17
Volume1 Issue4
|
CDA
at
W
ork
UnlicensedDental Products:
PROTECTYOURSELFAND
YOURPATIENTS
The long-standingproblemof sales inunli-
censeddentalmaterialshasn’t diminished in
Canada, according toMr. Jugoon. Headmits
that it’sdifficult toestimate the scaleof the
issue, because salesof noncompliant prod-
ucts can’t be tracked. But thereare indica-
tions that theproblempersists.
“Onemeasureof howmanynoncompliant
products arecoming into theCanadian
dentalmarketplace is thenumber of flyers in
circulation that featureproductsofferedby
distributorswhowe knowarenot author-
ized to sell thoseproducts,” he says. “Based
on thismeasure, it looks like theproblem
isn’t goingaway.”
Dental products, suchasdental equipment
andmaterials, areconsiderednoncompliant
if 2 requirements arenotmet:
Theproduct doesnotmeetHealthCana-
da’s licensing requirements.Manufactur-
ersof dental products are responsible for
obtainingaMedical DeviceLicense from
HealthCanadabefore their product can
be sold.
Theproduct is importedor distributed
byanunauthorizeddealer—one that
doesnot holdanEstablishment Licence
fromHealthCanada.
However, thereare signsof improvement
for some typesof noncompliant products.
“Greymarket products are those that are
diverted from themanufacturer’s intended
market, usuallydevelopingcountries,
andfind theirway into theCanadian
market even if thedistributor isnot
authorized to sell that product in
Canada,”Mr. Jugoonexplains. For
these illegal products, the shipping,
handlingand storageconditions
mayhavean impact on theprod-
uct’squality. “I think that thedivert-
edproduct sector is flat, or even
decreasing, becausemanufacturers
havebeenworking to rebrandand
relabel for different countries.”
Salesof counterfeit products, on theother
hand,maybeon the rise. “What’s scary
about counterfeitproducts is that it’sdifficult
to tellwhat isor isn’t a legitimateproduct,”
he says. “Many times theseproducts are
beingusedwithout thedentist realizing it,
andultimatelywedon’t knowwhat isgoing
intopatients’mouths.”
Mr. Jugoon stresses the importanceof edu-
catingeveryone in thedental office—
especially those responsible for purchas-
ing—about theexistenceof noncompliant
dental products and the risks associated
with their use.
a
InMay, the Dental
Industry Association
of Canada (DIAC)
hosted a summit in
Toronto, bringing
together representatives
in the dental industry
and profession to
discuss how to prevent
noncompliant dental
products frommaking
their way into the
mouths of Canadian
patients. CDA partici-
pated in this event and
talked to Peter Jugoon,
DIAC past-president,
about this issue.
HaveConcerns
AboutaProduct?
• Search foravalidproduct license
throughHealthCanada’sonline
database,MedicalDevicesActiveLi-
cenceListing (MDALL):
• Search foracompany’svalidestab-
lishment license throughHealth
Canada’sonlinedatabase,Medical
DevicesEstablishmentLicenceList-
ing (MDEL):
• Examinepackaging fordefaced
product logosandpackaging,
repackagedproducts,missingorde-
faced lotnumbersandexpirydates,
and labelling that isn’tprovided
inbothEnglishandFrench.
Formore informationonthereg-
ulatoryrequirementsof instru-
ments, equipmentandmaterials
usedbyCanadiandentists, con-
sultthe
CDAGuidanceDocument
PertainingtoDevicesforUse in
DentalHealthCare:
PeterJugoon
