Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs)

Name: Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs)
Creator: Therapeutic Goods Administration
Keywords: applications,artg,assessment,australian-register-of-therapeutic-goods,authorization,conformity-assessment,evidence,guidances,in-vitro-diagnostic-medical-devices,inclusion,ivdmd,ivds,market-authorization,markets,medical-devices,overseas,tga

Information

Original link

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

In Vitro Diagnostic Medical Devices (IVDs)

Published

November 13, 2023

Last updated

November 13, 2023

Description

For abridgement of TGA conformity assessments and as information required for applications for ARTG inclusion

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

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3 Main files

Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices including IVDs

Updated on November 13, 2023

pdf

URL: https://www.tga.gov.au/sites/default/files/2023-11/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds.pdf
Permalink: https://data.openrid.co/en/datasets/r/6239f1af-516e-4dcc-b609-58ae53458f58
MIME Type: application/pdf

Created on: November 13, 2023
Modified on: November 13, 2023

Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices including IVDs

Updated on November 13, 2023

docx

URL: https://www.tga.gov.au/sites/default/files/2023-11/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds.docx
Permalink: https://data.openrid.co/en/datasets/r/6320a554-a9b5-4bd1-a2a9-e9c464cfa8fa
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: November 13, 2023
Modified on: November 13, 2023

Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs)

Updated on November 13, 2023

html

URL: https://www.tga.gov.au/resources/resource/guidance/use-market-authorisation-evidence-comparable-overseas-regulators-and-assessment-bodies-medical-devices-including-ivds
Permalink: https://data.openrid.co/en/datasets/r/82128ce8-2380-48ea-a83e-f62b1bb3c600
MIME Type: text/html

Created on: November 13, 2023
Modified on: November 13, 2023

Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs)

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Regulated products

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Published

Last updated

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Country / Region

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