Record ID 100528

Title
Medical devices - Software - Canada @ Software regulated as a class I or class II medical device - Record updated 2010-12-05
Source
[Health Canada]
Issued
2010-12-03
Record released
2010-05-23
Record updated
2010-12-05
Geographical area
Canada
Language
en
Sector
Healthcare
Normative state
Statutory or regulatory
Consumer versus non-consumer product
Non-consumer product
Publisher
Health Canada
Description

2010-12-03
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'
[Conforlex] link

 

Record type
Notice
Organization function
Design, development, documentation, Marketing, sales, Quality management, regulatory affairs,
Product part
Software
Keywords
Classification, Healthcare, Healthcare informatics, Medical device, Regulation, Software, Software, Statutory document

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