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Medical Devices

As per the Food and Drugs Act, manufacturers must obtain a Licence for certain health products qualified as « device » before they can put them on the Canadian market.

In order to determine which device must be licensed, all medical devices have been classified relative to the risk associated with their use. Before selling a Medical Device in Canada the manufacturers of Class II, III and IV Medical Devices must obtain a Medical Device Licence (MDL).

Although Class I Medical Devices do not require a Medical Device Licence, manufacturers, distributors and importers of Class I Medical Devices must obtain a Medical Device Establishment Licence (MDEL).

Normand Robichaud Services conseils inc. can assist you in the following areas:

  • Preparation, filing and follow-up of Medical Devices market authorization (Medical Device Licence) submissions with Health Canada.
  • Communication, liaison and follow-up with Health Canada concerning Medical Device Licences modifications or amendments.
  • Guidance and assistance with your Medical Device Licence submissions to Health Canada.
  • Preparation, filing and follow-up of Medical Device Establishment Licences (MDEL) submissions and amendments.
  • Guidance and assistance with your Medical Device Establishment Licence submissions (MDEL) to Health Canada.
  • Act as your Regulatory Compliance representative in Canada.