Regulations Amending the Medical Devices Regulations (Establishment Licences)

If you import or distribute medical devices in Canada, you'll now be required to submit your supplier list — including names, addresses, and device risk classifications — when you apply for your MDEL and every year at renewal. About 1,500 businesses that haven't been providing this voluntarily will face a first-year cost of roughly $400 to compile and submit the information, then about $70 per year to update it. On the positive side, Canadian importers who already hold an MDEL will no longer need to verify that their foreign distributors also hold one, reducing a compliance headache and opening up a larger pool of suppliers to work with. Businesses must also ensure they have written, implemented, and actively maintained procedures for safety activities like incident reporting, distribution records, complaint handling, and recalls — something Health Canada has found many companies are not doing adequately despite existing attestation requirements.