Medical Device Regulations
In Canada, manufacturers, importers, and distributors of Class I to Class IV medical devices must comply with Health Canada’s Medical Device Licence (MDL) and Medical Device Establishment Licence (MDEL) requirements, specific to their devices. Our team is here to assist with your site and product licence applications, from product classification to handling follow-up inquiries from the directorate on your behalf.
Medical Device Regulations
In Canada, medical devices are regulated by Health Canada under the Medical Devices Regulations, requiring classification from Class I (low risk) to Class IV (high risk), with higher-risk devices needing a Medical Device License (MDL) and Class I devices requiring a Medical Device Establishment License (MDEL).
Class II to Class IV devices licensed to foreign license holders must be imported into Canada under a Medical Device Establishment Licence (MDEL) held by a Canadian company. Compliance with ISO 13485 standards, post-market surveillance, and bilingual labelling is mandatory and regulated by the Medical Devices Directorate (MDD). The Medical Device Single Audit Program (MDSAP) simplifies this by allowing a single audit to meet the regulatory requirements of Canada and other participating countries, including the U.S., Australia, Japan, and Brazil, streamlining the process and ensuring global compliance.
HOW DELL TECH CAN HELP WITH
MEDICAL DEVICE REGULATIONS
Unlock the full potential of your medical devices with our expert licensing and compliance services. We specialize in guiding you through the Medical Device Licence (MDL) and Medical Device Establishment Licence (MDEL) application processes, ensuring seamless compliance with ISO 13485 standards under the MDSAP quality management system.
Our experienced team is committed to your success, providing tailored support for all your labelling and post-market surveillance needs. With our comprehensive expertise, you can confidently navigate the regulatory landscape and accelerate your market entry.
We support with:
- Medical Device Licensing
- Medical Establishment Licences
- Product Labelling and Translations
- Quality Management Systems
- Medical Device Single Audit Program (MDSAP)
- Medical Device Regulatory Strategic Planning
- Comprehensive medical device regulatory services for the US and EU, including assistance with 510(k) submissions, de novo classification, and other essential compliance pathways.
LEARN MORE ABOUT THE MEDICAL DEVICE REGULATIONS
FREQUENTLY ASKED QUESTIONS (FAQ)
What is the process for obtaining a Medical Device License (MDL) in Canada?
To secure a Medical Device License (MDL), you need to submit an application to Health Canada with detailed device information, clinical data, and evidence of compliance with Canadian regulations. Our experts can guide you through this process to ensure timely approval.
How are medical devices classified and what does this mean for licensing requirements?
Medical devices are classified from Class I (low risk) to Class IV (high risk). Higher-risk classes require more comprehensive documentation and clinical evidence. Understanding the classification is crucial for the medical device licensing process, and we can help you determine and meet the specific requirements for your device.
Is a Medical Device Establishment License (MDEL) necessary for Class I devices?
Yes, a Medical Device Establishment License (MDEL) is required for companies that are foreign manufacturers, or Canadian companies that import or distribute Class I devices in Canada, even though these devices do not need an MDL. We assist in obtaining MDELs to ensure compliance with Canadian regulations.
What are the labelling requirements for medical devices in Canada?
Labels for medical devices sold at retail must be in both English and French and include essential details such as the device name, intended use, warnings, and instructions. Devices used or issued by healthcare professionals must have bi-lingual labelling available immediately on request. Our services ensure your labels meet all regulatory requirements to avoid delays in medical device licensing.
Why is ISO 13485 important for medical device licensing?
ISO 13485 is a critical quality management standard for medical devices, ensuring that products meet safety and effectiveness regulations. Compliance with ISO 13485 is often required for obtaining a Medical Device License. We provide support to help you achieve and maintain this standard.
English