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Health Canada issues new Interim Order and addresses eligibility for RUO labelling The first Interim Order issued by Health Canada (HC) to govern the importation and sale of medical devices needed to diagnose or treat COVID-19 has expired, and the agency has put in place a new IO to seamlessly continue the provisions laid out in the first. The government body announced this plan i...

Health Canada issues progress report on its Medical Devices Action Plan Canadian medical device market regulator Health Canada has published a new round of updates regarding its Medical Devices Action Plan (MDAP), reporting progress not only on authorizations and approvals for coronavirus-related devices and clinical trials, but also for high-risk devices, investigation...

Health Canada Compliance In order to market health products in Canada, manufacturers, private labelers, importers and distributors must be in compliance with the Canadian laws and regulations for marketing of food, drugs and medical devices. The federal regulatory authority responsible for the sale of medical devices and dr...

Health Canada’s COVID -19 Medical Device Database Can Be Very Misleading If you are involved in the importation or distribution of Medical Devices related to the COVID crises in Canada, then no doubt you are aware of Health Canada’s online database that goes under the name “Authorized medical devices for uses related to COVID-19”. Unfortunately, this database, howe...

ISO 13485 READY TO USE SOP TEMPLATES | MANUFACTURERS CLASS II & ABOVE Our Audit-ready ISO 13485:2016 Documentation Toolkit We offer ISO 13485:2016 Documentation Toolkit, which is a set of ready-to-use templates designed as per general version of standard requirements. Our readymade ISO 13485 documents includes the following: ISO 13485 Quality Manual ISO 13485 Standard...