Regulatory Affairs

This is a specific page called "Regulatory Affairs". It has links from the front page. Image shows 2 guards outside some Canadian office in Ottawa.  The image of guards depicts some Regulatory Authority, hence the picture.
Ottawa, Canada

Medical devices are categorized into Class I (e.g., bandages, adhesive strips), Class II (e.g., hearing aids, syringes), Class III (e.g., hip implants, cochlear implants) and Class IV (e.g., pacemakers, heart valves), where Class I presents the lowest risk and Class IV the highest. All Class I medical devices that are sold in Canada require a Medical Device Establishment License (MDEL). Further, all importers and distributors of Class II, III and IV devices require a MDEL. For manufacturers that want to directly sell or import Class II, III or IV devices, Health Canada issues the Medical Device License (MDL) authorizing them to do so.

ISO 13485 is the quality management standard used for medical devices worldwide. Additionally, ISO has device specific standards based on the device type and its intended use. In 2018, manufacturers with an existing MDL (Class II, III and IV) and the ISO 13485 Quality Management System (QMS) were transitioned by Health Canada to the consortium led Medical Devices Single Audit Program (MDSAP) which was instituted to reduce the number of audits or inspections and to optimize the applicable time and resources.

SigmaCan can work with your organization to obtain the MDEL for your Class I devices. In other cases where, your company is involved in one or more stages of the life-cycle of a Class II, III or IV medical device, SigmaCan will coordinate the ISO 13485 QMS certification with a recognized MDSAP auditor. To complement this, our team will also work with you to ascertain the MDL application type based on the device, device family, group, intended use, clinical studies, investigations, labelling and other regulatory requirements before submission.

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