Note: Exact text provided by Health Canada
ASPs (application service providers) do not fall within the scope of the Regulations since no sale of a medical device is taking place. However, if the ASP has purchased a medical device with which the ASP is providing a service, the manufacturer of the device is still required to comply with the requirements of the Medical Devices Regulations and obtain the appropriate licence prior to the sale to the ASP.
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Is Health Canada making a distinction between a device being purchased vs. a service being acquired. This seems odd that thee device regulations should be based on how the device/product/service is sold - not on functionality. What would be the difference if someone rented a machine vs. owning a machine?
ReplyDeleteNice post.
ReplyDeleteThe intended effect of EMR systems on the healthcare landscape is wide-ranged depending on the type of system and the environment in which it is being implemented.
derric