In Nov. 2019, Health Canada announced the creation of a Medical Devices Directorate (MDD) in order to establish a life cycle approach to regulating medical technology sold on Canadian markets.
The MDD was conceived as a part of Health Canada’s Medical Device Action Plan that sought to improve regulation of medical devices after an investigation by the International Consortium of Investigative Journalists found patient harms that were linked to surgically implanted medical devices used worldwide.
Health Canada, the department of the Canadian government responsible for national health, previously siloed medical technology regulation between premarket research and development and post-market durability and functionality during usage. Health Canada merged the existing functions under Therapeutic Products Directorate (premarket regulations) and the Marketed Health Products Directorate (post-market regulations) to create the MDD.
Under the MDD, Health Canada will be better able to regulate medical technology during its entire life from the start of its development to the end of its use either by a patient or a health provider.
The MDD will have a budget of $15.85 million with 165 positions to supervise the quality of medical technology and its compliance with standards and regulations. The MDD will also be able to expand upon its existing Quality Management Systems and Digital Health Unit.
The MDD is similar to the US Food and Drug Administration’s (FDA) Office of Product Evaluation and Quality (OPEQ). According to the Regulatory Affairs Professionals Society (RAPS), OPEQ also sought to establish a life cycle approach to better link the regulation of the start and end of a medical device. It differs from the MDD in that it divided the regulation of medical technology into several large product categories rather than maintain a single office for every product.
Health Canada and the FDA also already differ in a variety of requirements for medical technology, mostly when it comes to classification, compliance with international standards set by the International Organization of Standardization (ISO), and reviewer discretion.
Canada divides its medical devices into four classes of risk level, with I being the lowest risk and IV being the highest. The US divides its medical devices into three classes, with III being the highest risk. Canada does not require its Class I devices to pay any medical device license application fees and requires its Class II, Class III, and Class IV devices to pay $315, $4,524, and $10,520 respectively.
The US requires all its classes to pay the same scale of fees, which vary anywhere from $2,175 to $322,147 depending on the application type.
Health Canada enforces the ISO 14155 clinical investigation standards as law across all its medical devices, while the FDA only recognizes ISO 14155 and uses its own CFR 21 clinical investigation standards instead.
Health Canada also uses policies similar to another set of ISO standards for reviewing approval for medical devices, while the FDA uses its own version. Canada also participates in the Medical Device Single Audit Program (MDSAP) which links several countries under one set of regulatory requirements for all companies, including Germany, Japan, Brazil, and Australia. The US is a member of the MDSAP but has declined to enforce company participation in MDSAP.
Companies seeking to develop and sell medical technology for both Canadian and U.S. markets will still need to meet both countries’ requirements, but will now find the process smoother in Canada with the creation of the MDD. Patients and providers, through the MDD and other policies developed through the Medical Device Action Plan, will be able to better rely on medical technology and receive more regulatory transparency for the whole life cycles of the products they use.
Originally published December 10, 2019
By Benjamin Duong
Benjamin Duong is a medical student and freelance writer based in Dothan, Alabama. He has a Masters of Public Health from the George Washington University and majored in microbiology and political science at the University of Florida. He has worked on advocacy for issues ranging from medical education to global maternal and infant mortality.