Medical Device Regulations Model - Quality Smart Solutions

Medical Device Compliance Assistance in Canada and USA

Get Medical Device Compliance assistance to ensure that your product adheres to FDA and Health Canada medical device regulations so that you can cater to USA and Canadian marketplaces.

Medical Device Compliance in USA and Canada

Medical devices cover an array of medical or health instruments used to treat, mitigate, diagnose, or prevent a disease or abnormal health condition. These devices include pacemakers, hip implants, artificial heart valves, thermometers, syringes, contraceptive devices, and medical laboratory diagnostic instruments.

In Canada, medical devices are classified into one to four classes. Class I doesn’t require any medical device license, while Class 2, 3, and 4 require a license. In USA, medical devices are classified into Class I, II, and III. Most Class I devices are exempt from Premarket Notification 510(k) and most Class II devices need Premarket Notification 510(k); whereas Class III devices require Premarket Approval. All classes of medical devices in Canada and USA must be manufactured under Canadian medical device regulations and FDA regulations respectively.

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Shams W.Pawel Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Donal Gauvreau Sapro

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!

Why Need Medical Device Regulations in Canada and USA?

Both Canada and USA have the best regulatory systems in the world to assure that medical devices sold in these countries are safe and effective. Medical Devices Regulations of Health Canada and Center for Devices and Radiological Health (CDRH) of FDA monitor firms that manufacture, relabel, repackage, and import medical devices for sale. All classes of medical devices must be manufactured at a site that maintains quality standards such as ISO 13485 or equivalent in Canada. If the equipment is made outside Canada, the devices must comply with the quality standard and be brought into Canada by an importer who possesses a Medical Device Establishment License (MDEL).

Medical Device Establishment License

To manufacture, import, or distribute medical devices in Canada, you will need a Medical Device Establishment License (MDEL).

Establishment Registration

Domestic and foreign manufacturers, distributors, or importers of medical devices in USA must register their establishment with FDA.

Suspension of an Establishment Licence

Your establishment license will be suspended if you fail to comply with regulations, ‘present misleading statements’ in the application.

FDA Inspection

Every medical device manufacturing facility undergoes FDA inspection to ensure compliance with QS requirements.

Turnkey Medical Device Compliance Solutions in Canada

We serve our clients by providing Canadian medical device regulations, licensing, regulatory approvals. Customized solutions are available for manufacturers to set up a renowned medical device manufacturing facility.

License Class Determination and Registration

Our compliance officers assure your medical devices meet the Medical Devices Bureau regulations and a license is issued to you so that your device is listed on Health Canada’s public website.

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Medical Device Establishment License (MDEL) Registration

We assist during the entire process of manufacturing, importing, distributing medical devices, and meet ISO 13485 or 13488 standards to obtain a medical device establishment license (MDEL).

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In Vitro Diagnostic Devices (IVD) Registration

Are you interested in selling In Vitro Diagnostic (IVD) devices in Canada? If so, we will assist you in registering and obtaining IVD Medical Device License (MDL) from Health Canada.

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Expert Medical Device Compliance Assistance in USA

End-to-end compliance solutions are available at Quality Smart Solutions, including regulatory strategic planning, product classification, submission approval process, interaction with regulatory agencies during development stages, a detailed list of documents, diagrams, reports, or clinical data that are required for medical device registration.

510(k) Medical Device Registration

Our experts will review the entire testing requirements, go through applicable FDA guidance documents to meet required standards, and get your medical device registered.

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Medical Device Facility Registration and FURLS Listing

Get your facility registered with FDA. Our experts will help you get the FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM).

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In Vitro Diagnostic Device 510(k) Registration

We will help you submit your application for IVD (In Vitro Diagnostics) or file a Premarket Notification with the FDA, also known as an FDA 510(k). Call for step-by-step guidance.

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