The new European Union In Vitro Diagnostics Regulations (EU IVDR) entered into application on May 26, 2022, to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC). Manufacturers, authorized representatives, importers, and […] Read More >>
In vitro diagnostic medical devices contain a broad spectrum of devices that test biological samples to determine the status of one’s health, from self-tests for pregnancy, to blood glucose tests […] Read More >>
EFSA’s Strategy 2027 delineates the European Food Safety Authority (EFSA) strategies and approaches in responding to the changing environment in the years ahead, especially in light of the SARS-CoV-2 global […] Read More >>
Health Canada’s use of Interim Orders (IOs) has allowed for the exceptional importation and sale of Medical Devices (MDs) to help prevent shortages in relation to COVID-19. To date, Health […] Read More >>
Medical devices in the European Union (EU) are approved through a different mechanism than the approval process in the United States or Canada. The approval of medical devices intended for […] Read More >>
As innovation continues to evolve in digital health technologies, Health Canada is undertaking an adaptive initiative to support better access to those therapeutic products, especially in relation to medical devices. […] Read More >>
Digital Health covers a broad scope of categories in mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Digital health tools range from mobile medical […] Read More >>
Health Canada has announced December 14, 2022, as the new date for when the Canadian Food Inspection Agency’s (CFIA) updated food labelling regulations (which came into effect on December 14, […] Read More >>
You have probably heard of the terms IND and NDA being used during drug development and applications. People tend to get confused between the two terms and wonder how they […] Read More >>
In regulatory affairs, a dossier is a term used to describe a compilation and array of documents regarding the safety, efficacy, and quality information of a medical product. The dossier […] Read More >>
One of Health Canada’s largest initiatives in the past few years has been the Self-Care Framework, which implements a different approach to regulating products, that are purchased and applied directly […] Read More >>
Health claims are integral to the success of Natural Health Products (NHPs) here in Canada. They provide products with a competitive edge in the marketplace and consumers with the information […] Read More >>
  Service(s) related to this article:  510K & Canadian Medical Device Consulting As you are planning the commercialization of a new medical device for the US market you will want […] Read More >>
  Service(s) related to this article:  Food & Beverages and  Product Development & Label Compliance Health Canada has released a notice of proposal describing the regulation of prohibiting the use of […] Read More >>
STAY ALERT AND AWARE OF PENDING CHANGES THAT MAY IMPACT YOUR BUSINESS How does the Food Safety Modernization Act affect your business? What do the latest guidance documents say? What are […] Read More >>
  We have received notice that the Natural and Non-prescription Health Products Directorate (NNHPD) will initiate a new policy with respect to post-licence audit failures. The NNHPD implemented a new […] Read More >>
SPECIAL ALERT November 10, 2015 As part of its ongoing post-licencing audit program, Health Canada has raised concerns with products that contain both caffeine and any ingredients that could possibly […] Read More >>
  Health Canada requires that industry conduct due diligence on their consumer products through safety assessments and labelling to ensure that do not pose harm to consumers. Under Canada Consumer […] Read More >>
The 6 month calendar of NNHPD activities for natural health products provides updates on new monographs and guidance documents. The Natural and Non-Prescription Health Products Directorate (NNHPD) has released its […] Read More >>
Big Changes Around the Corner for All Foods in Canada Safe Foods for Canadians Regulations and Licensing Requirements The most significant change in the history of Canadian Food and Drug […] Read More >>