Medical Device Licence

Understanding MDSAP and Its Role in Canadian Market Access

Oct

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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

Understanding MDSAP and Its Role in Canadian Market Access

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

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…