The Clarkson Group offers assistance to organizations seeking regulatory approval to sell, distribute or manufacture medical devices in Canada. Whether you need help understanding the Health Canada requirements, implementing ISO 13485 or managing the licensing process, The Clarkson Group can help.
Our team has significant experience in assessing medical devices, developing the required quality programs, and completing the application documentation including:
- Device Classification Assessments
- Health Canada Medical Device Establishment License
- Design, implementation and document management of the required quality processes
- License applications and renewals
- Health Canada Medical Device License (required for Class II, III, IV)
- ISO 13485 implementation foreign and domestic manufacturers
- 3rd party ISO audits
- License applications and renewals
- On-going document management if required
- Quality Management System design, implementation and document management
What is Health Canada?
Health Canada is the government department responsible for national health. It has a number of branches including “Health Products and Food” which is mandated to manage the health related risks and benefits of health products and food including monitoring and evaluating medical devices. This particular function is similar to that of the FDA in the United States.
What licenses are required to sell medical devices in Canada?
There are 2 types of medical device licenses issued by Health Canada. The type of license required depends on the risk classification of the product. Health Canada has 4 risk classes. For products falling into the Class I category (the lowest risk classification), companies must have a “Medical Devices Establishment License” (MDEL). For Classes II, III and IV, companies must obtain a “Medical Device License” (MDL).
What products are subject to Health Canada’s licensing requirements?
All medical devices being sold in Canada are subject to the Food and Drugs Act and its regulations. What does that mean? If you are selling medical/health products in Canada, your company probably needs either an MDEL or your product needs an MDL.
What about medical software?
In August 2009, Health Canada issued a notice that some types of software used in medical/clinical applications are now considered to be medical devices and are subject to compulsory licensing under the Food and Drug Act. The 2009 notice was recently updated. To be redirected to the Health Canada software notice dated May 21, 2010 click here.
Contact us for more information on how we can help ensure your products can be marketed and sold in Canada.
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