Health Canada compliance for manufacturers of Electronic Medical Record (EMR) systems selling in Canada
On August 31, 2009, Health Canada issued a notice requiring all manufacturers of Electronic Medical Record (EMR), Electronic Health Records (EHR) and Patient Management Software (PMS) systems sold in Canada to register those products as Class I or Class II medical devices. The deadline for compliance is August 31, 2010.
The Health Canada notice states the following:
"...patient management software used only for archiving or viewing information or images, and not involved in the primary acquisition, manipulation and transfer of data, is considered a Class I medical device. Class I devices will require that manufacturers, distributors and importers obtain an establishment license. Patient management software involved in data manipulation, data analysis, data editing, image generation, recording of measurements, graphing, flagging of results or performing calculations is considered a Class II medical device, as is any primary workstation that interfaces directly with a system (imaging or other type) by acquiring data and then sending data to an image generating, viewing or storage device. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device license."
Based on this, the following is required of EMR, EHR and PMS system manufacturers:
EMR systems considered CLASS I medical devices by Health Canada
- Medical Device Establishment License (MDL)
EMR systems considered CLASS II medical devices by Health Canada
- Medical Device License (MDL)
- Audited quality management system that complies with ISO 13485:2003 and the Canadian Medical Device Regulations (CMDR)
EMR, EHR & PMS manufacturers must comply with the new Health Canada requirements by August 31, 2010. Emergo Group can help.
Emergo Group specializes in helping medical device companies comply with global medical device regulations, including those imposed by Health Canada. Our team of consultants can help you submit a Medical Device Establishment License (MDEL) or a Medical Device License (MDL) for your EMR system.
Implementing ISO 13485:2003 or upgrading an existing ISO or FDA GMP compliant quality system.
Medical device companies with Class II or higher devices must comply with ISO 13485:2003 and the specific requirements of the Canadian Medical Devices Regulations (CMDR). Health Canada does not recognize US FDA GMP so if you are not ISO 13485:2003 certified, you must also implement this quality system standard and be audited by a Registrar that has been accredited to the Canadian Medical Devices Conformity Assessment System (CMDCAS). Read more about how we can help you obtain ISO 13485 certification.
Please contact us for a free proposal or more information on meeting the Canadian regulatory requirements for EMR/EHR/PMS systems.
