Regulatory requirements for in-house IVDs

Name: Regulatory requirements for in-house IVDs
Creator: Therapeutic Goods Administration
Keywords: diagnostics,guidances,guide,in-house,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,medical-devices,requirements

Information

Original link

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

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

Published

May 1, 2024

Last updated

May 1, 2024

Description

A guide to following regulatory requirements for in-house IVDs in vitro diagnostic medical devices (IVDs).

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

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4 Main files

Regulatory requirements for in-house IVDs

Updated on May 1, 2024

pdf

URL: https://www.tga.gov.au/sites/default/files/regulatory-requirements-in-house-ivds.pdf
Permalink: https://data.openrid.co/en/datasets/r/18733980-ab41-4e4a-b00c-50e6a045cbe9
MIME Type: application/pdf

Created on: May 1, 2024
Modified on: May 1, 2024

Regulatory requirements for in-house IVDs

Updated on May 1, 2024

docx

URL: https://www.tga.gov.au/sites/default/files/2024-05/regulatory-requirements-in-house-ivds.docx
Permalink: https://data.openrid.co/en/datasets/r/8a5c4937-e954-408b-9263-b94ce3e8b20f
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: May 1, 2024
Modified on: May 1, 2024

In-house IVD notification template

Updated on May 1, 2024

xlsx

URL: https://www.tga.gov.au/sites/default/files/2024-05/in-house-ivd-notification-template.xlsx
Permalink: https://data.openrid.co/en/datasets/r/54c9c958-4e9f-4fc9-86af-9e1d5ccea940
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: May 1, 2024
Modified on: May 1, 2024

Regulatory requirements for in-house IVDs

Updated on May 1, 2024

html

URL: https://www.tga.gov.au/resources/resource/guidance/regulatory-requirements-house-ivds
Permalink: https://data.openrid.co/en/datasets/r/c9229994-d10e-4cc5-9a1f-a2a545eb25bb
MIME Type: text/html

Created on: May 1, 2024
Modified on: May 1, 2024

Regulatory requirements for in-house IVDs

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

License

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