Is patient management software developed in-house by health care organizations subject to the Medical Devices Regulations?

Medical devices developed and used exclusively in-house by healthcare providers do not fall within the scope of the Regulations as they do not meet Section 2 of the regulations:

2. These Regulations apply to
(a) the sale and advertising for sale of a medical device; and
(b) the importation of a medical device for sale or for use on individuals, other than importation for personal use.

[Note: This answer was reviewed by Health Canada]