Medical Device License (MDL) Introduction

Most medical devices must have a licence before they can be sold in Canada. Health Canada categorizes devices as Class I, II, III, or IV, based on the risks associated with their use, including the degree of invasiveness, duration of contact with the patient, energy transmission hazard, and consequences of device malfunction or failure.

Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer’s declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential for risk and are subject to in-depth regulatory scrutiny before licensing and sale. The cost-effectiveness of medical devices is not considered. Surgical procedures do not require Health Canada licensing.

Our MDL Services Include:

1) Determine the classification of your device in Canada, if unclear.

2) Determine the proper annual license fee payable to Health Canada.

3) Complete and file the Canadian Medical Device License application.

4) Develop, implement or modify your ISO 13485:2003 quality management system to meet the Canadian Medical Device Regulations (CMDR).