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MEDICAL DEVICES


LABEL REVIEW

MEDERA can also handle the associated review of product labels to ensure compliance with Canadian labelling regulations (package labels, cartons, and product inserts). Our medical device regulatory affairs services include pre-approval label reviews or label development to guide you on compliance with Canadian Regulations and advise you on changes to labelling which will help maximize claims and/or expedite product approvals.

MEDERA is also offering post-approval label reviews to ensure compliance with the marketing authorization or to help you determine if supplemental filings are required to support your proposed changes to the approved label.

Contact us to find out more about our regulatory consulting services or to receive a free copy of our white paper on marketing a healthcare product in Canada, click here.