Guidance for Declaration of Conformity Procedures

Name: Guidance for Declaration of Conformity Procedures
Creator: Therapeutic Goods Administration
Keywords: class-1,class-i,declaration-of-conformity,declarations,diagnostics,doc,export,guidances,in-vitro-diagnostics,ivd,medical-devices,procedures

Information

Original link

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Therapeutic Goods Regulation, In Vitro Diagnostic Medical Devices (IVDs)

Published

November 26, 2021

Last updated

November 26, 2021

Description

Self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

Feedback

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3 Main files

Guidance for Declaration of Conformity for Class I non-sterile non-measuring and Class 1 in vitro diagnostic (IVD) medical devices

Updated on November 26, 2021

pdf

URL: https://www.tga.gov.au/sites/default/files/guidance-declaration-conformity-class-i-non-sterile-non-measuring-and-class-1-vitro-diagnostic-ivd-medical-devices.pdf
Permalink: https://data.openrid.co/en/datasets/r/65d8b159-e10b-40a5-8145-d56b05d17f92
MIME Type: application/pdf

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

Guidance for Declaration of Conformity for Class I non-sterile non-measuring and Class 1 in vitro diagnostic (IVD) medical devices

Updated on November 26, 2021

docx

URL: https://www.tga.gov.au/sites/default/files/guidance-declaration-conformity-class-i-non-sterile-non-measuring-and-class-1-vitro-diagnostic-ivd-medical-devices.docx
Permalink: https://data.openrid.co/en/datasets/r/5f2a5b93-6667-4d9b-a574-42f13b5cca28
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

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

Guidance for Declaration of Conformity Procedures

Updated on November 26, 2021

html

URL: https://www.tga.gov.au/resources/resource/guidance/guidance-declaration-conformity-procedures
Permalink: https://data.openrid.co/en/datasets/r/0fe24e8d-6bf2-4861-8a72-87cfcc9a6c25
MIME Type: text/html

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

Guidance for Declaration of Conformity Procedures

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

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