Health Canada is proposing expanding the Terms and Conditions (T&Cs) on Class II to IV medical device licences to support the life cycle approach for regulating medical devices. This is […] Read More >>
Bringing a drug or a natural health product to market in Canada involves applying for an 8-digit numerical code, called a DIN for drugs, or an NPN for natural health […] Read More >>
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. While appearing similar to smallpox, it is […] Read More >>
On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations (FDR), introducing new regulations for supplemented foods as a category. These new regulations continue to protect […] Read More >>
New labelling requirements announced by Health Canada in Canada Gazette, Part II, Volume 156, Number 14 titled “Regulations Amending the Natural Health Products Regulations” have come into effect as of […] Read More >>
The cost to obtain an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada depends on the medical device’s classification. In this blog, we will break down […] Read More >>
Bioanalysis is the quantitative evaluation of analytes/substances in biological matrices such as tissue, blood, serum, urine, or other body fluids. Bioanalytical testing involves using a validated bioanalytical method for the […] 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 >>
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 >>
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 >>
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 >>
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 >>
In May of 2021, Health Canada announced a proposal to modernize the regulatory framework for Clinical Trials. This proposal hopes to help improve support the introduction of novel safe and […] Read More >>
In May of 2019, Health Canada announced a “Notice of Consultation on the Prescription Drug List: Vitamin D”. This notice opened up to public consultation the proposal to amend the Prescription […] Read More >>
In Canada, prior to July 1, 2020, drugs, which are inclusive of prescription drugs, non-prescription drugs (also called over-the-counter [OTC] pharmaceuticals), and natural health products (NHPs), were not permitted to […] Read More >>
Health Canada has recently released an Interim Order (IO) for the importation and sale of Class-IV medical devices used to diagnose, treat, or prevent COVID-19. **note: An interim order is […] Read More >>
Recent news about an employee testing positive for COVID-19 has prompted the Canadian Federal Inspection Agency (CFIA) to release update guidance about preventing and responding to COVID-19 in meat slaughter […] Read More >>
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