Guidance for manufacturer's declaration of conformity for system or procedure packs

Name: Guidance for manufacturer's declaration of conformity for system or procedure packs
Creator: Therapeutic Goods Administration
Keywords: assessment,class-1,class-i,conformity-assessment,declaration-of-conformity,declarations,doc,guidances,in-vitro-diagnostics,ivd,manufacturers,medical-devices,pathway,procedures,supplying

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Published

November 26, 2021

Last updated

November 26, 2021

Description

This guidance applies to manufacturers of medical devices that are regulated as 'system or procedure packs' and supplied using the special conformity assessment procedure regulatory pathway.

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

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3 Main files

Guidance – manufacturer’s declaration of conformity for system or procedure packs (other than Class I or Class 1 IVD system or procedure packs)

Updated on November 26, 2021

pdf

URL: https://www.tga.gov.au/sites/default/files/guidance-manufacturers-declaration-of-or-procedure-packs-other-than-class-l-or-class-1-ivd-system-or-procedure-packs.pdf
Permalink: https://data.openrid.co/en/datasets/r/afec5969-8819-4b62-b818-c13c8e6b221c
MIME Type: application/pdf

Created on: November 26, 2021
Modified on: November 26, 2021

Guidance – manufacturer’s declaration of conformity for system or procedure packs (other than Class I or Class 1 IVD system or procedure packs)

Updated on November 26, 2021

docx

URL: https://www.tga.gov.au/sites/default/files/guidance-manufacturers-declaration-of-or-procedure-packs-other-than-class-l-or-class-1-ivd-system-or-procedure-packs.docx
Permalink: https://data.openrid.co/en/datasets/r/28068980-3ff7-492f-9521-53e7af9a2670
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: November 26, 2021
Modified on: November 26, 2021

Guidance for manufacturer's declaration of conformity for system or procedure packs

Updated on November 26, 2021

html

URL: https://www.tga.gov.au/resources/resource/guidance/guidance-manufacturers-declaration-conformity-system-or-procedure-packs
Permalink: https://data.openrid.co/en/datasets/r/3cd32af4-7d3e-4e3c-a661-8da4821e88c9
MIME Type: text/html

Created on: November 26, 2021
Modified on: November 26, 2021

Guidance for manufacturer's declaration of conformity for system or procedure packs

Information

Type

Regulated products

Published

Last updated

Description

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Organization

Country / Region

License

Feedback

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