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Class III IVD applications content and classification guidance.: H164-409/2025E-PDF

"Any information submitted to Health Canada should be accompanied by a cover letter. The cover letter should include the purpose of the application and a brief description of the package being submitted. It may also include proprietary information pertaining to the submission"--Health Canada guidance, page 5.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.957363&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleClass III IVD applications content and classification guidance.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • Cover title.
  • Issued also in French under title: Lignes directrices sur le contenu et la classification des demandes d'homologation d'instruments diagnostique in vitro de classe III.
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, November 2025.
  • ©2025
Description1 online resource (108 pages)
ISBN9780660797458
Catalogue number
  • H164-409/2025E-PDF
Departmental catalogue number250349
Subject terms
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