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Exporting from the UK to Canada

Discussion in 'Medical Devices (21 CFR Part 820)' started by Shaun Me, Jun 1, 2018.

  1. Shaun Me

    Shaun Me New Member

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    Good morning - new member...

    I am looking for the process I require to export medical devices (Class I) from the UK to Canada and the USA.

    I have the certification (9001:2015) & (13485:2016)

    Its not clear on the web for the process I need to follow to ensure I can export devices to these countries ... conflicting info on what I have found. Can someone on the forum explain the route I need to follow. Any information would be appreciated including indications of associated cost for registering devices

    Thank you
     
  2. yodon

    yodon Active Member

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    This is by no means a complete reply but maybe can get you started and hopefully others will jump in.

    For Canada, you have to comply with the Health Canada regulations. Here's their main website: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html. I believe you have to register with them (and pay a fee). MDSAP is now a requirement in Canada (and it's QUITE costly).

    Similarly, in the US, you have to register (yes, a fee) and meet all applicable regulations. Here's a link to their website for importing: https://www.fda.gov/MedicalDevices/...ce/ImportingandExportingDevices/ucm050126.htm

    Hope that helps.
     

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