therapeutic devices - Robuta Search

https://www.tga.gov.au/resources/guidance/classifying-vitro-diagnostic-medical-devices-ivds-supply-australia

Classifying in-vitro diagnostic medical devices (IVDs) for supply in Australia | Therapeutic Goods...

Classifying in-vitro diagnostic medical devices (IVDs) according to the health risk that may arise from an incorrect result.

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https://www.tga.gov.au/resources/guidance/meeting-clinical-evidence-requirements-vitro-diagnostic-ivd-medical-devices

Meeting clinical evidence requirements for in-vitro diagnostic (IVD) medical devices | Therapeutic...

Guidance to understand how we interpret regulations and how manufacturers can comply with them.

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https://www.nist.gov/publications/therapeutic-and-drug-delivery-devices

Therapeutic and Drug Delivery Devices | NIST

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https://www.legislation.gov.au/F2014L00349/asmade/order-print-copy

Therapeutic Goods (Medical Devices) Amendment (Auditing Applications) Regulation 2014 - Federal...

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https://www.aapc.com/codes/icd-10-codes/Y79.1

ICD-10 Code for Therapeutic (nonsurgical) and rehabilitative orthopedic devices associated with...

ICD-10 code Y79.1 for Therapeutic (nonsurgical) and rehabilitative orthopedic devices associated with adverse incidents is a medical classification as

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https://www.tga.gov.au/products/medical-devices/system-and-procedure-packs/manufacturing/systems-are-medical-devices

Systems that are medical devices | Therapeutic Goods Administration (TGA)

Advice about systems that are medical devices for sponsors and manufacturers.

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https://www.tga.gov.au/products/medical-devices/supply-and-distribution/importing-and-supplying-medical-devices

Importing and supplying medical devices | Therapeutic Goods Administration (TGA)

Information for health professionals importing and supplying medical devices.

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https://www.databridgemarketresearch.com/reports/global-therapeutic-devices-for-dry-eye-market

Therapeutic Devices for Dry Eye Market Size, Trends, Growth Report 2032

The Global Therapeutic Devices for Dry Eye Market was valued at USD 2.00 Billion in 2024 and is expected to reach USD 3.90 Billion by 2032, growing at a CAGR...

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https://www.tga.gov.au/resources/publication/meeting-statements/advisory-committee-medical-devices-meeting-87

Advisory Committee on Medical Devices, Meeting 87 | Therapeutic Goods Administration (TGA)

The 87th meeting of the Advisory Committee on Medical Devices (ACMD) was held on 9 October 2025.

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https://www.tga.gov.au/news/safety-updates/medical-devices-safety-update-volume-2-number-3-may-2014

Medical Devices Safety Update, Volume 2, Number 3, May 2014 | Therapeutic Goods Administration (TGA)

Medical Devices Safety Update, Volume 2, Number 3, May 2014

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https://www.legislation.gov.au/F2002B00237/2021-07-28

Therapeutic Goods (Medical Devices) Regulations 2002 - Federal Register of Legislation

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https://www.marketresearch.com/Renub-Research-v3619/Europe-Sleep-Apnea-Devices-Types-37395627/

Europe Sleep Apnea Devices Market Report by Types (Therapeutic Devices, and Diagnostic Devices),...

Europe Sleep Apnea Devices Market Report by Types (Therapeutic Devices, and Diagnostic Devices), Therapeutic Devices (CPAP Sleep Apnea Therapeutic Devices,...

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https://www.tga.gov.au/resources/publication/meeting-statements/medical-devices-consumer-working-group-meeting-16

Medical Devices Consumer Working Group, Meeting 16 | Therapeutic Goods Administration (TGA)

Meeting statement from the 16th Consumer Working Group (CWG) meeting that took place on 25 March 2025.

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https://www.tga.gov.au/resources/guidance/defining-joint-replacement-medical-devices-and-ancillary-medical-devices

Defining joint replacement medical devices and ancillary medical devices | Therapeutic Goods...

Guidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.

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https://www.legislation.gov.au/F2014L01716/asmade/text

Therapeutic Goods (Medical Devices) Amendment (Registry Systems for Enhancing Safety) Regulation...

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https://www.tga.gov.au/products/regulations-all-products/tga-reforms/medical-devices-reforms/medical-devices-reforms-consumerpatient-information-materials-requirements

Medical devices reforms: consumer/patient information materials requirements | Therapeutic Goods...

The transition period is now over. We have also added some information for health professionals.

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https://www.tga.gov.au/products/medical-devices/manufacturing/obtain-and-maintain-regulatory-evidence/manufacturer-evidence-medical-devices

Manufacturer Evidence for medical devices | Therapeutic Goods Administration (TGA)

Medical device and in vitro diagnostic (IVD) applications require a Manufacturer's Evidence application.

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https://www.tga.gov.au/resources/guidance/understanding-regulation-label-use-medical-devices

Understanding regulation of off-label use of medical devices | Therapeutic Goods Administration...

Guidance on the use of a medical device in a way that is not included in the intended purpose in the Australian Register of Therapeutic Goods (ARTG), and rules...

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