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Fees for the review of medical device licence applications : guidance document.: H13-9/20-2019E-PDF

"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.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.859830&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleFees for the review of medical device licence applications : guidance document.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • 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.
Publishing information
  • Ottawa, Ontario : Health Canada = Santé Canada, November 2019.
  • ©2019
Description1 online resource (15 pages)
ISBN9780660274393
Catalogue number
  • H13-9/20-2019E-PDF
Departmental catalogue numberPub.: 180196
Subject terms
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