000	02086cam  2200373zi 4500
001	9.895017
003	CaOODSP
005	20221107173915
006	m     o  d f
007	cr cn|||||||||
008	210104t20212021onc     o    f000 0 eng d
020	|a9780660370385
040	|aCaOODSP|beng|erda|cCaOODSP
043	|an-cn---
086	1 |aH164-309/2021E-PDF
245	00|aGuidance on summary reports and issue-related analyses for medical devices.
264	1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2021.
264	4|c©2021
300	|a1 online resource (i, 11 pages)
336	|atext|btxt|2rdacontent
337	|acomputer|bc|2rdamedia
338	|aonline resource|bcr|2rdacarrier
500	|aCover title.
500	|aIssued also in HTML format.
500	|a"Publication date: January 2021."
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.
520	|a"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.
650	0|aMedical instruments and apparatus|xSafety regulations|zCanada.
650	0|aMedical instruments and apparatus|xGovernment policy|zCanada.
710	1 |aCanada. |bHealth Canada, |eissuing body.
775	08|tLignes directrices sur les rapports de synthèse et les analyses liées à un sujet de préoccupation pour les instruments médicaux.|w(CaOODSP)9.895018
856	40|qPDF|s688 KB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-309-2021-eng.pdf
856	4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance.html