-
CMDR
Medical Devices
Regulations
SOR/98-282
Registration 7 May,
1998
FOOD AND DRUGS ACT
Medical Devices
Regulations
P.C. 1998-783 7 May, 1998
His Excellency
the Governor General in Council, on the
recommendation of the Minister
of
Health, pursuant to subsections 3(3), 30(1) and
37(1)a of the Food and Drugs Act,
here
by makes the annexed Medical
Devices Regulations.
a S.C. 1993, c. 34, s.
73
MEDICAL DEVICES REGULATIONS
INTERPRETATION
1. The definitions in this
section apply in these Regulations.
y
other than energy generated by the human body or
gravity. A medical device that
trans
mits or withdraws energy or a
substance to or from a patient without
substantially altering
the energy or
the substance is not an active device. (instrument
actif)
ion with another medical
device, is intended to supply information for the
purpose of dete
cting, monitoring or
treating a physiological condition, state of
health, illness or congenit
al
deformity. (instrument diagnostique
actif)
tion with another medical
device, is intended to support, modify, replace or
restore a biol
ogical function or
structure for the purpose of treating or
mitigating an illness or injury or
a
symptom of an illness or injury. (instrument
thé
rapeutique actif)
C),
the Health Industry Business Communications
Council (HIBCC) or the European Arti
cle
Number (EAN), assigned to a medical device by the
manufacturer. (code à
barres)
as a stoma. (orifice du
corps)
y arteries, cardiac veins,
coronary arteries, common carotid arteries,
cerebral arteries, bra
chiocephalic
artery, aorta, inferior and superior vena cava,
renal arteries, iliac arteries and
femoral arteries. (systè
me
cardiovasculaire central)
systè
me nerveux
central)
ice to sense, interpret and
treat a medical condition without human
intervention. (systè
me
à
boucle
fermé
e)
n of these, that
is assigned to a medical device by the
manufacturer and from which a hist
ory
of the manufacture, packaging, labelling and
distribution of a unit, lot or batch of the
device can be determined.
(numé
ro de
contr?
le)
e,
that
(a) is manufactured in accordance with
a health care professional's written direction
givin
g its design
characteristics;
(b) differs from medical
devices generally available for sale or from a
dispenser; and
(c) is
(i) for the sole use of a
particular patient of that professional,
or
(ii) for use by that professional to
meet special needs arising in the course of his or
her pr
actice. (instrument fait sur
mesure)
ty of a tooth or attached
only to the enamel or dentin of a tooth. It does
not include a surgi
cal or dental
instrument. (produit dentaire)
dures recommended for
achieving the optimum performance of the device,
and includes c
autions, warnings,
contra-indications and possible adverse effects.
(mode d'emploi)
entitled, by virtue of
their membership in that body, to manufacture or
adapt a medical de
vice in accordance
with a health care professional's written
directions in order to meet the
specific requirements of a patient.
(pré
parateur)
the prediction
of disease or vertical transmission risks, or
monitoring, diagnosis or progno
sis.
(test gé
né
tique)
atients. It includes a group
of such facilities that report to one common
management that
has responsibility for
the activities carried out in those facilities.
(é
tablissement de
santé
)
provide health
services in the province. (professionnel de la
santé
)
ar code that is
assigned to a medical device by the manufacturer
and that identifies it and
distinguishes it from similar devices.
(identificateur)
urface of the
eye or penetrate the body, either through a body
orifice or through the body
surface.
(instrument effractif)
in vitro for
the examination of specimens taken from the body.
(instrument diagnostique i
n vitro ou
IDIV)
r a trade-mark, design,
trade name or other name or mark owned or
controlled by the pers
on, and who is
responsible for designing, manufacturing,
assembling, processing, labellin
g,
packaging, refurbishing or modifying the device,
or for assigning to it a purpose,
wheth
er those tasks are performed by
that person or on their behalf.
(fabricant)
device that is intended for
use in relation to animals. (instrument
mé
dical)
ufacturer, that
differ only in shape, colour, flavour or size,
that have the same design and
manufacturing process and that have the
same intended use. (famille
d'instruments)
s, such as a procedure pack
or tray, that is sold under a single name.
(ensemble d'instrume
nts)
by
the same manufacturer, that have the same generic
name specifying their intended use,
and
that differ only in the number and combination of
products that comprise each group.
(famille d'ensembles
d'instruments)
or the user to identify the
device and to distinguish it from similar devices.
(nom de l'instr
ument)
tic
device that is intended for use outside a
laboratory, for testing at home or at the point
of care, such as a pharmacy, a health
care professional's office or the bedside.
(instrument
diagnostique clinique in
vitro)
hrough observation,
measurement, testing or other means, as set out in
the definition
ective
evidence
d ISO 8402:1994, Quality
management and quality assurance - Vocabulary, as
amended fr
om time to time. (preuve
tangible)
al association of persons
entitled under the laws of a province to provide
health care in th
e province and who is
designated, by the ethics committee of the health
care facility at wh
ich investigational
testing is to be conducted, as the person to
conduct the testing. (cherch
eur
compé
tent)
manufacturer,
importer or distributor of the device to recall or
correct the device, or to no
tify its
owners and users of its defectiveness or potential
defectiveness, after becoming aw
are
that the device
(a) may be hazardous to
health;
(b) may fail to conform to any claim
made by the manufacturer or importer relating to
its
effectiveness, benefits,
performance characteristics or safety;
or
(c) may not meet the requirements of
the Act or these Regulations. (rappel)
et
out in sections 10 to 20. (exigences en
matiè
re de s?
reté
et d'efficacité
)
bnormal physical
state, the permanent impairment of a body function
or permanent damag
e to a body
structure, or a condition that necessitates an
unexpected medical or surgical
in
tervention to prevent such a disease,
disorder or abnormal physical state or permanent
im
pairment or damage.
(dé
té
rioration grave de
l'é
tat de santé
)
y or
effectiveness of a medical device. It includes a
change to any of the following:
(a) the
manufacturing process, facility or
equipment;
(b) the manufacturing quality control
procedures, including the methods, tests or
procedur
es used to control the quality,
purity and sterility of the device or of the
materials used in
its
manufacture;
(c) the design of the device, including
its performance characteristics, principles of
operat
ion and specifications of
materials, energy source, software or accessories;
and
(d) the intended use of the device,
including any new or extended use, any addition or
del
etion of a contra-indication for the
device and any change to the period used to
establish i
ts expiry date.
(modification importante)
cal or dental
use, including cutting, drilling, sawing,
scraping, clamping, hammering,
pun
cturing, dilating, retracting or
clipping, without connection to an active device.
(instrume
nt chirurgical ou
dentaire)
rough an artificially
created opening that provides access to body
structures and fluids. (i
nstrument
effractif chirurgical)
o be used
together to fulfil some or all of the device's
intended functions, and that is sold
under a single name.
(systè
me)
ombination of
these, and that is intended to be used to conduct
a specific test. (trousse
d'e
ssai)
hat the
requirements for a specific intended use have been
fulfilled, as set out in the defini
tion
d ISO 8402:1994, Quality management and
quality assurance - Vocabulary, as amended
fr
om time to time.
(validation)
APPLICATION
2. These Regulations apply
to
(a) the sale and advertising for sale
of a medical device; and