Health Canada, the country’s authority responsible for medical devices regulation, has published guidance describing the risk-based classification system to be applied for medical devices that are not in vitro diagnostic ones (non-IVDDs). The aspects related to the...
Health Canada, the Canadian authority responsible for the regulatory framework for medical devices and other healthcare products, has published guidance dedicated to the licenses an entity shall obtain to be allowed to perform certain regulated activities. In...
Health Canada, the Canadian regulating authority in the sphere of medical devices, has published guidelines dedicated to medical device shortages and actions to be taken by parties involved in this regard. In particular, the document describes measures to be taken in...
Health Canada, the country’s regulating authority in the sphere of medical devices, has published guidelines on special framework for importation and sale of medical device devices intended to be used in the context of the Coronavirus Disease 2019 (COVID-19) caused by...
Health Canada, the Canadian regulating authority in the sphere of medical devices, has published guidance on summary reports and issue-related analyses for medical devices. Summary Reports: Additional Aspects The present Health Canada guidance details the regulatory...
Health Canada, the Canadian regulating authority in the sphere of healthcare products, has issued guidance on summary reports and issue-related analyses for medical devices. Regulatory Background The regulatory requirements for importation, distribution and marketing...