Health Canada notice
Software regulated as a class I or class II medical device
This notice clarifies what medical software is regulated as a Class I or Class II medical device, how the Schedule 1 Classification Rules are applied to software, and Health Canada's approach to bringing Class I and Class II medical device software products into compliance with the Regulations.
This notice applies to:
- Software that meets the definition of a medical device and is classified as a Class I or Class II device under the Schedule 1 Classification Rules.
- Note that the Regulations apply to Free and Open-Source (FOSS) device software, since the definition of "sell" in the Food and Drugs Act, includes transactions without compensation.
This notice does not apply to:
- Software related to in Vitro Diagnostic Device (IVDD), including those software systems that are used to control IVDDs or analyze results from IVDDs, i.e., software products classified via Part 2 of Schedule 1, Classification Rules in the Medical Devices Regulations.
The notice in question: [Health Canada] link
See related Conforlex records [Conforlex] link
Conforlex record 'Medical devices - Market access - Canada @ Statutory and regulatory requirements and related documents'