for your information
Health Canada’s authorization
needed for custom-made devices
72
Dialogue Issue 2, 2015
(a) s manufactured in accordance with a health care
i
professional’s written direction giving its design
characteristics;
(b) iffers from medical devices generally available for
d
sale or from a dispenser; and
(c) is
(i) or the sole use of a particular patient of that
f
professional, or
(ii) or use by that professional to meet special
f
needs arising in the course of his or her
practice.
Health Canada brought this to the attention of the
College because of concerns that this practice may be
occurring at the order of other physicians as well.
The Regulations are available from the Department
of Justice website at: http:l/laws-lois.justice.gc.ca/eng/
regulations.
Health Canada guidance documents, including the
Application Form for Custom-Made Devices and
Medical Devices for Special Access, are available at:
http://www.hc-sc.gc.ca/dhp-mps/acces/md-im/
index-eng.php
photo: istockphoto.com/michaeljung
H
ealth Canada is investigating a complaint
alleging the preparation and sale of a
hyaluronic acid (HA) dermal filler by
an accredited Ontario pharmacy without authorization from Health Canada. This event is
alleged to have occurred following an order from an
Ontario-licensed physician for an office supply.
Physicians are reminded that sale of a custom-made
medical device without authorization from Health
Canada is against its regulations. If physicians wish to
obtain a custom-made device for a patient, it is their
responsibility to apply to Health Canada for an authorization that would permit the manufacturer, in this case
the pharmacy, to sell the device to that professional.
HA dermal fillers are regulated as Class III medical
devices under the Medical Devices Regulations. Examples of manufactured products, which are licensed
by Health Canada, include Restylane and Juvederm. A
compounded product, such as the one described in the
complaint, is considered a “custom-made device”, and
is defined in the regulations:
“custom-made device “means a medical device, other
than a mass-produced medical device, that