Language selection

Government of Canada / Gouvernement du Canada

Search

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

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance on summary reports and issue-related analyses for medical devices.
Publication typeMonograph
Language[English]
Other language editions[French]
Later editionGuidance on summary reports and issue-related analyses for medical devices.
FormatDigital text
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
Description1 online resource (i, 11 pages)
ISBN9780660370385
Catalogue number
  • H164-309/2021E-PDF
Departmental catalogue number200333
Subject terms
Request alternate formats
To request an alternate format of a publication, complete the Government of Canada Publications email form. Use the form’s “question or comment” field to specify the requested publication.

Page details

Report a problem or mistake on this page
Date modified: