Boundary and combination products

Name: Boundary and combination products
Creator: Therapeutic Goods Administration
Keywords: biological,combination-products,examples,guidances,guide,medical-devices,medicines,sponsors,therapeutic-goods

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Therapeutic Goods Regulation

Published

May 3, 2024

Last updated

May 3, 2024

Description

A guide to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices.

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

Feedback

Suggest an improvement to this page

5 Main files

Guidance on boundary and combination products

Updated on May 3, 2024

pdf

URL: https://www.tga.gov.au/sites/default/files/2023-12/guidance-boundary-combination-products.pdf
Permalink: https://data.openrid.co/en/datasets/r/dfa2fbbe-3a36-4536-be76-0122e0889868
MIME Type: application/pdf

Created on: May 3, 2024
Modified on: May 3, 2024

Guidance on boundary and combination products

Updated on May 3, 2024

docx

URL: https://www.tga.gov.au/sites/default/files/2023-12/guidance-boundary-combination-products.docx
Permalink: https://data.openrid.co/en/datasets/r/195a9b26-cff6-4ad9-ba27-3aa64a8c8ba8
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: May 3, 2024
Modified on: May 3, 2024

Examples of boundary and combination products and their product category

Updated on May 3, 2024

pdf

URL: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.pdf
Permalink: https://data.openrid.co/en/datasets/r/691c6787-2778-458e-b93f-6bbe65ab862e
MIME Type: application/pdf

Created on: May 3, 2024
Modified on: May 3, 2024

Examples of boundary and combination products and their product category

Updated on May 3, 2024

docx

URL: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.docx
Permalink: https://data.openrid.co/en/datasets/r/c7a2b187-def3-428d-b33c-e1727a20c5fb
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: May 3, 2024
Modified on: May 3, 2024

Boundary and combination products

Updated on May 3, 2024

html

URL: https://www.tga.gov.au/resources/resource/guidance/boundary-and-combination-products
Permalink: https://data.openrid.co/en/datasets/r/db1d6ee1-b288-4653-9427-ef98d9b4e8d7
MIME Type: text/html

Created on: May 3, 2024
Modified on: May 3, 2024

Boundary and combination products

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

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