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<\/span><\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/div>Service Regulation in Canada<\/h2>\n
Canada, with its population of over 38 million and a well-established national healthcare system, offers excellent market opportunities for medical device manufacturers.<\/p>\n
To market your medical device in Canada, it is necessary to comply with the Medical Device Single Audit Program (MDSAP), which covers compliance with the Canadian Medical Device Regulations (CMDR) quality management system (QMS) requirements and obtaining the necessary approval from Health Canada<\/a>.<\/p>\n<\/div>
Health Canada Medical Device Licensing<\/h2>\n
In Canada, a Medical Device Establishment License (MDEL) is required for marketing Class I medical devices, and a Medical Device License (MDL) is required for Class II, III, or IV devices.<\/p>\n
If your intention is to distribute licensed medical devices in Canada, an MDEL will be required.<\/p>\n<\/div>
Health Canada’s Quality System Requirements for Medical Devices and ISO 13485<\/h2>\n
Health Canada mandates that Class II to IV medical device manufacturers comply with the ISO 13485<\/a> Quality Management System (QMS) requirements under the MDSAP, ensuring compliance with the CMDR.<\/p>\n
Prior to marketing your device in Canada, your compatible QMS must undergo an audit conducted by a Medical Device Single Audit Program (MDSAP)-accredited Auditing Organization (AO).<\/p>\n<\/div>
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