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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.895017&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance on summary reports and issue-related analyses for medical devices. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| 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. |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, 2021. ©2021 |
| Description | 1 online resource (i, 11 pages) |
| ISBN | 9780660370385 |
| Catalogue number |
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| Departmental catalogue number | 200333 |
| Subject terms | Medical instruments and apparatus -- Safety regulations -- Canada. Medical instruments and apparatus -- Government policy -- Canada. |