Provisional determination eligibility criteria

Name: Provisional determination eligibility criteria
Creator: Therapeutic Goods Administration
Keywords: applications,assessment,clinical-studies,criteria,data,examples,guidances,updates

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Prescription Medicines, Prescription Medicines Collection

Published

August 26, 2021

Last updated

August 26, 2021

Description

Update to currency of data required for criteria assessment

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

Feedback

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3 Main files

Example clinical study plan for provisional determination application

Updated on August 26, 2021

docx

URL: https://www.tga.gov.au/sites/default/files/example-clinical-study-plan-for-provisional-determination-application.docx
Permalink: https://data.openrid.co/en/datasets/r/ebbbe40d-eeb5-4741-ad7f-4c86ad670d18
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: August 26, 2021
Modified on: August 26, 2021

Provisional determination eligibility criteria

Updated on August 26, 2021

pdf

URL: https://www.tga.gov.au/sites/default/files/provisional-determination-eligibility-criteria.pdf
Permalink: https://data.openrid.co/en/datasets/r/1cd0a835-cd81-49bc-bb5a-f52a362e3b78
MIME Type: application/pdf

Created on: August 26, 2021
Modified on: August 26, 2021

Provisional determination eligibility criteria

Updated on August 26, 2021

html

URL: https://www.tga.gov.au/resources/resource/guidance/provisional-determination-eligibility-criteria
Permalink: https://data.openrid.co/en/datasets/r/fda74de4-0bbb-472e-b233-40b696a943bf
MIME Type: text/html

Created on: August 26, 2021
Modified on: August 26, 2021

Provisional determination eligibility criteria

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

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