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(Thanks to Riz Kheraj from NRC-IRAP for sending this information - Ed)

On December 3, 2010, Health Canada issued a revised notice regarding Software Regulated as a Class I or Class II Medical Device.  Health Canada has also published the much-anticipated corresponding FAQ document to assist in clarification.

Software Regulated as a Class I or Class II Medical Device

The following FAQ document states that “ASPs (application service providers) do not fall within the scope of the Regulations since no sale of a medical device is taking place. If the software manufacturer has the software hosted by a third party on their behalf, this is also not considered to be a sale”. Health Canada has stated this publically.

Software Regulated as a Medical Device - Frequently Asked Questions

Please note that compliance deadlines (February 1, 2011 for Class I devices and September 1, 2011 for Class II devices) have not changed.

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Read More: http://blog.canadianemr.ca/canadianemr/2010/12/health-canada-update-software-medical-device.html