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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

    Jun 1, 2018
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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 Well-Known Member

    Aug 3, 2015
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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.