This blog is one of many in a series of blogs in which general regulatory requirements and the most recent regulatory developments in the biggest global medical device jurisdictions will be covered. In this blog, the jurisdiction of attention is Canada.
General Information In Canada, Health Canada (HC) is the authority responsible for medical device safety & quality control, and vigilance. Health Canada regulates medical devices under the Food and Drugs Act and the Medical Devices Regulations (SOR/98-282). The regulation process ensures that medical devices sold in Canada are safe, effective and of high quality.
All medical devices are classified following a risk-based approach comparable with the classification systems of the European Union and the FDA. The range spans from Class I, II, III, and IV, where Class I is low risk and Class IV is high risk.
To sell a medical device in Canada, the manufacturer of the medical device must obtain a medical device license. Depending on the risk classification of the medical device, a certain type of medical device license is required:
- For Class I medical device, a Medical Device Establishment License (MDEL) must be obtained by the manufacturer.
Class I medical devices are not required to have a certified quality management system. If all devices in the scope of certification are class I or if the audited facility’s contribution to the scope of certification only applies to class I medical devices, the audit at that facility may disregard the requirements of the Canadian regulation.
This type of license is also required for importers and distributors of all medical device risk classes.
- For Class II, III, and IV medical devices the manufacturer must obtain a Medical Device License (MDL).
The requirements for obtaining an MDL include providing evidence that the medical device meets the safety, effectiveness and quality requirements of Health Canada and is in compliance with the ISO 13485 quality management system under the Medical Device Single Audit Program (MDSAP).
Where in many countries/jurisdictions around the world a local representative is required in the country where the manufacturer wishes to place their device on the market if the manufacturer has no physical/legal presence, this is not applicable to Canada. Health Canada does not require foreign manufacturers to have local representation in order to register and sell medical devices in Canada. Foreign manufacturers can submit applications and hold device registrations without needing an in-country representative.
Registration process
Health Canada has dedicated forms available for the application of a MDEL or MDL licenses, but keep in mind that the MDL application forms differ per risk classification. In general, these MDEL and MDL application forms request information about the manufacturer, device name and intended use, license type, place of use, applied international standards, device history, and device identifiers.
The first step in the registration process is to determine the risk classification. As mentioned before, this also determines what type of medical device license is required. Based on the risk classification, the appropriate medical device license form and corresponding technical documentation can be prepared. When preparing the submission folder, make sure to adhere to the electronic submission requirements set out by Health Canada. This entails organizing the submission dossier to the prescribed folder and naming structure which follows the IMDRF approach. Following these instructions is key for a seamless submission process, dossier review and processing of the submission.
MDSAP
The Medical Device Single Audit Program (MDSAP) and Quality Management System (QMS) requirements are crucial for medical device registration in Canada. Since 2019, MDSAP is mandatory for all manufacturers of Class II, III, and IV medical devices in Canada. The MDSAP program replaced the Canadian Medical Devices Conformity Assessment System (CMDCAS).
The MDSAP program is designed to allow a single audit of a medical device manufacturer's QMS to satisfy the regulatory requirements of multiple jurisdictions, including Canada (Health Canada), the United States (FDA), Australia (TGA), Brazil (ANVISA), and Japan (MHLW/PMDA). In that sense, the MDSAP program streamlines compliance efforts by harmonizing regulatory requirements across participating countries, reducing the burden of multiple audits. The MDSAP audit follows a three-year cycle, starting with an initial audit, followed by two years of annual surveillance audits, and a recertification audit in the third year.
In summary, the MDSAP and ISO 13485 form the backbone of the regulatory framework for medical devices in Canada, ensuring that devices meet stringent quality and safety standards before they are marketed. Compliance with these requirements is essential for manufacturers aiming to enter the Canadian market.
Registration Validity
In Canada, both Medical Device Establishment Licenses (MDEL) and Medical Device License (MDL) have specific renewal requirements, effectively giving them an annual renewal cycle.
- Medical Device Establishment License (MDEL): This license must be renewed annually. The renewal process involves submitting an Annual Review application and paying the relevant fees by April 1 each year. Failure to do so can result in the cancellation of the license.
- Medical Device License (MDL): For Class II, III, and IV medical devices, the renewal process involves declaring the number of devices sold and paying a maintenance fee by November 1 each year. This ensures the license remains valid.
Therefore, while these licenses do not have an explicit expiry date, they require annual renewal to remain valid.
Latest regulatory developments
- Machine Learning-Enabled Medical Devices: Health Canada has developed pre-market guidance for machine learning-enabled medical devices. This guidance addresses the balance between emerging risks associated with AI-driven medical devices and the impracticality of repeatedly re-evaluating such products for post-market modifications. It includes predetermined change control plans and emphasizes Good Machine Learning Practices (GMLP)
- Updates to Recognized Standards: Health Canada has proposed updates to the guidance on recognized standards for medical devices. Stakeholders are invited to share their views on these updates, which aim to ensure that Canadian regulations remain aligned with international standards Regulatory Changes for Recalls: Health Canada is proposing to eliminate the mandatory reporting of Type III recalls, which involve products unlikely to cause adverse health consequences. This change aligns with international standards and aims to streamline the reporting process, allowing Health Canada to focus on more critical recalls that pose substantial risks to public health
Concluding remarks
In conclusion, Canada's regulatory landscape for medical devices is rigorous, ensuring that products are safe, effective, and of high quality. Health Canada oversees this process, requiring manufacturers to obtain appropriate licenses based on risk classifications. The MDSAP program, integral to Canada's system, harmonizes compliance across multiple jurisdictions, further streamlining the process. Recent developments, including guidelines for machine learning-enabled devices and updates to recognized standards, highlight Health Canada's commitment to staying aligned with global practices. Regular renewals of licenses are essential, underscoring the dynamic nature of regulatory compliance in Canada's medical device market.