Guidance on summary reports and issue-related analyses for medical devices. : H164-309/2021E-PDF
"This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulations. Two new requirements in the Regulations were added to ensure the continued monitoring of benefits and risks after a product is authorized for sale in Canada"--Purpose of the guidance document, page 1.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.895017&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | Guidance on summary reports and issue-related analyses for medical devices. |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| Note(s) | Cover title. Issued also in HTML format. "Publication date: January 2021." Issued also in French under title: Lignes directrices sur les rapports de synthèse et les analyses liées à un sujet de préoccupation pour les instruments médicaux. |
| Information sur la publication | Ottawa, ON : Health Canada = Santé Canada, 2021. ©2021 |
| Description | 1 online resource (i, 11 pages) |
| ISBN | 9780660370385 |
| Numéro de catalogue |
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| Numéro de catalogue du ministère | 200333 |
| Descripteurs | Medical instruments and apparatus -- Safety regulations -- Canada. Medical instruments and apparatus -- Government policy -- Canada. |