The US Food and Drug Administration has published a highly anticipated proposed rule to harmonise its medical device quality management...

The first Interim Order issued by Health Canada (HC) to govern the importation and sale of medical devices needed to diagnose or treat...

Canadian medical device market regulator Health Canada has published a new round of updates regarding its Medical Devices Action Plan...

In order to market health products in Canada, manufacturers, private labelers, importers and distributors must be in compliance with the...

If you are involved in the importation or distribution of Medical Devices related to the COVID crises in Canada, then no doubt you are...

Health Canada (HC) announced plans to leave several Interim Orders relating to the COVID-19 pandemic in place until fall of next year....

Medical Device License (MDL) and Medical Device Establishment License (MDEL) are the licenses issued by Health Canada, the Health Agency...

Medical devices and in vitro diagnostic devices (IVDs) are regulated By Health Canada (HC), under the Canadian Medical Devices...

New rules for having fun at parks and other recreational (Protect Yourself and Others from COVID-19) Staying physically active is one of...

As the COVID-19 pandemic continues to challenge the Canadian healthcare system, concerns have been raised about potential shortages of...

Applicants, may it be the manufacturer, importer, or distributor must obtain a license before their product is released to the Canadian...

In order to get FDA clearance for you product, you need to comply with one or more of the following requirements: Establish and maintain...

Medical devices is one of the fastest growing areas within life sciences. This broad industry develops all manner of devices from...