On September 4, 2013, Health Canada announced that it has revised its position on the exclusion of information describing unlicensed medical devices in responses to RFPs from Canadian healthcare facilities.
According to Health Canada's revised position, unlicensed devices may now be disclosed in a manufacturer's response to an RFP provided that:
- A specific health risk is not identified in connection with the unlicensed device; and
The following conditions are clearly stated:
- The product is not currently licensed for sale in Canada; and
- The manufacturer may only sell the device after a license for that device has been issued by Health Canada.
This new position revises the position taken by Health Canada in a letter to Canadian Hospital Administrators on December 14, 2009, warning that the inclusion of an unlicensed device by a manufacturer in response to an RFP would be in contravention of the Canadian Medical Devices Regulations ("MDR"). Health Canada's prior position was based on Section 26 of the MDR, which prohibits the "offering for sale" of unlicensed Class II, III or IV medical devices. According to Health Canada, a response to an RFP was an "offering for sale" of a medical device that fell within this prohibition. This prior position has been the subject of controversy since the time that it was first expressed by Health Canada in 2009, as this approach restricted the presentation of purely informational or otherwise non-promotional details of a manufacturer's medical device products in development. Moreover, there was some suspicion in the industry that not all medical device manufacturers were observing Health Canada's interpretation of Section 26 of the MDR, such that those who were detailing unlicensed pipeline products in responses to RFPs were gaining an unfair advantage.
In effect, Health Canada's revised position means that the inclusion of unlicensed products in a response to an RFP will not be an "offering for sale" of that unlicensed device so long at the conditions set out above are fulfilled. This should be welcome news to manufacturers, and is a credit to Health Canada for revising a controversial position in response to industry feedback.