Health Canada Compliance: Medical Device Classification, MDL, and MDEL

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CanSummit consulting area(s) referenced in this case study: Comply with Health Canada Regulations

CanSummit consulting service(s) referenced in this case study: Medical device classification, Medical device licenses (MDLs), Medical Device Establishment Licenses (MDEL)

Medical device description: Multiple medical devices in a portfolio i.e. medical devices for diagnosing kidney infection in professional clinic and home settings in patients on Peritoneal dialysis and blood collection tubes for collecting blood specimens  

Medical device geographic region of origin: Europe

Business challenge/ Project objective: The medical device manufacturer and their Canadian distributor commissioned our services to develop and implement a comprehensive Health Canada regulatory compliance strategy for their devices. 

Our actions: We delivered and managed the entire project to develop and implement a ‘Health Canada Regulatory Compliance Solution’ for the clients. The key deliverables we produced for the client included the following:

  • Classification of the medical devices as per Health Canada regulations

  • Medical device license (MDL)

  • Medical device establishment license (MDEL)  

Project outcomes: Blood collection tubes were classified as Class I and did not require a MDL. The kidney infection test was classified as Class III and required a Class III MDL. The Canadian distributor required a MDEL. We managed the entire project and helped the medical device manufacturer and the Canadian distributor to obtain the required Health Canada licenses within the Health Canada performance target time frame. 

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Key takeaways: 

  • Sometimes MD&D manufacturers can assume that the Health Canada medical device classification and license requirements for their product(s) are similar to those in the USA or Western Europe. This can result in significant avoidable costs, delays, liability exposure, and business disruption.  

  • The fact is that Health Canada classifies and licenses medical devices independently of other jurisdictions. Therefore, it is crucial for MD&D manufacturers to accurately classify and license their medical devices specific to Health Canada rules and regulations. 

Important policy note: It is always our policy to protect our clients’ confidential information . Given the highly competitive nature of the MD&D market, our clients need us to keep their strategic project investments made with our firm as confidential . For this reason, we do not publish client identification information in our case studies. If required, we would be pleased to arrange for client references from this project for prospective clients, provided the prospective clients do not have a conflict of interest with this project’s client.    

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