Canada has one of the world's most stringent regulatory systems for medical devices. This regulatory framework is governed by strict guidelines that every medical device manufacturer must meet if they wish to market their product in Canada.
Health Canada, through the Health Products and Food Branch, Therapeutic Products Directorate, and Medical Devices Bureau, oversees the regulation of all medical devices.
Devices are rigorously reviewed to ensure that they are safe to use. These regulations also ensure the effectiveness and quality of the medical device before it reaches the market under the Canada Medical Device Regulation (SOR/98-282), which has been in effect since 1998.
At Elexes, we have a team of experts who specialize in helping medical device manufacturers and companies meet Health Canada's registration guidelines, ensuring seamless compliance and successful market access.
Checklist for medical device manufacturers to comply with Health Canada Regulations:
⦿ Regulatory authority: Health Canada
⦿ Regulation: Medical Device Regulations (SOR/98-282)
⦿ Authorized Representative: Not required
⦿ QMS Requirements: ISO 13485 and MDSAP
⦿ Assessment of Technical Data: Health Canada
⦿ License Validity: Unlimited
⦿ Labeling Requirements: Party 21 of MDR (SOR/98-282)
⦿ Submission Process: Offline / Paper
⦿ Languages: English & French
Canada’s medical device classification system draws heavily from the EU’s Council Directive 93/42/EEC, sharing many rules and term interpretations.
However, a device’s classification in the EU does not guarantee the same classification under Canada’s system.
Manufacturers must carefully follow the classification rules outlined in the Canada Medical Device Regulations to determine the appropriate class for their devices.
The medical device classification by Health Canada is based on risk indicators such as:
⦿ Degree of Invasiveness
⦿ Duration of Contact
⦿ Body System Affected
⦿ Local vs. Systemic Effects
We have experts who can assist you when it comes to classifying medical devices under Health Canada’s regulations.
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
Health Canada issues the Medical Device Establishment Licence (MDEL) to regulate medical devices in Canada. The MDEL ensures devices meet safety standards under MDR SOR/98-282, and establishments comply with requirements for record-keeping, complaint handling, recalls, incident reporting, and timely updates to Health Canada. At Elexes, we have experts who can help medical device manufacturers navigate through the complex process of MDEL.
A medical device importer in Canada is responsible for bringing devices into the country for sale. Every importer must ensure the devices comply with Canadian regulations and are registered with Health Canada before distribution in the Canadian market. We help them comply with all the necessary regulatory requirements, ensuring the whole process runs smoothly.
A Medical Device Licence (MDL) issued by Health Canada authorizes manufacturers to import or sell Class II, III, or IV medical devices in Canada. It confirms compliance with the Medical Devices Regulations' safety, quality, and efficacy standards. This is where Elexes jumps in. We assist medical device manufacturers to comply with all the regulatory requirements, bringing your product to the market.
We assist you in getting accurate device classification and grouping as per Canadian regulations.
Comprehensive support for regulatory submissions in Canada.
Expert guidance for effective Health Canada interactions.
Assistance with the Medical Device Single Audit Program for Canada.
Identification and qualification of distributors to meet Health Canada requirements.
Licensing support for compliant market entry.
Streamlined process for Class II, III, and IV devices.
Support for managing regulatory changes post-approval.
Labeling services aligned with Health Canada standards.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
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Owner Liz Inc., Arizona
CEO Radformation, New York
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