What you need to know about Health Canada’s Regulatory Amendments for Non-Prescription Drug Products (GUI-0001)

Health Canada's regulatory amendment to the Food and Drugs Regulations Guidance Document GUI-0001 came into effect on July 1st as part of the Canada-United States-Mexico Agreement (CUSMA) and replaces the previous 2018 edition. The new amendments emphasize finished product testing of non-prescription drug products and directly affects importers and [...]

August 6th, 2020|Categories: Pharmaceuticals|

Importing foods into Canada under the new Safe Food for Canadians Regulations for Manufacturers

The Safe Food for Canadians Regulations (SFCR) was finalized in June 2018 with phase one coming into force on January 15, 2020 for fresh produce companies, and phase two on July 15th for the manufacturing sector.  The goal of the new rules is to capture all aspects of food [...]

July 21st, 2020|Categories: Food and Beverage|

Modified Approach to Posting Medical Device Recalls Online

As part of Health Canada’s risk-based approach to ensure its transparency efforts are focused on Canada’s most important health concerns, including those related to COVID-19, the Department has updated its approach to posting medical device recalls online. As of June 22, 2020, Type III medical device recalls are no [...]

July 3rd, 2020|Categories: Medical Devices|

CFIA temporarily lifts food labeling requirements and re-prioritizes “low-risk” compliance activities due to COVID-19

The Canadian Food Inspection Agency (CFIA) yesterday temporarily lifted certain food labeling restrictions that have no impact on food safety as an initiative to support the economy, alleviate supply disruptions in Canadian grocery stores, and avoid food waste due to COVID-19. This is making way for retail sale of [...]

April 8th, 2020|Categories: Food and Beverage|

Health Canada’s Final Guidance on Software as a Medical Device

On December 18, 2019 Health Canada published a guidance document on Software as a Medical Device (SaMD): Definition and Classification. The role of the document is to clarify to manufacturers and software developers whether their software product meets Health Canada’s definition of a medical device and if so, its [...]

February 11th, 2020|Categories: Medical Devices|

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