This blog is meant to be an overview of the average costs associated with bringing a medical device to market under normal circumstances. Depending on when you are reading this […] Read More >>
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 >>
During the pandemic of respiratory disease caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or Coronavirus Disease 2019 (COVID-19), the FDA Commissioner may authorize the use […] Read More >>
COVID-19 tests are considered medical devices and are regulated under the Medical Devices Regulations in Canada. Medical devices are classified into 4 classes: Class I are those with the lowest […] Read More >>
In 2000, a group of professionals from the food industry gathered with the goal of collaborating and finding solutions for the food industry challenges, most notably to reduce food safety […] Read More >>
Regardless of whether you are developing a new food or dietary supplement/natural health product (NHP) that you intend to sell in either the United States, or Canada, you must follow […] Read More >>
Clinical research in Canada has seen a significant uptick in interest from Sponsors and Investigators since the onset of the COVID-19 pandemic. This interest is perhaps a precipitate of increasing […] Read More >>
Health Canada has recently notified the industry that TMAL (Temporary Marketing Authorization Letter) holders for supplemented foods (and caffeinated energy drinks) which are set to expire on December 31, 2021, […] Read More >>
If you are currently using a COVID-19 Site Licence to manufacture, package, label, or import alcohol-based hand sanitizers, your licence will expire September 30, 2021. Background In August of 2020, […] Read More >>
On July 16, 2021, Health Canada issued a Notice to Interested Parties about a Proposal to amend the Cosmetic Regulations.According to the notice, the Proposal is open to pre-consultation from […] Read More >>
A clinical trial protocol is a document that is designed to outline all details of a clinical trial. It is the main document referred to throughout the trial lifecycle and […] Read More >>
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