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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.859830&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | Fees for the review of medical device licence applications : guidance document. |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| 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. |
| Information sur la publication | Ottawa, Ontario : Health Canada = Santé Canada, November 2019. ©2019 |
| Description | 1 online resource (15 pages) |
| ISBN | 9780660274393 |
| Numéro de catalogue |
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| Numéro de catalogue du ministère | Pub.: 180196 |
| Descripteurs | Medical instruments and apparatus industry -- Licenses -- Fees -- Canada. |