Introduction:
Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical devices are used to diagnose, monitor, or treat medical conditions in Canada and around the world.
The Canadian Medical Devices Regulations provide a framework for regulating medical devices that meet Health Canada’s standards. The regulations authorize the sale of safe and effective medical devices, help protect consumers by preventing unsafe products from being sold and ensure that manufacturers comply with good manufacturing practices (GMP).
What are the Medical Device Regulations in Canada?
The Medical Device Regulations is a set of rules that govern how medical devices are manufactured and sold in Canada. The MDL was enacted in 1993 and required manufacturers to notify Health Canada when they wanted to sell a new medical device in Canada. It also regulated marketing claims made by manufacturers about their products, including what information had to be provided on product labels and how well those labels were designed. In addition, it required manufacturers to provide information about their facilities for inspection by Health Canada before their products could be marketed or imported into Canada.
Since then, there have been two significant changes: one implemented in 2002 with the passage of Bill C-8; another enacted as recently as 2008 with Bill C-51 (you may have seen this referred to as legislation regarding “safe use”).
What are the Medical Device Regulations in Canada?
Health Canada Medical Device Licenses (MDL, MDEL). As a manufacturer or importer of medical devices in Canada, you must apply for a Medical Device Licence (MDL). If you wish to sell your device in Canada and import it into Canada, then you must also apply for a Medical Device Establishment Licence (MDEL). The MDEL is not required if only manufacturing is taking place in Canada or if only importing is taking place in Canada.
Who is subject to the Canadian Medical Device Licenses and Regulations (MDL, MDEL, SaMD)?
MDL, MDEL, and Software as a Medical Device (SaMD) apply to all manufacturers, importers and distributors of medical devices in Canada. Below are the descriptions of each type of licence:
– Medical Device Licence (MDL) – a licence issued to manufacturers authorizing them to import or sell their Class II, III or IV medical devices in Canada.
– Medical Device Establishment Licence (MDEL) – a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada.
– Software as a Medical Device” (SaMD) – software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
Do you need MDL, MDEL, or SaMD Assistance?
How Do I Get My Medical Device on the market in Canada?
To get your medical device on the market in Canada, you will need to:
– apply for an MDL for Class II, III or IV medical devices.
– apply for an MDEL if you manufacture Class I devices or import/distribute any device classes.
What is a medical device establishment license (MDEL)?
A medical device establishment license (MDEL) is a license issued to Class I medical device manufacturers as well as importers or distributors of all device classes (Class I, II, III, IV) to permit them to import or distribute a medical device in Canada.
What is a medical device license (MDL)?
An MDL is a license issued to manufacturers of medical devices authorizing them to import or sell their Class II, III, or IVD medical devices in Canada.
What are the different medical device classes in Canada?
There are four classes of medical devices in Canada:
- Class I devices are low risk and include simple equipment like bandages, or something like a tongue depressor.
- Class II devices are at moderate risk and include items such as blood pressure cuffs, stethoscopes, or thermometers.
- Class III devices are high-risk, but not life-sustaining or life-supporting (i.e., they don’t keep you alive). These include things like pacemakers and bone screws.
- Class IV devices are very high risk and usually must be implanted into patients’ bodies – things like breast implants fall into this category too!
Health Canada has a unique process for getting medical devices to market compared to regulations outside of Canada:
Health Canada has a unique process for getting medical devices to market compared to regulations outside of Canada. The Canadian medical device regulatory framework is a combination of the Medical Devices Regulations and licenses (MDL, MDEL, SaMD) and the Food and Drug Regulations (FDR). Health Canada is the regulatory authority that is responsible for the oversight of medical devices in Canada.
The Canadian medical device regulations have recently been updated to include rules for software as a medical device. This article provides an overview of what you need to know about medical devices so you can get your product on the market faster!
Conclusion
We hope that this post has helped you better understand the Canadian Medical Device Regulations and the licenses required to sell in Canada. If you want to learn more about our services and how we can help you get your product to market, please contact us today!
Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license. We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels.
Learn more about MDEL Registration, License Class Determination, In Vitro Diagnostic Devices (IVD) Registration, SaMD Classification and Registration, or our MDEL Import Agent service.
