December 5, 2021
Health Canada, the Canadian medical device market regulator, has published new guidance covering procedures and criteria for medical device manufacturers to report shortages and product discontinuations in order to protect the country’s medical supply chain.
The draft guidance complements recent amendments to the Canadian Medical Devices Regulations (CMDR) that add reporting requirements regarding device shortages for manufacturers licensed to sell their products in the country. These amendments take effect March 1, 2022.
What are Health Canada’s new medical device reporting requirements?
The CMDR amendments will require Medical Device License (MDL) and Medical Device Establishment License (MDEL) holders for certain Class I, II, III and IV devices to report shortages of their devices and/or device components and accessories to Health Canada. The amendments will also authorize the Canadian Minister of Health to require manufacturers, importers and/or distributors to provide data regarding device shortages.
Health Canada has issued a list of devices for which MDL and MDEL holders must notify Health Canada in the event of shortages. Examples of listed devices include:
- Class I: Surgical and medical masks, N95 respirators, face shields and medical gowns
- Class II: Ventilators, infrared and digital thermometers, medical gloves and aspirators
- Class III: Chest drainage systems, pulse oximeters, infusion pumps and dialyzers
- Class IV: Extracorporeal Membrane Oxygenation (ECMO) devices
Information to include in device shortage reports to Health Canada
Health Canada has identified minimum reporting information for submission in the event of actual or anticipated shortages, which should include the following:
- Manufacturer name and contact details
- MDL number for Class II, III and IV devices
- Device identifier data and name as it appears on label (in both English and French)
- Description of reason for actual or expected shortage
Voluntary reporting for device shortages
Although CMDR supply shortage reporting requirements will only apply to devices listed above, the guidance encourages manufacturers and other stakeholders to report shortages of devices not on the Health Canada list on a voluntary basis, as well.
Voluntary reporting would be especially appropriate in instances where shortages could cause patient or user safety issues; where compatible substitute devices, components or accessories are not available on the Canadian market; or where shortages occur on a national level.
Reporting timeframes to Health Canada
Manufacturers of Class I, II, III and IV devices identified on Health Canada’s notification list as well as importers of Class I devices are subject to the following reporting timeline requirements:
- Initial shortage reports are required within five business days of becoming aware of an actual or anticipated shortage
- Updated shortage reports are required within two business days of becoming aware of any changes or updates to information in an initial shortage report
- End of shortage reports are required within two business days after a manufacturer regains production ability to meet market demand for a device
- Medical device discontinuation reports are required within five business days following a decision to stop selling a device in Canada