Medical Device Regulations
In Canada, manufacturers, importers and distributors of Class I and Class II Medical Devices must obtain a Medical Device Establishment License (MDEL) from Health Canada. Our team will assist you with your site and product license applications, from product classification to fielding follow up questions from the directorate on your behalf.
Medical Device Regulations
In addition to obtaining an MDEL, Class II Medical Devices must have a valid Medical Device License to be imported or sold in Canada. Additional procedures are required to vetted including but not limited to storage, handling, installation, delivery and service.
HOW DELL TECH CAN HELP WITH MEDICAL DEVICE REGULATIONS
- Product Evaluation & Classification
- Label Review & Development
- Medical Device Establishment License Applications for Class I and Class II
- Medical Device License Applications for for Class II
- Quality Management System Support
- General Consulting on product claims
Jacqui Jenskey
Director of Regulatory Affairs
Call: 519.858.5021 ext 2028
Email: jjenskey@delltech.com
English