Medical devices in Canada cover health and medical instruments such as pacemakers, hip implants, artificial heart valves, thermometers, syringes, contraceptive devices, and medical laboratory diagnostic instruments.
Medical devices in Canada are classified into one of four classes. While Class I does not require any medical device license, Class 2, 3 and 4 do. All classes of medical devices in Canada must be manufactured under the Canadian medical device regulations.
Medical devices in Canada cover health and medical instruments such as pacemakers, hip implants, artificial heart valves, thermometers, syringes, contraceptive devices, and medical laboratory diagnostic instruments.
Medical devices in Canada are classified into one of four classes. While Class I does not require any medical device license, Class 2, 3 and 4 do. All classes of medical devices in Canada must be manufactured under the Canadian medical device regulations.
Canada has one of the best regulatory systems in the world that make sure that medical devices sold in the country are safe, secure and effective. The Medical Device Regulations in Canada ensure that those companies that are engaged in manufacturing, labelling, packaging, and importing medical devices for sale are doing so in a compliant manner.
A Medical Device Establishment License (MDEL) is required to manufacture, import, or distribute medical devices in Canada.
Any company failing to meet Health Canada’s medical device regulations or providing misleading statements in the application will have their establishment license suspended.
Quality Smart Solutions helps clients comply with the Canadian medical device regulations by providing solutions for licensing, regulatory review and label compliance. We offer customized solutions for firms to establish a renowned medical device manufacturing facility.
Our compliance officers ensure your medical devices meet the Medical Devices Regulations and a license is issued so that your device is listed on Health Canada’s public website.
Get assistance from experts for manufacturing, distributing and importing medical devices. We help you meet ISO 13485 or 13488 standards to acquire a medical device establishment license (MDEL).
Our experts can help you sell In Vitro Diagnostic (IVD) devices in Canada by providing assistance in registering and obtaining a Medical Device License (MDL) from Health Canada.
Register your medical device software with Health Canada with the help of our experts. Our professionals can help you determine your device’s risk evaluation, inclusion and exclusion criteria.
We have licensed a wide range of medical devices, including but not limited:
Your medical device needs to be licensed prior to sale in Canada. Our team of experts can help license your Class II, III or IV medical device.
A Medical Device Establishment Licence (MDEL) is a licence issued to manufacturers of Class I medical devices as well as importers or distributors of all device classes. The MDEL permits businesses to import or distribute a medical device in Canada. An MDEL provides Health Canada assurance that medical devices sold or imported into Canada meet the safety requirements set out in the Medical Devices Regulations, and that procedures are in place to protect the public should a problem with a device be identified. The MDEL listing contains information about the licensed establishment including their company ID, licence number, company name, address, authorized activities and associated class of device(s).
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