Medical Devices Compliance

Health Canada strictly regulates the import of medical devices into Canada. Royal Canada Compliance Solutions provides agent service for obtaining Health Canada’s Medical Device Establishment Licensing (MDEL).

Health Canada's Medical Device Regulations

Discover how Health Canada's Medical Device regulations play a crucial role in safeguarding the import of medical devices into Canada. We provide expert agent services to assist you in obtaining Health Canada's Medical Device Establishment Licensing (MDEL).

Importing Medical Devices into Canada

Discover how our agent service can help you obtain Health Canada’s Medical Device Establishment Licensing (MDEL) for importing medical devices into Canada. Our team of experts will guide you through the regulatory requirements and ensure a smooth and efficient process.

Why Choose Our Agent Service?

Save time and resources by partnering with us for your medical device import needs. Our experienced team understands the complexities of Health Canada’s regulations and will handle all the necessary paperwork and communication with the authorities. Trust us to navigate the process smoothly and efficiently.

Royal Canada offers the following services to help prepare you for your MDEL or MDL registration

• Medical Device Classification

• Medical Device Licensing for class II, III and IV

• Establishment Licensing

• Private Label Licensing

• Label Review

• MDSAP implementation and certification assistance

Medical Device Classification

Medical devices are classified into one of Classes I to IV by means of the classification rules set out, where Class I represents the lowest risk and Class IV represents the highest risk. If a medical device can be classified into more than one class, the class representing the higher risk applies.

Medical Device License (MDL)

A medical device licence (MDL) is a licence that is required for companies that import, sell, or distribute Class II, III, or IV medical devices in Canada.

Medical Device Establishment License (MDEL)

A medical device establishment licence (MDEL) is a licence that is required for any company that imports, sells, or distributes any class of medical device in Canada.

Software as a Medical Device (SaMD)

Health Canada is responsible for helping Canadians maintain and improve their health. It ensures that high quality health services are accessible, and works to reduce health risks.

Software as a Medical Device (SaMD) - Classification

1. Non‐IVDD SaMD
   
   a. Class I SaMD
   
   
   b. Class II SaMD
   
   
   c. Class III SaMD
   
   

2. IVDD SaMD
   
   a. Class II IVDD SaMD
   
   
   b. Class III IVDD SaMD
   
   

3. Software that is not subject to the Regulations