By Stewart Eisenhart, Emergo Group
Health Canada official has informed Emergo Group that Canadian medical device manufacturers should consider exports of their products as sales when calculating revenues and determining Medical Device Establishment License (MDEL) fees.
According to Health Canada’s Health Products & Food Branch Inspectorate, MDEL holders should consider revenues from exports from Canada as revenue generated under their MDELs, and must capture export revenues in their Certified Statements of Revenue under Canada’s Food and Drugs Act (PDF).
Canadian Medical Device Establishment License (MDEL) holders should evaluate their processes for determining gross sales and Health Canada fees to ensure compliance with current policy.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
