On October 18, 2014, proposed regulations seeking to amend the
Medical Devices Regulations (Regulations) were published
in the Canada Gazette. The amendment would address two issues,
specifically (i) a general requirement regarding label submission
for all Class II medical device licence applications, and (ii) a
specific requirement relating to the classification of
non-corrective contact lenses.
As background, in Canada, medical devices are classified into
four classes (I to IV); each class corresponds to an increasing
risk profile, with Class IV being the highest risk. Manufacturers
are required under the Regulations to ensure the safety and
effectiveness of the medical devices that are sold in Canada.
If the proposed amendment is passed, submission of a draft label
would be required for all Class II medical device applications.
Examples of Class II medical devices include surgical gloves and
syringes. Presently, only an attestation from the manufacturer that
its proposed label is in compliance with regulatory requirements is
needed when completing a licence application; although in practice,
many manufacturers do submit a draft label with the licence
application, either voluntarily or following a request from Health
Canada after the application has been submitted. Health
Canada's rationale for this change is to address
misclassification and improper labelling concerns currently
associated with Class II medical devices.
The proposed amendment also seeks to classify non-corrective
contact lenses as Class II medical devices, notwithstanding the
fact that these products are not intended for treatment or
diagnostic purposes. Currently, these products are considered to be
consumer products, regulated under the Canada Consumer Product
Safety Act, and therefore do not require pre-market review
before being sold in Canada. Should the proposed amendment pass,
manufacturers would be required to obtain a medical device licence
prior to selling or importing non-corrective contact lenses in
Canada. Similarly, importers and distributors would be required to
hold a medical device establishment licence. In order to address
the fact that non-corrective contact lenses have no therapeutic
effects, the proposed amendment would exempt these products from
the effectiveness requirements of the Regulations. If enacted, the
new rules for non-corrective contact lenses would not come into
force for 12 months following the registration of the amendment, to
allow manufacturers time to update their operations for
In conjunction with the proposed amendment, Health Canada has
released a set of draft guidance documents and applications forms
(click here for access to these
documents). Stakeholders are invited to provide comments to Health
Canada on the proposed amendment and the related guidance documents
by January 3, 2015.
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