Medical Devices Regulations updated: new shortage-reporting, discontinuation-posting and quality-procedure rules for device industry

Plain-language summary · AI-assisted

Canada's Medical Devices Regulations have been amended in several practical areas. Manufacturers, importers and distributors of 'specified' medical devices (those on a government-maintained list) must now publicly post advance notice on a designated website when they plan to discontinue Canadian sales — at least 12 months ahead if the decision is made more than 12 months out, or within five days otherwise — and must also post shortage notices with updated timelines for anticipated supply gaps. A new requirement (section 62.311) means anyone selling a designated medical device at retail must make bilingual use-information available to consumers at point of sale. Establishment licence holders that import 'designated' medical devices under the exceptional importation pathway now have a shorter pre-import notification window (three business days, down from five), must notify the Minister within 72 hours if the device loses its foreign regulatory authorization, and face new recall-like obligations tied to foreign regulatory status changes. Manufacturers, importers and distributors must also now document and maintain written procedures for distribution records, handling/storage/delivery, incident reporting, and (for Class II–IV devices) corrective action. Establishment licence applications and renewals require new information about non-manufacturer sellers in the supply chain.

Who this affects
medical device manufacturers · medical device importers · medical device distributors · establishment licence holders · retail sellers of medical devices