we can only apply Health Canada's corresponding regulatory requirements and practices.  For example,

    • As a general rule by regulation [CMDR Section 32(2)(c)], the conformity of a Canadian Class II medical device with the CMDR's safety and effectiveness requirements (Sections 10-20) is demonstrated in a Class II Medical Device License Application by way of a simple attestation that the manufacturer holds objective evidence (e.g., preclinical and clinical data/evaluation) establishing that the device meets the Section 10-20 safety and effectiveness requirements.  While CMDR Section 35 certainly does permit Health Canada the authority to deviate from this general rule, such deviations are in exception to the rule, and not the norm.  Many Canadian Class II devices can still be licenced without such exceptional submission of clinical data/evaluation.

    • In the exceptional cases where clinical data / evaluation are required in a Health Canada Class II Medical Device Licence Application, then Health Canada, in alignment with internationally standardized Good Clinical Practices (GCP) like ISO 14155, requires that the supporting clinical data must adequately represent the Canadian population and clinical practice, among various other requirements.  My understanding is that this does not necessarily mean that the clinical data must involve use in the Canadian market.  For anyone who would assert otherwise, it would be helpful if further basis can be given for such an assertion, which seems to be inconsistent with Health Canada's corresponding guidance and with standardized GCP.

    • Moreover, if we assert that supporting clinical must involve a similar device with the same intended use in the Canadian market, then that would seem to preclude any "new" medical devices ("new" = no similar devices with the same intended use in the Canadian market) from ever being licenced in Canada.  Such a requirement would never allow introduction of new technological or clinical advances.  Accordingly, I'm leery of such assertions.


    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Canada, U.S., Europe)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------



  • 4.  RE: Class II License in Canada for US device version

    This message was posted by a user wishing to remain anonymous
    Posted 31-Jan-2023 09:34
    This message was posted by a user wishing to remain anonymous

    @Rajeswari Devanathan and @Kevin RandallI I really appreciate your thoughs about my question. Thank you for your help!  ​​