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  • 1.  Canadian Med Dev QS Requirements

    Posted 14-Jun-2013 10:50
    Is anyone aware of a concise listing showing additional requirements for Canada above and beyond a company that meets 21CFR820 + ISO 13485? Thanks in advance.

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    David Kollen
    Vice President, Quality & Regulatory Affairs
    Inova Labs
    Austin TX
    United States
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  • 2.  RE:Canadian Med Dev QS Requirements

    Posted 14-Jun-2013 11:14
    You need Health Canada's guidance document GD210.
    http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/cmdcas_scecim_audit13485_gd210-eng.php
    This does a good job of making clear the additional requirements.

    Bill

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    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States
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    Original Message


  • 3.  RE:Canadian Med Dev QS Requirements

    Posted 14-Jun-2013 11:32
    David,

    This may be of help.

    Health Canada ' GD210: ISO 13485:2003

    http://wp.me/P33LGu-uK



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    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message


  • 4.  RE:Canadian Med Dev QS Requirements

    Posted 17-Jun-2013 10:48
    Dear David

    In my opinion the following.
    For Canada you need an CMDCAS Certificate related to ISO 13485. CMDCAS = Canadian Medical Devices Conformity Assessment System.
     In Europe this certificate is issued out by the certification (notified) Body and they use a seperate Audit question list. It would may a good option to ask your certification Body for this questionnaire. In addition you have to place an order for this optional Audit.

    You will find further Information here: http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/cmdcas_scecim_syst_pol-eng.php


    hope this helps

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    Carsten Keller
    Director QM/RA
    SOPRO-COMEG GmbH
    Tuttlingen
    Germany
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    Original Message