EMERGO SUMMARY OF KEY POINTS:

• Health Canada is establishing a new division for premarket review of digital health technologies.
• The new Digital Health Review Division will handle licensing of wireless medical devices, mobile medical apps and related digital health products.
• Health Canada plans to align its new division with similar digital health oversight initiatives by the US FDA and other regulators.

Medical device regulators at Health Canada are developing a more targeted oversight approach for digital health technologies such as mobile medical applications.

A new notice from Health Canada explains that the agency has formed a new division in its Medical Devices Bureau, the Digital Health Review Division, to focus on premarket reviews of digital health products taking into account these technologies’ faster development and innovation cycles compared to traditional devices.

The launch of the new division falls under Health Canada’s broader Regulatory Review of Drugs and Devices initiative to improve premarket review processes for healthcare products in the country.

Focus of the new Digital Health Review Division

Health Canada’s new division will utilize review staff with expertise on devices with significant digital health technology components, and implement a review process that aligns with similar approaches established by other medical device regulators such as the US FDA’s Digital Health Innovation Action Plan and Pre-Cert for Software program.

Specific areas the new Health Canada division will target include wireless medical devices and mobile medical apps, software as a medical device (SaMD), artificial intelligence, cybersecurity and device interoperability.

Related Canadian medical device regulatory resources:

• Health Canada Medical Device License (MDL) registration consulting
• CMDCAS, MDSAP and Health Canada ISO 13485 quality system compliance support