Health Canada, the Canadian authority that deals with Medical Devices, has recently made some significant changes to the regulatory system.

In addition to the annual fee increase, the presentation method of some registration applications have also changed and forthcoming changes to Quality System requirements are expected.

But, we should move one step at a time, finding out what has changed and what we need to know in order to adapt to the forthcoming news in time. In particular, there are three updates not to be missed:

  • The new fee list to be paid to Health Canada for several practices relating to the medical device sector came into force on April 1, 2017. As usual, fees increased by 2% compared with the previous year. Hereafter, the updated amounts expressed in Canadian dollars to be paid to Health Canada for new registrations:
    • Class II New License Application: $397
    • Class III New License Application: $5,691
    • Class IV New License Application: $13,235
  • Moreover, Health Canada has extended to all device classes the need to submit the registration applications exclusively in electronic format beginning April 1, 2017. It is therefore no longer possible to submit paper documentation to complete the transitional period established by the guidance published in February 2016. The “Preparation of Regulatory Activities in the “Non-eCTD Electronic-Only Format” guidance includes the requirements for the registration dossier structure, content and format in accordance with the non-eCTD electronic format.
  • Finally, as of January 1, 2019, Class II, III, IV Medical Devices manufacturers who intend to market their products in Canada will have to adapt to the MDSAP program. Health Canada established a transition period from the current CMDCAS program to the new MDSAP: from January 1, 2017 to December 31, 2018. During this transition period, the Canadian regulatory authority will recognize both the certificates issued under the CMDCAS system and the new certificates under the MDSAP system.

However, starting from January 1, 2019, the product licenses acquired by providing a CMDCAS certificate that are not validly supported by an MDSAP certificate will be suspended.

Recent data provided by Health Canada point out that less than 10% of the involved manufacturers have already applied for the MDSAP certification. Given the impact on the Quality System and the commitment required by an MDSAP audit, both in economic and time terms, it is worth making the necessary evaluations to avoid being unprepared on January 1, 2019!


Read also “Strategy and quality: a glimpse at the future” and “How to avoid the commercialization of Medical Devices strategically (and tragically) at random” in our Blog.
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Simona Daidone
RA Manager