Transition to new manufacturer evidence for IVD medical devices

Name: Transition to new manufacturer evidence for IVD medical devices
Creator: Therapeutic Goods Administration
Keywords: case-studies,diagnostics,evidence,guidances,in-vitro-diagnostics,ivd,manufacturers,medical-devices,requirements,sponsors,transition

Information

Original link

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

In Vitro Diagnostic Medical Devices (IVDs)

Published

June 14, 2023

Last updated

February 29, 2024

Description

This guidance is to help sponsors and manufacturers of in vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

Feedback

Suggest an improvement to this page

5 Main files

Transition to new manufacturer evidence for IVD medical devices

Updated on February 29, 2024

pdf

URL: https://www.tga.gov.au/sites/default/files/2023-06/transition-to-new-manufacturer-evidence-for-ivd-medical-devices.pdf
Permalink: https://data.openrid.co/en/datasets/r/21b02f49-c805-4b4e-9cad-0f6c6ceaf847
MIME Type: application/pdf

Created on: June 14, 2023
Modified on: February 29, 2024

Transition to new manufacturer evidence for IVD medical devices

Updated on February 29, 2024

docx

URL: https://www.tga.gov.au/sites/default/files/2023-06/transition-to-new-manufacturer-evidence-for-ivd-medical-devices.docx
Permalink: https://data.openrid.co/en/datasets/r/1b96c6a3-d77d-4e49-8198-61afc1d29d57
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: June 14, 2023
Modified on: February 29, 2024

Additional case studies and scenarios

Updated on February 29, 2024

pdf

URL: https://www.tga.gov.au/sites/default/files/2023-11/additional-case-studies-scenarios.pdf
Permalink: https://data.openrid.co/en/datasets/r/8064af7b-5b00-4e20-9a34-8d94eef3c565
MIME Type: application/pdf

Created on: June 14, 2023
Modified on: February 29, 2024

Additional case studies and scenarios

Updated on February 29, 2024

docx

URL: https://www.tga.gov.au/sites/default/files/2023-11/additional-case-studies-scenarios.docx
Permalink: https://data.openrid.co/en/datasets/r/1bbbd708-a70a-411c-89bb-d5fe8b1882cf
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: June 14, 2023
Modified on: February 29, 2024

Transition to new manufacturer evidence for IVD medical devices

Updated on February 29, 2024

html

URL: https://www.tga.gov.au/resources/resource/guidance/transition-new-manufacturer-evidence-ivd-medical-devices
Permalink: https://data.openrid.co/en/datasets/r/e40aed8a-38f2-4ba5-9e47-9f07281597ce
MIME Type: text/html

Created on: June 14, 2023
Modified on: February 29, 2024

Transition to new manufacturer evidence for IVD medical devices

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

Actions

Social networks

Embed