Medical Device Licence

20 Aug 2026

SNI Presentation: Selling Red-Light Therapy Devices in Canada

Canadian Medical Device Regulations, Medical DevicesCanadian Medical Device Regulations, Class II Medical Device, Device Classification, FDA Clearance, health canada, LED Light Therapy, MDEL, MDSAP, Medical Device Licence, Red Light Therapy Devices

Red-light therapy devices have become increasingly popular across the beauty, wellness, and dermatology markets. From LED face masks to handheld light therapy tools, these products are often positioned as non-invasive solutions for skin appearance, acne-prone skin, inflammation, and signs of aging.However, in Canada, the way a red-light therapy device is…

Understanding MDSAP and Its Role in Canadian Market Access

Medical DevicesFood and Drugs Act, health canada, ISO 13485, ISO 13485:2016, MDL Canada, MDSAP, MDSAP audit, MDSAP audit cycle, MDSAP audit process, MDSAP Canada, MDSAP certification, Medical Device Licence, Medical Device Single Audit Program, Medical Devices Regulations

The Medical Device Single Audit Program (MDSAP), developed by the International Medical Device Regulators Forum (IMDRF), is a harmonized audit framework that allows a single ISO 13485:2016 audit, conducted by an approved Auditing Organization (AO), to meet the quality management system (QMS) requirements of multiple regulatory authorities simultaneously. In Canada, MDSAP serves as the recognized mechanism…

Regulatory Framework for Licensing Contraceptive Medical Devices in Canada

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

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…