According to Health Canada's revised position, unlicensed
devices may now be disclosed in a manufacturer's response to an
RFP provided that:
(a) A specific health
risk is not identified in connection with the unlicensed device;
(b) The following
conditions are clearly stated:
(i) The product
is not currently licensed for sale in Canada; and
(ii) 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
 As defined in the Food and Drugs Act, R.S.C.
1985, c.F-27, "Sell" is expanded to include "offer
for sale, expose for sale, have in possession for sale and
distribute, whether or not the distribution is made for
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Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
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