On July 3, 2024, Regulation SOR 2024-136 was published in the Canada Gazette, an update that makes significant changes to SOR/98-282 concerning certain requirements for medical device recalls and the MDEL (Medical Device Establishment Licence). The revision introduces new obligations for manufacturers, importers and distributors of Medical Devices operating in Canada and will enter into force on December 14, 2024 (180 days after its release).
Content of the Amendments
The changes made by SOR 2024-136 aim to improve product recall management and MDEL licence compliance.
Some of the novelties regarding recalls include:
- Updated definition of recall including recalls initiated by manufacturer, importer and ordered by Health Canada.
- During the recall process, companies shall provide more detailed and timely updates to the regulatory authorities, reporting the recall notification within 24 hours of the decision to implement the action.
- Among the many pieces of information to be reported are: the name and ID of the device, the name of the manufacturer and importer, the reason for the recall and a preliminary risk assessment of the defect or potential defect.
Applicants and holders of MDEL (Medical Device Establishment Registration) licences will be subject to stricter quality and risk management criteria:
- More control and more demands from Health Canada.
- Updated procedures for implementing effective corrective actions.
- Changes in content and timing of contact information to be transmitted.
Implications for Medical Device Manufacturers
The entry into force of SOR 2024-136 will have a significant impact on all organisations that market Medical Devices in Canada, as manufacturers are required to quickly update their quality management systems to align with the new standards. It will be crucial to implement stricter monitoring processes to ensure that Medical Devices placed on the market fully comply with safety requirements.
In addition, companies will have to invest in more staff training to adapt to the new standards required, particularly regarding recall management and MDEL licence compliance.
Deadlines and Preparation
With the entry into force scheduled for December 2024, companies have a period of six months to prepare and adapt to the new provisions. This time interval should be used to evaluate and update existing procedures, thus ensuring full compliance by the deadline.
In conclusion, SOR 2024-136 represents a further step forward in the regulation of the medical device industry in Canada, intending to enhance product safety and consumer protection.
Companies are now called upon to move quickly to ensure that they comply with the new obligations and to avoid possible sanctions or delays in marketing their products.
>>> Thema’s experts are thoroughly familiar with all the requirements of SOR 2024-136 and are available to accompany your devices on the Canadian market in compliance with the regulations.
SOURCE:
https://canadagazette.gc.ca/rp-pr/p2/2024/2024-07-03/html/sor-dors136-eng.html
