Anova Quality Systems Services Inc.

Assisting Organizations in Quality Improvement Since 1993

Licensing Medical Devices in Canada

Class I: Manufacturers, importers or distributors of a Class I medical device selling directly (not through distributor) need to secure a Medical Device Establishment License (MDEL). Form – 0292 is used for MDEL application.
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/licences/form/frm-0292-eng.pdf
Class II, III & IV: Manufacturers, importers or distributors of Class II, Class III and Class IV must secure a Medical Device License (MDL).
Certification of the quality management system to ISO 13485 and CMDCAS is required for all organizations seeking MDL for all medical devices sold in Canada.
To apply for Class II the following form must be submitted to HC:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/applic-demande/form/licapp_demhom_cla2-eng.pdf

For class III and IV the procedure is more complicated and must be addressed on a case by case situation, the scope of documentation is similar to 510k clearance.
Private Label: If you wish to private label a medical device you need to comply with HC regulations for Private Labelling:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/label_marque_pri-eng.pdf

Private label manufacturers must apply for and obtain a medical device licence (MDL) in order to sell their Class II, III or IV private label medical devices in Canada.

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