Canada
Royal dental Software 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 your computer to English Canadian or French Canadian before opening Royal dental Software.
Setup
Procedures and Claims
Other
The following copyright notice applies to Ontario users:
The ODA Suggested Fee Guide which is included in the Royal dental Software Software Inc. software and the copyright herein, is owned by the Ontario Dental Association and may be used solely in conjunction with the Royal dental Software software under licence from the Ontario Dental Association. The "ODA Suggested Fee Guide", "ODA Suggested Fee Guide for General Practitioners", "ODA Design" and "ODA" are trademarks of the Ontario Dental Association.
Software As a Medical Device (SaMD) (June 26, 2019)
Per Health Canada, Royal dental Software 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The following information can be found in detail here: Draft Guidance Document - Software as a Medical Device (SaMD)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