MDL Canada

Understanding MDSAP and Its Role in Canadian Market Access

30

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…

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Contraceptive Device Licensing in Canada: A Quick Overview

08

Jul

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Medical Devicescontraceptive device classification, contraceptive labelling Canada, contraceptive medical devices, contraceptive product compliance, Health Canada medical device licensing, ISO 13485 compliance, IUD licensing Canada, MDEL Canada, MDL Canada, medical device application Canada, medical device regulations Canada, post-market surveillance Canada, regulatory affairs Canada, SNI regulatory support

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…

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