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Medical device licence holders and importers of Class II to IV devices must notify Health Canada when there’s a serious …
Information needed for a submission to comply with the Regulations, licence holders and/or importers of Class II to IV medical …
Health Canada and the Canadian Advertising Preclearance Agencies (APAs) share the common goal of maintaining integrity in health product advertising. …
The objective of this guidance document is to assist industry and interested stakeholders (Market Authorization Holders (MAHs)) in developing a …
Health Canada recognizes that it is important for industry to disseminate non-promotional, accessible information on human and animal health products …
This guidance document was prepared to help medical device manufacturers understand and comply with the Medical Devices Regulations. Two new …
This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to …
This guidance document was prepared to help medical device manufacturers understand and comply with the Medical Devices Regulations. Two new …
Guidance to market authorization holders on issuing health product risk communications: Definitions.
The purpose of this document is to assist market authorization holders (MAHs) develop and disseminate health product risk communications (HPRCs).