Health Canada reviews medical devices for safety, effectiveness, and quality before authorizing them for sale in Canada. Canada has a stringent medical device regulatory system, as it prioritises patient safety and effective healthcare delivery. If you are planning to sell medical devices in Canada, you will be required to register your product by securing a license. There are two types of licenses, medical device establishment licence (MDEL) or a medical device licence (MDL). The type of license required will depend on the device’s class. Navigating the Canadian medical device regulation system can be a tricky task. Hence, we prepared this guide to help you easily get Health Canada medical device registration.
What is the purpose of medical device regulation in Canada?
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. The purpose of the Canadian medical devices regulations is to help protect the health and ensure safety of Canadians using the medical devices. Thus, it is vital to get Health Canada medical device registration for launching your devices in Canada.
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. The classification of medical devices is as per the hazard/risk associated with a particular device. The medical device class will determine the type of license required. Risk indicators used to categorise the medical devices are degree of invasiveness, duration of contact, body system affected, and local versus systemic effects. Based on these risk parameters, 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 medical device registration system: An overview
To obtain the Health Canada medical device registration, you need to understand the Canadian medical device regulations. The class of medical device will determine the type of license required. Hence, for registering medical devices in Canada, the first step is to identify the device class. This will determine the applicable license, license application pathway, and necessary requirements. The two major license types are as follows:
- Class I medical devices require the medical device establishment licence (MDEL).
- Class II, III, and IV medical devices require the medical device licence (MDL).
We have presented in detail the regulatory pathway, license type, and requirements for each medical device class.
| Device Class | Risk | Regulatory Pathway | QMS Audit | Document Requirements |
|---|---|---|---|---|
| I | Low | MDEL | NA | MDEL application QMS procedures |
| II | Low-Moderate | MDL | MDSAP certificate | MDL application Fee form Labeling documents Declaration of Conformity (Doc) MDSAP certificate |
| III | High-Moderate | MDL | MDSAP certificate | MDL application Fee form Declaration of Conformity (Doc) ISO 13485:2016 certificate with MDSAP certificate Labeling Technical files as per IMRDF |
| IV | High | MDL | MDSAP certificate | MDL application Fee form Declaration of Conformity (Doc) ISO 13485:2016 certificate with MDSAP certificate Labeling Technical files as per IMRDF |
How to obtain Health Canada medical device registration? A step-by-step guide
- Determine the medical device class: Medical devices are categorised into Class I, II, III, and IV, based on risk level. The first and most important step in securing the Health Canada medical device registration is to determine the class to which your medical device belongs to. This will determine the license type and application pathway required.
- Apply for the right license type: MDEL is required for Class I devices. On the other hand, 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.
- Obtain required certifications: For MDL application, ISO 13485 certification under MDSAP is required. It is important to check the certificates required for your license type and secure them accordingly.
- Submit the application and pay the fees: Prepare the necessary documents and comply with guidelines applicable for the license. Additionally, pay the necessary fees. Submit the application to Health Canada.
- Application review and license grant: Health Canada regulatory officials will review the application and verify the documents. If all the criteria are satisfied, then the officials will grant the license.
Do foreign manufacturers need to hire an authorised representative?
Foreign manufacturers are not mandatorily required to appoint an authorized representative in Canada. Foreign manufacturers themselves may submit medical device registration applications and hold the Health Canada medical device registration.
7 Common medical device registration mistakes to avoid
- Failure to meet safety and effectiveness standards: Devices not complying with Health Canada’s safety and performance regulations will not be granted the license.
- Incomplete documentation: Incomplete documents, missing technical files, incorrect labelling details can all result in application rejection.
- Incorrect device classification: Incorrect medical device classification can lead to the wrong type of license application.
- Non-compliance with MDSAP requirements: Not complying with MDSAP requirements and not having ISO 13485 certification can lead to license application rejection.
- Delay in application fee payment: Delays in application fee payment can stall the application.
- Non-compliance with ongoing regulatory changes: Health Canada periodically updates its regulatory guidelines for medical devices. Failing to comply with the latest medical device regulatory guidelines can have negative repercussions.
- Poor post-market surveillance: Per license requirements, manufacturers must maintain records, report adverse events, and ensure ongoing compliance. Failing to comply with this guideline can lead to regulatory sanctions.
Email at [email protected] or call/Whatsapp on 9996859227 to easily obtain Health Canada medical device registration.
FAQs on Health Canada medical device registration
Can an FDA clearance fast track Health Canada medical device registration?
Notably, Health Canada does not consider medical device approvals in other countries as an advantage for device registration in Canada. It has its own regulatory framework and medical device manufacturers or importers have to secure the necessary license in Canada. However, most of the information required for Health Canada license application is the same as that of the EU technical file or US 510(k). Hence, having these documents prepared and approved could potentially reduce document preparation time. Notably, rejection of medical device license application in other jurisdictions may adversely affect license approval in Canada.
What is the difference between MDL and MDEL?
Medical device licence (MDL) and medical device establishment licence (MDEL) are the two major licenses issued by Health Canada.
The medical device licence (MDL) is issued to devices belonging to Classes II, III, and IV. Securing the MDSAP QMS certificate is a prerequisite for MDL application. On the other hand, medical device establishment licence (MDEL) is issued to devices belonging to Class I. Securing the MDSAP QMS certificate is not a mandatory requirement.
Is it possible for foreign manufacturers not having an MDEL to market their medical devices in Canada?
Yes, foreign manufacturers not having an MDEL can market Class I medical devices in Canada provided their importer/distributor has an MDEL.
What are the quality management system (QMS) requirements for medical device licence (MDL)?
For securing medical device licence (MDL), ISO 13485: 2016 quality management system (QMS) certification under medical device single audit program (MDSAP) is mandatory. Additionally, compliance with all MDSAP guidelines is required. Furthermore, the QMS should be at par with the standards outlined in the Canadian Medical Devices Regulations (CMDR).
How to inform Health Canada about changes in MDL?
Health Canada has to be notified about changes to existing Medical Device Licence (MDL). This can be done by submitting an amendment form along with a summary of the changes from the originally approved details.
