Health Canada issues two types of licenses, medical device establishment licence (MDEL) and medical device licence (MDL). Medical devices are categorised into Class I, II, III, and IV, based on risk level. It is important to determine the class to which your medical device belongs to. This will determine the license type and application pathway required. Medical device establishment licence (MDEL) is required for Class I devices. On the other hand, medical device licence (MDL) is required for Class II, III, and IV devices. It is important to apply for the right license type based on your medical device class. In this blog, we have highlighted the major differences between Health Canada MDL and MDEL.
Health Canada medical device classification system
To secure the Health Canada medical device registration, you need to understand the Canadian medical device classification system. Health Canada has established a risk-based medical device classification system. Medical devices are broadly classified as follows:
- Class I: Low risk medical devices. Examples: Bandages, examination gloves, tongue depressors, thermometers, manual brushes, crutches, etc.
- Class II: Low to moderate risk medical devices. Examples: Contact lenses, infusion pumps, hearing aid, powered toothbrush, etc.
- Class III: Moderate to high-risk devices. Examples: Ventilators, orthopaedic implants, respirators, etc.
- Class IV: High-risk devices. Examples: Pacemakers, heart valves, artificial hearts, etc.
Health Canada MDL and MDEL
To understand the differences between Health Canada MDL and MDEL, we must understand each of the regulatory pathways and their individual requirements.
What is Health Canada MDL?
To legally sell or import Class II, III, or IV medical devices in Canada, you have to mandatorily secure the medical device licence (MDL) issued by Health Canada. Medical device manufacturers are required to mandatorily comply with the Canadian medical device regulations (MDR) to secure the MDL. The regulations are in place to ensure the highest quality, safe, and effective medical devices are available in the Canadian healthcare system. Moreover, having an MDL demonstrates compliance with strict regulatory guidelines and quality standards, thereby commitment to patient safety and improved outcome. Thus, medical device manufacturers are required to fulfil certain requirements to secure the Canada MDL. We have highlighted some of the requirements.
Regulations for Class II, III, or IV medical devices in Canada
- MDAP requirement: Securing the ISO 13485:2016 certificate under the Medical Device Single Audit Program (MDSAP) is a pre-requisite to apply for an MDL. This demonstrates compliance with the quality management system (QMS) requirements of Health Canada. Compliance with MDSAP ISO 13485:2016 certification requirements is mandatory for securing the Health Canada medical device licence (MDL).
- Labelling requirements: All Class II, III, and IV medical devices are required to comply with labelling requirements of the Canadian MDR. The labels should clearly provide essential information, such as the device name, intended use, manufacturer details, and any relevant warnings. The label should be clear for users to easily understand the intended use of the device.
- Private labeller requirement: The private labellers are permitted to apply for the MDL only after the original medical device manufacturer is granted the MDL. The MDL application form for the private labellers is different from that for the original medical device manufacturers.
- Form submission: The MDL application form has to be submitted to Health Canada.
What is Health Canada MDEL?
To legally market Class I medical devices in Canada, medical device establishment licence (MDEL) is required. Class I medical devices pose minimal potential risk to patients and users. These medical devices are subject to fewer regulatory controls as opposed to those belonging to higher-risk categories. However, Class I medical devices are required to comply with essential safety, effectiveness, and quality standards outlined in the regulations. Additionally, manufacturers may opt to partner with a licensed importer and list their device under the importer’s MDEL. This way manufacturers of Class I medical devices can avoid paying the MDEL application fees.
Regulations for Class I medical devices in Canada
- Labelling requirements: All Class I medical devices are required to comply with labelling requirements of the Canadian MDR. The labels should clearly provide all essential information. Additionally, the label should clearly indicate the intended use of the device.
- Quality Management System (QMS): A formal quality management system (QMS), such as medical device single audit program (MDSAP) certification, is not strictly mandatory for Class I devices. However, manufacturers are strongly encouraged to implement a robust QMS to ensure product safety and effectiveness.
- Proper documentation: Manufacturers are required to compile and maintain proper documentation evidencing the safety and effectiveness of their Class I devices. The information should include design specifications, risk assessments, and testing data.
- Incident reporting: Regulations for Class I medical devices require manufacturers or importers to proactively track any adverse events or defects that might arise during the device’s market use. They are required to report any incidents involving their devices to Health Canada as part of post-market surveillance.
Requirements for issuing Health Canada MDL and MDEL
What are the requirements for issuing an MDL?
To obtain the MDL, the manufacturers are required to comply with Medical Device Regulations (MDR) of Health Canada. The MDSAP certificate is an important pre-requisite to apply for an MDL. Notably, different application forms for Class II, III and IV devices are applicable. Private labelers can apply for MDL only after the original manufacturer has obtained an MDL.
What are the requirements for issuing an MDEL?
The requirements for securing the MDEL are less rigorous. The importers and distributors of Class I medical devices need to have written procedures for complaint handling and device recalls to secure the MDEL. The manufacturers of Class I medical devices may import their product without an MDEL. However, the importers and distributors need to mandatorily have a valid MDEL.
Major differences between Health Canada MDL and MDEL
We have highlighted the major differences in requirements between Health Canada MDL and MDEL in the following table.
| Risk | Device Class | QMS Audit | Regulatory Pathway | Document Requirements |
| Low | I | NA | MDEL | MDEL application QMS procedures |
| Low-Moderate | II | MDSAP certificate | MDL | MDL application Labeling documents Declaration of Conformity (Doc) MDSAP certificate |
| High-Moderate | III | MDSAP certificate | MDL | MDL application Declaration of Conformity (Doc) ISO 13485:2016 certificate with MDSAP certificate Labeling Technical files as per IMRDF |
| High | IV | MDSAP certificate | MDL | MDL application Declaration of Conformity (Doc) ISO 13485:2016 certificate with MDSAP certificate Labeling Technical files as per IMRDF |
Renewal of Health Canada MDL and MDEL
Both Health Canada MDL and MDEL have to be renewed. The MDEL has to be renewed before April 1st of every year. On the other hand, MDL has to be renewed before November 1st of every year. Notably, the application form for renewal of MDL is different from that of the original licence application.
Post-licensing requirements for Health Canada MDL and MDEL
Compliance with regulatory guidelines cannot be overlooked after the license is granted. Regulatory compliance is a continuous and consistent process. Regular internal audits and review of compliance level should be carried out to ensure readiness for Health Canada inspections. Furthermore, Health Canada periodically updates its regulations. Entities are required to be informed and updated. Moreover, their medical devices should comply with the latest regulations.
Pharmadocx Consultants: Your trusted Health Canada consultant
Medical devices have an indispensable role in the healthcare industry. They have a pivotal role in patient diagnosis, monitoring, and treatment. Hence, the healthcare delivered to the patient is considerably dependent on the effectiveness of the medical devices. Therefore, Health Canada strictly regulates all medical devices entering the Canadian healthcare system. Hence, you have to comply with all Health Canada medical device regulations. Thus, it is vital to secure your license for launching your devices in Canada. Choosing between Health Canada MDL and MDEL and understanding which one is appropriate for your device can be a tough task. Email at [email protected] or call/Whatsapp on 9996859227 to let us help you identify the appropriate regulatory pathway for your device.
