Medical Device Licensing – Software
Our member, The Hespro Group (of regulatory consultants) has informed us of the following changes to the licensing of patient management software.
Health Canada has recently posted a notice informing stakeholders that patient management software is now considered a medical device and therefore is subject to compulsory licensing. This notice impacts manufacturers, developers and vendors of health care software in Canada.
Patient management software can be categorized as a Class I or Class II device.
Any patient management software used only for storing, acquiring, transferring or viewing information or images is considered a Class I device. Although Class I devices do not require a medical device license, manufacturers, distributors and importers are required to obtain a medical device establishment license.
Patient management software involved in data manipulation, data analysis, data editing, image generating, determination of measurements, graphing, flagging of results, identifying regions of interest or performing calculations is considered a Class II medical device. Prior to selling a Class II device in Canada, manufacturers must obtain a medical device license.
Software Classification Examples
ITAC Health recently submitted a number of software scenarios to Health Canada to get a sense of what constitutes a Class I or Class II medical device.
Note: The following list is a guide only and does not represent any definitive rulings by Health Canada. Please consult with your own regulatory advisors.
[Companies wishing to clarify whether their software is a Class I or Class II device are invited to contact The Hespro Group at 1-888-840-3456. The Hespro Group can assist you in classifying your products and obtaining the proper certification and licensing that are required for you to sell your devices in Canada.]
1. Physician Software System - Scheduling and billing only, no manipulation or alteration of clinical data: Not a medical device
2. Physician Software System - Records and displays demographic and clinical data only with no manipulation or alteration of data: Class I
3. Physician Software System - Electronic Medical Record – contains decision support functions, manipulates and displays data in different formats: Class II
4. Physician Software System - Accesses and uses information and decision support functions provided by provincial or regional electronic health record systems: Class II
5. Electronic Health Record System - Custom developed by a health care organization or government health ministry (e.g. chronic disease registry, public health surveillance) for exclusive use by that health care organization or government health ministry: Not a medical device for sale or distribution
6. Electronic Health Record System - Custom developed by a health care organization or government health ministry (e.g. chronic disease registry, public health surveillance) and is given to, or sold to another health care organization or government health ministry: Class II
7. Electronic Health Record System - Custom developed by a health care organization or government health ministry (e.g. chronic disease registry, public health surveillance) where a private sector developer retains ownership of the end-product which is subsequently sold to another health care organization or government health ministry: Class II
8. Commercial Off-the-Shelf (COTS) Software - that is not health care specific but is used for clinical applications, or is integrated into a health information system (e.g. office automation software, email software, operating systems, database software, web portal software, etc.): Not a medical device
9. Custom developed middleware that is developed to facilitate communications between health information systems and is distributed to multiple health care organization or jurisdictions (e.g. translation of proprietary clinical codes or messages into standard formats such as HL7 or SNOWMED CT) – Class I (to be determined)
10. COTS middleware that is not healthcare specific but is used to facilitate communications between health information systems: Not a medical device
11. Security system software that is not healthcare specific but is used to control access to and use of health information systems (e.g. encryption software, authentication systems): Not a medical device
12. Hospital administrative and financial systems (e.g. materials management, general ledger, billing): Not a medical device
13. Hospital ADT (admissions, discharge and transfer) systems: Not a medical device
14. Hospital clinical management systems (e.g. pharmacy, lab, diagnostic imaging, computerized physician order entry): Class II (to be determined)
15. Consumer health platforms - software systems available to consumers and healthcare providers on the internet that allow consumers and healthcare providers to enter, view, graph and manipulate personal health information (e.g. Microsoft HealthVault, Google Health): Class II (to be determined)