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 >>
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 >>
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 >>
If you are involved in the importation or distribution of Medical Devices related to the COVID crises in Canada, then no doubt you are aware of Health Canada’s online database […] Read More >>
The temporary exemptions for the importation of hand sanitizers, which was announced March 27, 2020, as part of the Natural and Non-Prescription Health Products Directory (NNHPD)’s interim measures have now […] Read More >>
In addition to governing pharmaceutical and medical device research, Health Canada provides oversight and approval of nutraceutical clinical research and natural health products conducted in Canada. This integrated approach allows […] Read More >>
The Food and Drug Administration (FDA) recently published a new guidance document to help expand the availability of surgical apparel, including gowns, hoods, and surgical & patient examination gloves, in […] 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 >>
On April 1, the Ontario Government announced a $50 million fund called “The Ontario Together Fund” which is intended to help businesses produce essential medical products amid the COVID-19 pandemic. […] Read More >>
The COVID-19 pandemic has precipitated an unprecedented public health situation in the United States of America, disrupting supply chains and creating shortages of products aimed at preventing infection. As a […] Read More >>
The team at dicentra has been closely monitoring the COVID-19 pandemic and has been active in taking the necessary steps to help protect the health and safety of both our […] Read More >>
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