Talk to an expert now to know about Canada medical device classification. Get an In Vitro Diagnostic (IVD) Medical Device License (MDL) from Health Canada and we can also assist you in getting 510(k) submissions for IVD devices in the US. Learn more about Medical Devices Qualification in Canada and get your device regsitered quickly with Arora Consultancy.
Medical device compliance's most dependable consulting partner! To ensure that your devices comply with Health Canada's medical device rules, seek assistance from former Health Canada specialists. Medical devices are governed by Health Canada to guarantee their quality, efficacy, and safety. Learn about additional Medical Device requirements for Registration and selling or commercially importing a medical device in Canada as well as how Medical Device Regulations are created and updated.
A 15 calendar day review time objective is set for class II medical equipment.
A 75 calendar day review time objective is set for class II medical equipment.
A 90 calendar day review time objective is set for class II medical equipment.
We have expertise working with thousands of medical device startups in Canada. We'll support you.
We have expertise working with thousands of medical device startups in Canada. We'll support you.
Companies must submit an application for registration of medical device that contains basic information about their company and device, as well as any necessary supporting documentation, in order to register a medical device with Health Canada in compliance with the relevant Medical Device Regulations Canada. Depending on the risk class given to the medical device, all registration criteria must be fulfilled, which can include further assessments or testing. Before their items may be registered, businesses must also give an accurate description of their devices and pertinent studies demonstrating conformity with current legislation.
Health Canada has established a classification system based on the risk associated with the medical device. The classification depends on factors such as the intended use, duration of contact with the body, and potential harm to the patient.
Regulatory consultancy firms, such as Arora 297 Consultancy, specialize in navigating the complex landscape of Medical Device regulation. They provide guidance on regulatory requirements, assist with licensing and registration processes, and ensure compliance with Health Canada's regulations and guidelines.
The process for obtaining a Medical Device License (MDL) in Canada involves submitting an application to Health Canada, providing detailed information about the device, its intended use, and supporting documentation such as clinical data, safety testing results, and quality management system certification.
The Medical Device Establishment License (MDEL) is a license issued by Health Canada that allows a company or organization to import, distribute, or sell medical devices in Canada.
Health Canada defines a Medical Device as any instrument, apparatus, machine, or other similar article that is used to diagnose, treat, or prevent a disease or a medical condition.