Australian declaration of conformity templates (IVDs)

Name: Australian declaration of conformity templates (IVDs)
Creator: Therapeutic Goods Administration
Keywords: class-1,class-4,class-i,class-iv,declaration-of-conformity,declarations,diagnostics,doc,forms,in-house,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,manufacturers,medical-devices,templates

Information

Original link

Type

Form

Regulated products

IVDMD, Medical Devices

Topics

Manufacturing, In Vitro Diagnostic Medical Devices (IVDs)

Published

February 8, 2024

Last updated

February 8, 2024

Description

Templates for manufacturers to make Australian Declarations of Conformity for an in vitro diagnostic medical device.

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

Feedback

Suggest an improvement to this page

3 Main files

Template: Manufacturer's declaration of conformity - Class 4 in-house IVD medical devices

Updated on February 8, 2024

rtf

URL: https://www.tga.gov.au/sites/default/files/ivd-forms-declaration-conformity-class4.rtf
Permalink: https://data.openrid.co/en/datasets/r/cdc6d74b-8bc8-4ab8-9529-a843caab58f0
MIME Type: application/rtf

Created on: February 8, 2024
Modified on: February 8, 2024

Manufacturer’s Declaration of Conformity for Class I non-sterile, non-measuring or Class 1 in vitro diagnostic (IVD) medical devices

Updated on February 8, 2024

docx

URL: https://www.tga.gov.au/sites/default/files/template-declaration-conformity-class1-nsmd-s3-p6-c6-6.docx
Permalink: https://data.openrid.co/en/datasets/r/60dddb8d-e0d9-4523-871e-a50f1d6cf369
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: February 8, 2024
Modified on: February 8, 2024

Australian declaration of conformity templates (IVDs)

Updated on February 8, 2024

html

URL: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/tga-conformity-assessment/resources/resource/forms/australian-declaration-conformity-templates-ivds
Permalink: https://data.openrid.co/en/datasets/r/99667a04-44b5-4eb3-b1df-c8567380fec3
MIME Type: text/html

Created on: February 8, 2024
Modified on: February 8, 2024

Australian declaration of conformity templates (IVDs)

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

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