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 >>
Last summer, Health Canada implemented the Plain Language Labelling criteria for non-prescription products and has mandated that by June 30, 2021, all products must be compliant at the retail level. […] Read More >>
Service(s) related to this article:  Food & Beverages Health Canada is proposing to restrict marketing unhealthy foods and beverages to children under 17 years. As part of Health Canada’s Healthy […] Read More >>
  Service(s) related to this article:  Food Safety & Quality, Food & Beverage, FSMA The latest deadline for the Food Safety Modernization Act (FSMA) just passed on May 30, 2017 […] 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 >>
November 23, 2016 State of California Adopts New Safe Harbor Warning Regulations With the rising public concerns regarding chemical exposure, transparent product labelling is an increasingly invested legislative topic in […] Read More >>
Advertising Standards Canada prepares revised guideline for claims that can be made on marketed health products with new guidance for medical devices and vaccines. On September 23, 2016 the Advertising […] Read More >>
As of the beginning of July 2016, the FDA has finalized the draft guidance document (originally drafted and released for consultation at the end of July 2015) on its policy […] Read More >>