Classification of decorative contact lenses
As of July 16, 2016, decorative contact lenses will be
considered Class II medical devices. Medical devices are
classified into four classes, with Class I representing the
lowest risk class and Class IV the highest.
Requirement for manufacturers
As a manufacturer, you must obtain a medical device
licence before advertising or selling any Class II, III or IV
medical devices. This means that before you can sell decorative contact lenses in Canada, you will need to get a Class
II medical device icence for your lenses.
Information for applying for a medical device licence
To apply for a Class II medical device licence, manufacturers of decorative contact lenses must get ISO 13485:2003
certification from one of the recognized registrars in the
Canadian Medical Device Decorative contact lenses Conformity Assessment System (CMDCAS). The certificate
must contain the Standards Council of Canada logo as well
as a CMDCAS recognition statement.
You can find a list of recognized registrars at http://www.
hc-sc.gc.ca/dhp-mps/md-im/qualsys/list_liste_registeng.php
manufacturers are being given a 12-month transition period to get
their Class II medical device licence. After July 16, 2017, all manufacturers, importers and distributors who sell decorative contact
lenses in Canada may face enforcement action if their lenses are
not licensed by Health Canada.
DECORATIVE CONTACT LENSES
Requirements for importers and distributors
If you distribute or import medical devices, you do not need a
medical devices licence. Instead, you must apply for and obtain
a medical device establishment licence (MDEL). In doing so, you
are providing assurance that the medical devices you sell or import into Canada meet the safety and effectiveness requirements
set out in the Regulations, and that you have procedures in place
to protect the public should a problem with a medical device be
identified. These should include procedures related to distribution
records; complaint handling and recalls; mandatory problem
reporting; and the handling, storage, delivery, installation and
servicing of any Class II, III or IV devices, where applicable.
Along with the ISO 13485:2003 certificate, manufacturers
must also submit a completed Class II application form
(found at www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/
md-im/applic- demande/form/licapp_demhom_cla2-eng.
pdf) and fee form (found at www.hc-sc.gc.ca/dhp- mps/
alt_formats/pdf/md-im/applic-demande/form/md_licapp_demhom-eng.pdf), as well as a copy of the labelling
used for their lenses.
You should send your medical device licence
application to: Device Licensing Services Division
Medical Devices Bureau Therapeutic Products Directorate
Health Canada 11 Holland Avenue Address locator: 3002A
Ottawa, Ontario K1Y 4T2 For more information on
medical device licensing, please visit the medical devices
section of Health Canada’s website. You can also email
[email protected] or call 613-957-7285 with
any questions or concerns.
COMPLIANCE AND ENFORCEMENT
Transition period for manufacturers
As a manufacturer of decorative contact lenses, you will
need to have your licence before you can sell your product
in Canada. However, because decorative contact lenses
are not considered medical devices until July 16, 2016,
any application for licensing you submit before that date
will not be accepted by Health Canada. For this reason, all
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