Open Dental is CCDWS, CDAnet, CDHAnet(TM) certified/approved and ready for use in all Canadian dental and hygiene offices.
To see the Canadian features, set the Region and Language on each workstation to English (Canada) or French (Canada) before opening Open Dental.
Procedures and Claims
Per Health Canada, Open Dental Software does not need to be classified as a Medical Device as we meet the exclusion criteria below.
The following information can be found in detail here: Draft Guidance Document - Software as a Medical Device (SaMD)
2.2 Exclusion criteria
The medical purposes described in the device definition of the Act can apply to a wide range of products. However, software that does not have a direct impact on the diagnosis, treatment, or management of an individual's disease, disorder, abnormal physical state or symptoms would not be subject to the Regulations (e.g. a mobile app intended to monitor daily calorie intake and energy expenditure to allow an individual to self-manage their weight).
It has been Health Canada's longstanding position that the following types of software do not meet the definition of a medical device and are therefore not subject to the Regulations:
Additional clarifying information can be found here: Software Regulated as a Medical Device - Frequently Asked Questions