00000nam 2200000zi 4500 9.886859 CaOODSP 20221107171534 m o d f cr cn||||||||| 200505t20132013onc o f000 0 eng d CaOODSP eng rda CaOODSP n-cn--- H13-9/21-2013E-PDF Guidance document : medical device licence renewal and fees for the right to sell licensed medical devices / Health Products and Food Branch. Health Canada guidance document : medical device licence renewal and fees for the right to sell licensed medical devices Ottawa, Ontario : Health Canada = Santé Canada, 2013. ©2013 1 online resource (iii, 13 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Ligne directrice : renouvellement de l'homologation d'un matériel médical et frais à payer pour le droit de vendre un instrument médical homologué. "November 18, 2013." Issued also in HTML format. "This guidance document provides medical device manufacturers and their regulatory correspondents with the steps involved in renewing a medical device licence. The renewal process has two purposes: the first is to confirm whether the medical device will continue to be sold in Canada and the medical device licence will remain active; the second is to collect information that must be assessed prior to invoicing for the right to sell fee. This guidance document also provides guidance on the Fees in Respect of Drugs and Medical Devices Regulations (Fee Regulations) with a focus on how the Fees for the Right to Sell Licensed Class II, III or IV Medical Devices, contained in Part 3, Division 3 of these regulations, will be administered"--Introduction, page 1. Medical instruments and apparatus Government policy Canada. Canada. Health Canada. Canada. Health Products and Food Branch. Ligne directrice : (CaOODSP)9.886861 PDF 320 KB https://publications.gc.ca/collections/collection_2020/sc-hc/H13-9-21-2013-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-medical-device-licence-renewal-fees-right-sell-licensed.html