Health Canada’s Compliance Deadline Nears for Class I Device Software

Makers of Class I medical software must comply with Canada’s Medical Devices Regulations by Feb. 1. Class I software — intended to view images or other real-time data as an adjunct to the monitoring device itself — is exempt from the licensing requirements in Sections 26 through 43 of the Regulations. But manufacturers must make sure their software meets the remaining requirements, which focus on labeling, distribution records, problem reports, recall requirements, and safety and efficacy. Class II software must be in compliance by Sept. 1.
International Medical Device Regulatory Monitor