Medical Devices - SNI Inc.

02

Sep

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What You Need to Know About Health Canada’s Medical Device Classifications and Licensing

Whether you are an established medical device manufacturer or entering the Canadian market for the first time, determining the correct classification is the essential first step in licensing your product. An incorrect classification can lead to costly errors, regulatory delays, and extended time to market, ultimately resulting in lost revenue.…

28

Aug

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Selling Red-Light Therapy Devices in Canada: A Simple Guide to Compliance

Red light therapy devices have become increasingly popular for skin health, from cosmetic uses to therapeutic applications. As demand for non-invasive skin treatments grows, so does the need for regulatory clarity. While these products are often marketed as cosmetic or wellness tools, many fall under Health Canada's definition of a…

31

Jul

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Avoid Delays: How to Successfully License a Medical Device in Canada

When entering the Canadian market, medical device manufacturers face a complex regulatory system designed to safeguard patient safety and public health. Central to this framework is the classification of devices into classes I to IV, based on risk. This walk-through explains how Health Canada’s regulatory environment works, outlines each device…

Regulatory Framework for Licensing Contraceptive Medical Devices in Canada

15

Jul

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Medical Devicesbilingual labelling, Class II devices, Class III devices, clinical evidence, contraceptive medical devices, health canada, ISO 13485, Medical Device Licence, post-market surveillance

Regulatory Framework for Licensing Contraceptive Medical Devices in Canada

The licensing pathway for contraceptive products in Canada can be complex, particularly for manufacturers and importers aiming to introduce new products or expand existing lines. One of the main challenges is the lack of clear, consolidated guidance that explains how different types of contraceptives are regulated under Canadian law. Hormonal…

Contraceptive Device Licensing in Canada: A Quick Overview

08

Jul

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Contraceptive Device Licensing in Canada: A Quick Overview

The process of bringing contraceptive medical devices to the Canadian market involves navigating a clearly defined but often complex regulatory framework. Products such as intrauterine devices (IUDs), diaphragms, condoms, and contraceptive sponges are considered medical devices and are regulated by Health Canada under the Medical Devices Regulations. This overview outlines…