Note: Exact text provided by Health Canada.
For the purposes of this document, “legacy system” is defined as follows:
“legacy system” is software that was designed, sold and deployed prior to February 1, 2011 (Class I) or September 1, 2011 (Class II).
The Medical Devices Regulations prohibit the sale of a Class II, III or IV medical device unless the manufacturer of the device holds a device licence in respect of it. However, as legacy systems have been previously sold without immediate risks to public health having been identified, they have not been prioritized for compliance with this prohibition until September 1, 2011. After that date the sale of a legacy system that is a Class II, III or IV device without a licence will be prioritized for compliance as any other device (according to Policy 001 of the Health Product and Food Branch Inspectorate).
An establishment that imports or sells any medical device must also hold an Establishment Licence (“EL”) to do so. Compliance with that requirement has similarly not been prioritized until February 1, 2011. After that date the import or sale of a legacy system device without an EL will be prioritized for compliance as any other similar device (according to Policy 001 of the Health Product and Food Branch Inspectorate).
Neither servicing, maintenance nor use of a device is governed by these Regulations. Upgrading to a new version of the software, if the functionality, intended uses, or nomenclature of the system is altered, would be a “sale” of a medical device, and the new version would need to be licensed.