Resources

Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

Download the Chart on the Medical Device Approval Process in Canada
Health Canada Regulatory Approval Process for Medical Devices
To obtain access to the Canadian market, medical device manufacturers will need to secure a license. Health Canada issues two types of licenses: the
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WATCH NOW: Overview of the MDSAP Certification Process
WATCH NOW: Overview of the MDSAP Certification Process
The Medical Device Single Audit Program (MDSAP) offers a way to streamline the pre- and post-market audit process required by medical device
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Introduction to Canada's medical device registration process
Canada is a well-established but lucrative market for medical devices. It has one-fifth the population of Brazil, but spends nearly as much on
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Preparing a Canadian MDL Application
So you have one or more cleared medical devices in the US and now you want to license them in Canada. While the Canadian registration system seems
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Download the free chart: Canada IVDs Regulatory Approval Process for Medical Devices
Health Canada Regulatory Approval Process for IVDs
The chart shown illustrates the Health Canada approval process for In Vitro Devices (IVDs) and is available for download in PDF format. However, if
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Fill out our short form to request information about Canada
Get smart about Canada in 1 hour
If you are thinking about entering the Canadian market for the first time, understanding Health Canada’s regulatory requirements can be overwhelming
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Medical device QMS compliance in Canada
Achieving QMS compliance in Canada for medical device and IVD companies
This white paper will discuss the requirements for achieving compliance with the Quality Management System (QMS) regulations as they apply in Canada
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ISO 13485:2016: Six Key Differences for Medical Device Companies
The publication of ISO 13485:2016 introduced significant changes for device manufacturers around the world. Some changes are specific, while others
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