What is Canadian certification?
Canadian approval refers to obtaining regulatory authorization to market a medical device in Canada.
For Class II, III, and IV devices, this authorization takes the form of a Medical Device License (MDL), issued by Health Canada to the device manufacturer.
The approval process is based on a demonstration of compliance appropriate to the device’s class. The higher the risk class, the more extensive the technical, clinical, quality, and regulatory information required in the application.
What are the classes of medical devices in Canada?
Medical devices are classified into four risk classes, ranging from Class I, which corresponds to the lowest risk, to Class IV, which corresponds to the highest risk. Class II, III, and IV medical devices must be licensed—known as a Medical Device License (MDL)—before they can be imported or sold in Canada.
MDL and MDEL: Two Licenses to Distinguish Between
The Canadian regulatory framework distinguishes between two important concepts: the Medical Device License (MDL) and the Medical Device Establishment License (MDEL).
The MDL is the device license. It is issued to the manufacturer and applies to Class II, III, and IV medical devices. It authorizes the importation or sale of the device in question in Canada.
The MDEL is an establishment license. It applies in particular to importers and distributors of medical devices in Canada, as well as to certain manufacturers of Class I devices. Health Canada specifies that importers and distributors must generally hold an active MDEL to import or distribute medical devices of all classes in Canada, while manufacturers of Class II, III, or IV devices must hold an MDL to sell their own devices in Canada.
This distinction is important for properly structuring a strategy for entering the Canadian market, particularly when multiple players are involved in the distribution chain.
Quality Requirements and MDSAP
For Class II, III, and IV medical devices, the manufacturer’s quality system is a key requirement for market access in Canada.
Health Canada states that the transition to the Medical Device Single Audit Program (MDSAP) is complete and that all manufacturers holding medical device licenses in Canada are now participating in this program. The MDSAP enables Health Canada to strengthen its oversight of medical devices marketed in Canada and to ensure that they meet high quality standards.
For manufacturers wishing to market Class II, III, or IV devices in Canada, preparations for certification must therefore be aligned with the implementation or maintenance of a quality system that complies with the applicable requirements and is audited under the MDSAP.
Our Support
Isocèle Conseil assists manufacturers with the preparation, submission, and maintenance of their Canadian regulatory filings.
We can provide support starting from the earliest stages of the project or as part of an expansion into the Canadian market for a product already on the market in Europe, the United States, or other markets.
We can help you determine your product’s regulatory status, its risk class, and the applicable requirements in Canada.
This analysis helps confirm the market access pathway, identify the necessary licenses, and define the data required to prepare a submission that complies with Health Canada’s requirements.
We’ll help you develop a strategy tailored to your system and your organization.
This strategy may include:
- determining the need for CDM;
- identifying the responsibilities of the manufacturer, importer, and distributor;
- an analysis of the potential need for MDEL;
- Identifying quality and MDSAP requirements;
- an analysis of the discrepancies between an existing EC, FDA, or international submission and Canadian requirements;
- planning the necessary steps before submission.
When the device falls under Class II, III, or IV, we help you prepare for the requirements related to the quality system and MDSAP.
Our support may include:
- an analysis of the gaps between your existing quality system and the MDSAP requirements;
- the integration of Canadian requirements into your quality processes;
- preparation for the MDSAP audit;
- support in addressing discrepancies or nonconformities.
Our Comprehensive Support for MDSAP: MDSAP
The composition of the dossier must be tailored to the medical device class and Health Canada’s requirements. The expected content varies depending on the device’s risk level: the higher the class, the more detailed the technical, clinical, quality, and regulatory information that must be provided.
Isocèle Conseil assists you in preparing or reviewing your MDL application to ensure that it is complete, consistent, and in line with Health Canada’s requirements.
Our services may include, among other things:
- verification of administrative information: device name, class, identification number, manufacturer, manufacturing site;
- the rationale for the Canadian classification;
- a description of the device, its intended use, and its indications;
- a review of the standards applied;
- analysis of safety and efficacy data;
- a review of performance, validation, biocompatibility, sterilization, and shelf-life data, as applicable;
- verification of the labeling and instructions for use;
- consistency with data already available in other markets, particularly CE marking or FDA submissions;
- verification of the MDSAP certificate;
- preparing or reviewing responses to questions from Health Canada.
Before submitting the application to Health Canada, we can conduct a completeness review of the application to verify that all required elements are included, consistent, and properly organized.
When Health Canada raises questions during the review, we can assist you in analyzing the requests and preparing your responses.
Our services may include:
- a regulatory analysis of the questions received;
- identifying the documents or supporting evidence to be provided;
- drafting or reviewing responses;
- updating the file as needed;
- verifying overall consistency before transmission.
The goal is to provide clear, well-documented answers that are consistent with the original regulatory strategy.
Why seek guidance?
Obtaining Canadian approval requires a thorough understanding of Health Canada’s expectations, the requirements of the Medical Devices Regulations, and the interactions between product licensing, the quality system, and the distribution chain.
Specialized support helps to:
- ensure the device is properly classified;
- Identify the appropriate license: MDL, MDEL, or both, depending on the parties involved;
- put together an application package that meets Canadian requirements;
- make the most of data already available in other markets;
- anticipate MDSAP requirements;
- minimize inconsistencies between technical, quality, and labeling documents;
- Prepare for ongoing compliance after the license is granted.
Are you interested in marketing a medical device in Canada?
Isocèle Conseil assists you in defining your Canadian regulatory strategy, preparing your registration application, and incorporating Health Canada’s requirements into your quality system.
Whether your device is already CE-marked, already on the market in the United States, or still in development, we can help you develop an approach tailored to your device, its risk class, and your goals for entering the Canadian market.
Contact us to discuss your Canadian certification project.