The medical device space in Canada will see a wave of regulatory changes, with modifications to post-market surveillance regulations and the creation of a new premarket review approach for digital health technologies proposed this week.
As part of a five-year initiative aimed at improving the regulatory review of drugs and devices, Health Canada released two notices of intent on Tuesday, including plans to establish a new division within the Therapeutic Products Directorate’s Medical Devices Bureau to create “a more targeted premarket review of digital health technologies” and keep pace with the “fast innovation cycles” in which they are “rapidly changing.”
Digital health tools can “improve access to healthcare information, facilitate more timely diagnoses and treatments, and improve access to care for patients at home, at healthcare facilities, as well as in rural and remote communities,” Health Canada said, adding that the new division will lead to “better alignment with other regulatory agencies and stakeholders.”
The division will be focused on seven areas within digital health – wireless medical devices, mobile medical apps, telemedicine, software as a medical devices (SaMD), artificial intelligence, cybersecurity and medical device interoperability, according to Health Canada.
The approach for digital health products in Canada echoes the US Food and Drug Administration’s (FDA) moves in the space under its Digital Health Innovation Action plan
. FDA’s Center for Devices and Radiological Health intends to have its Pre-Certification program for expediting product reviews available to all developers of these technologies by the end of the year
FDA and Health Canada, as well as regulatory bodies from eight other countries, are also members of the International Medical Devices Regulators Forum, through which a SaMD risk-based approach was established.
Meanwhile, Health Canada’s proposed changes for strengthening post-market surveillance and risk management of medical devices via greater oversight include providing the Minister of Health with additional authority to make certain requests, such as for analytical issue reports from manufacturers.
A manufacturer would also be required to provide the Minister with an annual report and the information used to prepare it, as well as to notify Health Canada of “any significant change in the safety of a medical device arising from the report,” among other requirements under the proposed changes.
“We envision that these changes would apply to Class II, III, and IV medical devices,” Health Canada said.
Notice: Health Canada’s Approach to Digital Health Technologies
Notice of intent: Strengthening the post-market surveillance and risk management of medical devices in Canada