Monday, August 16, 2010

Are application service providers (ASP) subject to the Medical Devices Regulations?

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.


  1. 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?

  2. Nice post.
    The 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.