Purchase of Licensed Medical Devices for Use in Healthcare Facilities and Requests for Proposal / Information (RFP / RFI) Processes

The following provides an update to Health Canada's letter to the Medical Devices community dated December 14th, 2009 and signed by Dr. Roland Rotter. This communication outlines Health Canada's position on Requests for Proposals and Information (RFP / RFI) activities and seeks to remind all stakeholders within Industry of their roles and responsibilities under the Medical Devices Regulations.

Key Considerations

Medical devices imported or purchased for use in health care facilities must comply with the Canadian Medical Devices Regulations (the Regulations). Class II, III or IV medical devices require authorization by Health Canada (by way of a device licence) before they can be legally imported and sold in Canada. In contrast to licensed devices, unlicensed devices have not undergone any assessment by Health Canada as to their safety, quality or effectiveness. Facilities that import and purchase unlicensed devices may place the health and safety of their staff and patients at risk.

Health Canada asks that all health care facility staff responsible for purchasing medical devices have relevant knowledge of the requirements of the  Medical Devices Regulations. Informing staff of regulatory requirements will help to assure that your health care facility complies with all applicable requirements.

In brief, Section 26 of the Regulations prohibits the importation and sale, including offering for sale of a Class II, III or IV medical device, unless the manufacturer of the device holds a medical device licence.

An exception to the above exists in the case of Class III or IV custom-made devices, medical devices for special access, and medical devices for the purpose of conducting investigational testing. Importation or sale under these circumstances is possible if the relevant sections of the Regulations are met and Health Canada has granted authorization.

In response to a request for clarification involving unlicensed medical devices and a manufacturer's response to a Request for Proposal or Information (RFPs or RFI) a review of this practice has been concluded. Health Canada now takes the position that a manufacturer's response to an RFP or RFI will not be considered as an "offer for sale" provided that a specific health risk is not identified and that the following conditions are clearly stated in the manufacturer's response to the RFP or RFI:

1. The product is not currently licensed for sale in Canada; and
2. The manufacturer may only sell the device after a licence for that device has been issued by Health Canada.

Before entering into any sale with a manufacturer, healthcare facilities must verify that the medical device is licensed by Health Canada.

More information

• Medical Devices Active Licence Listing (MDALL): information on licensed devices, including a licence history archive containing devices that were previously licensed for sale and are no longer active
• Medical Devices: information on the importation, sale, advertising, and licensing requirements of the Medical Devices Regulations

Questions

If a healthcare facility has a question or concern regarding the licensing status of a medical device they should contact the Medical Devices Bureau at (613) 957-7285. In Canada, you can contact the Inspectorate by phoning: 1-800-267-9675 / 613-946-5095 if your question involves a compliance and enforcement issue.