Health Canada Updates Requirements for Class II/III Infusion Pumps

Citing post-market safety concerns about the delivery accuracy of infusion pumps, Health Canada is updating the evidence requirements to demonstrate the accuracy of these devices through performance testing for new and amended license applications.

Effective immediately, new Class II and Class III license applications will require performance testing for:

• The pumping mechanism;
• Any software component that could affect fluid delivery accuracy; and
• A tubing set when the change impacts the delivery accuracy range stated in the pump labeling.

Devicemakers will need to include in their license applications performance testing data that “clearly demonstrates that the infusion pump can reliably deliver therapeutic agent within the accuracy ranges specified in product labeling,” the agency said.