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040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-309/2026E-PDF
24500|aGuidance on summary reports and issue-related analyses for medical devices.
250 |a[April 2026 edition].
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cApril 2026.
264 4|c©2026
300 |a1 online resource (ii, 18 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aIssued 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.
500 |a"Health Products."
500 |a"Pub.: 250497"--Verso of cover.
504 |aIncludes bibliographical references.
520 |a"This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39, 61.4 to 61.6 and 68.31 to 68.33 of the Medical Devices Regulations (regulations). Two requirements in the regulations were added to ensure the continued monitoring of benefits and risks after a product is authorized for sale in Canada. The 2 requirements concern: the preparation, retention and submission of summary reports (sections 61.4 to 61.6 and 68.31 to 68.33 of the regulations); the completion of issue-related analyses of safety and effectiveness (subsection 25(1) and sections 39 and 68.23 of the regulations). This guidance document: clarifies Health Canada's expectations for the preparation of these summary reports and issue-related analyses; gives an overview of the requirements and procedures for submitting summary reports and issue-related analyses to Health Canada. …"-- Purpose of the guidance document, pages 1-2.
650 0|aMedical instruments and apparatus|xGovernment policy|zCanada.
650 0|aMedical instruments and apparatus|xSafety regulations|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLignes directrices sur les rapports de synthèse et les analyses liées à un sujet de préoccupation pour les instruments médicaux.|w(CaOODSP)9.960791
795 |tGuidance on summary reports and issue-related analyses for medical devices.|b[October 2024 edition]|w(CaOODSP)9.943289
85640|qPDF|s674 KB|uhttps://publications.gc.ca/collections/collection_2026/sc-hc/H164-309-2026-eng.pdf
8564 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance.html
986 |a250327