Market access of medical device (IVD) in Canada
Canada has revenue of medical device US $11.02bn in 2024 (statisca). With 40 million Canadians, the market is one of the most attractive in North America.
The authority is health Canada which is responsible for drug, health products, food and nutrition. Medical device is one good example of health products.
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Legislative of Canadian registration of medical device and In Vitro Diagnostic Devices
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The highest law of medical device is Therapeutic Products Directorate and Medical Devices Regulations.
The last one is extreme useful to look after anything legislative with given table of content. There is unique all in one page link containing all supporting guidances. As well for recognized standards to mention at product registration there is one practical website.
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There are 4 classes of medical device: I, II, III and IV.
Only for class II, III and IV, manufacturer has to show evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. General speaking, as of January 1, 2019, the Medical Device Single Audit Program (MDSAP) will be the only mandatory program recognized by the Minister of Health.
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Technical documentation of medical device as example
Health Canada adapted assembly and technical guide for IMDRF table of contents submissions. It means the technical documentation is clear in Canada as showed in figure. There is technical guidance for requirements, folder structure, folder naming convention, file format and naming etc.
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The technical documentation to submit is very similar to FDA, however with detailed structure. It should be easier to switch from a 510k or PMA dossier than MDR technical documentation to Canadian technical documentation.
Below is table of content of technical documentation of medical device for class IV (non-in vitro diagnostic devices) illustrated.
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After approval activities after approval of medical device (IVD)
The typical activities are to report serious adverse event and recalls. Besides, it is obligatory to submit “summary reports”.
The time line for “summary reports”:
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for medical device licence holders of Class II devices: every 2 years with information gathered during the previous 24 months
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for medical device licence holders of Class III and IV devices: every year with information gathered during the previous 12 months
What happens if product is under changes? In Canada there are clear change applications of medical device, from low to high demand:
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Licence Amendment Fax-Back Form for Changes to the Name of a Device Licence
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Medical Devices Licence Amendment Minor Change for Changes to the Manufacturer's Name and / or Address of Existing Device Licences
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Medical Devices Licence Amendment Fax-back For Non-significant Additions/deletions
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Medical Device Licence Amendment