00000nam 2200000zi 4500 9.859830 CaOODSP 20221107160338 m o d f cr ||||||||||| 180730e201911##onc o f000 ||eng d 9780660274393 CaOODSP eng rda CaOODSP n-cn--- H13-9/20-2019E-PDF Fees for the review of medical device licence applications : guidance document. Ottawa, Ontario : Health Canada = Santé Canada, November 2019. ©2019 1 online resource (15 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Cover title. Issued also in French under title: Frais pour l'examen des demandes d'homologations des instruments médicaux : ligne directrice. "Effective date: 2020/04/01." Issued also in HTML format. "Before a medical device is authorized for sale in Canada, scientific evidence of its safety, efficacy and quality, as required by the Food and Drugs Act and Regulations, must be provided to Health Canada to determine whether the benefits associated with the product outweigh the risks. Health Canada has charged industry fees for these pre-market regulatory activities since 1998 in order to recover some of the associated costs"--Introduction, page 6. Medical instruments and apparatus industry Licenses Fees Canada. Canada. Health Canada, issuing body. Frais pour l'examen des demandes d'homologations des instruments médicaux : (CaOODSP)9.859831 PDF 265 KB https://publications.gc.ca/collections/collection_2022/sc-hc/H13-9-20-2019-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/fees-review-medical-device-licence-applications-2019/document.html Pub.: 180196