[{"data":1,"prerenderedAt":163},["ShallowReactive",2],{"content-mda-mdla-en":3},{"id":4,"title":5,"body":6,"description":154,"extension":155,"meta":156,"navigation":158,"path":159,"seo":160,"stem":161,"__hash__":162},"content\u002Fmda-mdla\u002Fmda-mdla.en.md","Medical Device Licensing for Canada",{"type":7,"value":8,"toc":136},"minimark",[9,14,18,21,26,36,40,48,51,55,58,61,63,67,70,74,79,83,91,95,100,104,115,119,127,129,133],[10,11,13],"h2",{"id":12},"accessing-the-canadian-market","Accessing the Canadian Market",[15,16,17],"p",{},"To sell medical devices in Canada, manufacturers must comply with the Medical Devices Regulations (SOR\u002F98-282) under the Food and Drugs Act.",[15,19,20],{},"Regulatory requirements vary depending on device classification:",[22,23,25],"h3",{"id":24},"class-i-devices","Class I Devices",[27,28,29,33],"ul",{},[30,31,32],"li",{},"Require a Medical Device Establishment Licence (MDEL)",[30,34,35],{},"The MDEL must be held by the manufacturer, importer, or distributor",[22,37,39],{"id":38},"class-ii-iii-and-iv-devices","Class II, III, and IV Devices",[27,41,42,45],{},[30,43,44],{},"Require a Medical Device Licence (MDL) issued by Health Canada",[30,46,47],{},"Additionally require an MDEL for the establishment involved in importation or distribution",[49,50],"hr",{},[10,52,54],{"id":53},"quality-system-requirements","Quality System Requirements",[15,56,57],{},"All manufacturers and establishments must operate under a Quality Management System compliant with ISO 13485.",[15,59,60],{},"Certification under the Medical Device Single Audit Program (MDSAP) is strongly recommended and often required for higher-class devices.",[49,62],{},[10,64,66],{"id":65},"our-services","Our Services",[15,68,69],{},"ALTRION provides comprehensive regulatory support for market access and ongoing compliance in Canada:",[22,71,73],{"id":72},"regulatory-strategy","Regulatory Strategy",[27,75,76],{},[30,77,78],{},"Device classification and regulatory pathway definition",[22,80,82],{"id":81},"licensing-registration","Licensing & Registration",[27,84,85,88],{},[30,86,87],{},"Preparation and submission of MDL applications (Classes II, III, IV)",[30,89,90],{},"MDEL registration for manufacturers, distributors, and importers",[22,92,94],{"id":93},"quality-compliance","Quality & Compliance",[27,96,97],{},[30,98,99],{},"Alignment with ISO 13485 and MDSAP requirements",[22,101,103],{"id":102},"post-market-activities","Post-Market Activities",[27,105,106,109,112],{},[30,107,108],{},"License renewals",[30,110,111],{},"Post-market surveillance",[30,113,114],{},"Incident reporting",[22,116,118],{"id":117},"representation-coordination","Representation & Coordination",[27,120,121,124],{},[30,122,123],{},"Representation for non-Canadian manufacturers",[30,125,126],{},"Direct interface with Health Canada",[49,128],{},[10,130,132],{"id":131},"our-approach","Our Approach",[15,134,135],{},"We support manufacturers at every stage of the Canadian regulatory process — from initial classification and licensing to post-market compliance — ensuring a structured and efficient pathway to market entry.",{"title":137,"searchDepth":138,"depth":138,"links":139},"",2,[140,145,146,153],{"id":12,"depth":138,"text":13,"children":141},[142,144],{"id":24,"depth":143,"text":25},3,{"id":38,"depth":143,"text":39},{"id":53,"depth":138,"text":54},{"id":65,"depth":138,"text":66,"children":147},[148,149,150,151,152],{"id":72,"depth":143,"text":73},{"id":81,"depth":143,"text":82},{"id":93,"depth":143,"text":94},{"id":102,"depth":143,"text":103},{"id":117,"depth":143,"text":118},{"id":131,"depth":138,"text":132},"End-to-end support for Medical Device Licence (MDL), MDEL registration, and compliance with Health Canada regulations.","md",{"image":157},"\u002Fimages\u002Fcanada.jpg",true,"\u002Fmda-mdla\u002Fmda-mdla.en",{"title":5,"description":154},"mda-mdla\u002Fmda-mdla.en","0JOQ8mL0rsVY2PPmgtO2xXtBbFe_JALPNQO5XF4Vqm4",1775573784294]