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New Guidance from Health Canada on Medical Device License Renewal

Health Canada has published new guidance for manufacturers of Class II, III and IV medical devices on the Medical Device License renewal process.

The Medical Device License renewal process entails manufacturers licensed to sell their products in Canada notifying Health Canada annually before November 1 if information submitted with their license applications have not changed.

Right-to-sell fees incurred by license holders for renewals depend on individual firms’ annual gross revenues. For firms with annual revenues of $20,000 or less from sales of medical devices in Canada, a right-to-sell fee is assessed at $50 according to Section 48. (1) (a) of the Free Regulations; firms with annual revenues above $20,000 will be charged $330.

License holders will see right-to-sell fees increase by two percent starting April 1, 2012.

For manufacturers that haven’t completed a full calendar year of selling in the Canadian market by the time license renewals are due, HC will defer their right-to-sell fees until the end of that year, according to the guidance.

The new guidance document, “Guidance Document – Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices,” replaces “Guidance for Industry – Medical Device Licence Renewal” published August 23, 2005.

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