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 compliance.
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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