Health Canada, the Canadian national regulating authority responsible for the regulation of the healthcare sector, announced the creation of the Medical Device Directorate (MDD). According to the announcement, the creation of a new agency is necessary due to the increasing number of regulatory issues in the sphere of medical device regulations.
The activity of a new Directorate would be based on the life cycle approach, the practice utilized by national medical device regulating authorities of other countries. For example, a similar approach is currently used by the Center for Devices and Radiological Health (CDRH), a special body in the structure of the Food and Drugs Administration, the United States’ federal regulating authority. CDRH implements TPLC–total product life cycle approach based on the same principles. According to the life cycle approach, regulating authority performs its functions not only at the registration or initial assessment stage but during the whole lifecycle of a medical device, including post-marketing surveillance. Due to the implementation of this principle, a new Directorate would cover both pre-marketing functions previously carried out by the Therapeutic Products Directorate and post-marketing functions previously carried out by the Marketed Health Products Directorate.
Therapeutic Products Directorate (TPD) is an authority responsible for the pre-marketing assessment of all medical devices before placing them in the market. The authority analysis the data confirming the safety, effectiveness, and performance of medical devices in the course of marketing submission review. The TPD reviews Investigational Testing Authorization (ITA) applications on medical devices to check compliance with applicable regulations related to the way studies should be performed providing the minimization of risk study participants have to be exposed to. The TDA also performs general risk assessments regarding medical devices.
Marketed Health Products Directorate (MHPD) is an authority responsible for monitoring the safety and effectiveness of all medical products present on the Canadian market, including medical devices. The functions of the MHPD include the collection, processing, and analysis of adverse events reports related to medical devices, and publication of notices on important issues associated with the use of medical products and risk associated with them. The MHPD also performs risk assessment regarding the devices already placed at the market, informs all parties involved on the associated risk and collaborates with foreign national regulating authorities and international organizations to establish and maintain the information exchange.
The Directorate would also implement the following principles:
- Improvement and development of scientific capacities;
- Improved response to the innovative cycles;
- Improvement of transparency and access to the information in general;
- Increasing the quality of the services offered;
- Improvement of communications with all parties engaged in processes related to design, manufacturing, and marketing medical devices.
Powers and Responsibilities
In accordance with the information provided into the announcement, the creation of the Medical Device Directorate is a response to the increase in regulating activity within the rapidly growing medical device market. The activity of a new Directorate would be focused, first of all, on the following spheres:
- Wider utilization of the Quality Management Systems;
- Implementation of the ISO 9001 standards;
- Improvements in post-marketing surveillance.
The Directorate will also take part in the development of new guidance and regulations related to medical devices together with the improvement of communications with all parties involved. It would also work closely with the Digital Health Review Division–a special body within the Medical Devices Bureau structure responsible for pre-marketing assessment of medical devices based on digital technologies created earlier in 2018. The activity of the Digital Health Review Division is focused on innovative technologies, wireless medical devices, software intended for medical purposes (SaMD). This unit also operates in the spheres of Artificial Intelligence utilization and cybersecurity.
The new Medical Device Directorate would constitute an internal body of Health Canada, being a part of the Health Products and Food Branch (HPFB). According to the information already available, the new structure would employ more than one and half hundred of specialists, and the current executive director of the Health Canada would be its director. The Directorate would connect medical device experts from various spheres, including pre-marketing evaluation, post-marketing surveillance, and policy developments.
The structure of the Directorate includes the following internal bodies:
- Director General`s Office responsible for scientific advice and appeals;
- Scientific Review 1, responsible for Investigational Testing Authorization, In Vitro Diagnostics and post-marketing surveillance;
- Scientific Review 2, responsible for particular spheres, such as cardiovascular or musculoskeletal, and also for the Digital Health;
- Licensing department, responsible for all regulatory issues, including the processing of Class II applications and screening of Class III/IV applications;
- Planning and operations sector, specializing in internal Quality Management Systems, reporting, and transparency. It is also responsible for the Medical Device Single Audit Program.
- Policy, stakeholder engagement and international sector, responsible for communications with stakeholders, national authorities and international organizations, including the collaboration with IMDRF, and also for the consultations and policy development.
Medical Device Single Audit Program (MDSAP) is a program established by the leading healthcare authorities together with the IMDRF to simplify the registration and approval procedures for the manufacturers interested in placing their devices to the several different national markets. In the course of MDSAP, a manufacturer could appoint an Auditing Organization that would perform medical device audits based on the requirements mutually acceptable by all regulating authorities – members of the MDSAP initiative. In other words, the reports of an audit performed by an authorized Auditing Organization could be used by the regulating authority instead of performing the audit itself. The set of requirements utilized by an Auditing Organization combines the requirements implemented by the national regulating authorities participating in the initiative and does not introduce any new requirements. Such an approach has numerous advantages, namely:
- Reduction of the number of audits and inspections to be held;
- The ability to choose a particular independent Auditing Organization that would be impartial and unbiased;
- Improvement of audit predictability;
- The possibility to use the manufacturer`s participation in MDSAP for marketing purposes as a confirmation of its confidence in the quality of the device; and other benefits.
Prior to the transition that took place on January 1, 2019, Health Canada has been participating in MDSAP Pilot for three years. Nowadays Health Canada allows medical device manufacturers to provide MDSAP certificates in order to submit new marketing applications or to maintain the already existing license for Class II, III, and IV medical devices. The appropriate provision is set forth in Section 32 of the Canadian Medical Devices Regulations.
Despite one of the most developed medical devices regulating systems in the world and one of the most stringent requirements, Health Canada makes new steps aimed at the improvement of all regulatory system`s components to ensure the effectiveness and reliability of medical device regulation.
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