On 15 April, Health Canada published the Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing) in Canada Gazette, stating that by 29 June 2023, Manufacturers, Importers and Distributors may submit comments on the Canadian regulatory agency’s proposed updates to the Medical Device Regulation Directive (SOR/98-282) regarding the requirements for Medical Device Recalls and Establishment Licences (MDEL).

Currently, Health Canada uses guidelines to obtain the information necessary to assess the compliance of Medical Devices and to establish timelines within which the Manufacturer, Importer and Distributor must report any recalls to the Ministry of Health. However, these guidelines do not have the force of law and as a result Health Canada’s monitoring and oversight activities may be inadequate.

As a result, the Canadian regulatory agency has proposed amendments to the Medical Device Regulation (SOR/98-282), requiring recalls to be reported according to risk level and records to be maintained, and defining a person responsible for conducting them and informing Health Canada within 24 hours. The following are the proposed classifications:

  • Type I: there is a reasonable probability that the use of a recalled device will cause serious health consequences to a patient or user or their death;
  • Type II: the use of a recalled device is likely to cause temporary health consequences for a patient or user;
  • Type III: the use of a recalled device is unlikely to cause adverse health consequences for a patient or user.

Recall documentation must also include information on the recalled device, such as the name and address of the Manufacturer and Importer and the reason for the recall from the market; information regarding the recall strategy and corrective and/or preventive actions; and finally, the number of units of interest of the device.

With regard to Medical Device Establishment Licence (MDEL) to date, the Canadian regulatory agency could suspend the MDEL in the event of non-compliance with regulatory requirements. As a result, the organisation would have to cease all related marketing activities in the territory, thus negatively affecting the supply of Medical Devices in Canada and thus the health of patients. The proposed amendments to the Medical Device Establishment Licence (MDEL) would introduce greater flexibility, improve Health Canada’s ability to regulate such licences, and modernise the application requirements for such licences.

The proposed changes have caused little concern to Manufacturers, Importers and Distributors, who have stated that the timelines and expectations for reporting recalls are unclear and generate significant administrative costs. Furthermore, the current requirements are not aligned with those in other jurisdictions such as the US, EU, UK, Australia and Switzerland, causing misalignment issues for stakeholders and serious risks to human health.

In conclusion, the Canadian regulatory framework, to date, still presents several question marks that may limit Health Canada’s adaptation to a changing landscape and the development of an innovative and competitive market. With this in mind, the proposed changes aim to strengthen the regulation and oversight of the Canadian regulatory agency, improving its monitoring and evaluation capacity.

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>> Through its strategic regulatory consulting and document pre-screening services, Thema supports registrations with Health Canada (Medical Device Licence and Medical Device Establishment Licence).

For the registration of class II, III and IV devices, it is necessary to adapt the quality management system to the Canadian regulatory requirements and to obtain the MDSAP certificate. Rely on our experts to carry out the adaptation and support you before, during and after the Auditing Organisation’s inspection visit.

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