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 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.
Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with Health Canada
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).
To manufacture, import, or distribute medical devices in Canada, you will need a Medical Device Establishment License (MDEL).
Domestic and foreign manufacturers, distributors, or importers of medical devices in USA must register their establishment with FDA.
Your establishment license will be suspended if you fail to comply with regulations, ‘present misleading statements’ in the application.
Every medical device manufacturing facility undergoes FDA inspection to ensure compliance with QS requirements.
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.
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.
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).
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.
Register your SaMD with Health Canada with the help of our software device licence professionals. We help based on risk evaluation, inclusion and exclusion criteria.
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.
Our experts will review the entire testing requirements, go through applicable FDA guidance documents to meet required standards, and get your medical device registered.
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).
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.
Wondering how to register your SaMD with FDA? Our software device licence experts will help you register your SaMD with FDA based on risk evaluation, inclusion and exclusion criteria.
We have licensed a wide range of Medical Devices, including but not limited to below
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