In the past few days, we have kept you informed about the importance of N95 mask certification, the measures put in place by the federal government to help Canadian businesses and the problems that can arise in the supply chain.
Has the situation improved? Today, the curve of the pandemic seems to be flattening in some parts of the world, but definitely not in the United States, our biggest trade partner. The situation in the U.S. could certainly delay the resumption of our business activities.
We are also aware that the Trump administration had prohibited 3M, a mask manufacturer, from exporting its products to Canada, even though some of the components originate from Canada. That decision was reversed on April 6.
Government authorities seem to be experiencing logistical problems when trying to procure medical equipment from around the world. Meanwhile, private companies should consider the possibility of using letters of credit to protect their finances when making a major purchase without having a guarantee of delivery.
Please note that Health Canada issues two types of licences for medical devices that are imported or sold in Canada:
- A medical device licence is required for all Class II, III and IV medical devices. Class I devices do not require a licence.
- A Medical Device Establishment Licence (MDEL) is required for manufacturers of Class I devices, as well as for importers or distributors of the four classes of devices.
Here are some examples of Class I protective equipment:
- N95 face respirators
- Gowns
- Masks
- Face shields
- Isolation units, pod or wards for infected or contaminated patients
- Nasopharyngeal tampons
A Medical Device Establishment Licence (MDEL) is required to import masks into Canada. For more information on how to obtain this licence, please contact one of our agents.
