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TGA MD Guidance: Medical Device Labelling Obligations

Updated: Feb 24

On Monday (19 February, 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance on the "Medical Device Labelling Obligations" which assist manufacturers and sponsors in fulfilling their responsibilities in medical device labelling requirements.


The Therapeutic Goods Administration (TGA) in Australia regulates the supply of medical devices to ensure their safety, quality, and effectiveness. One crucial aspect of regulatory compliance for medical devices is labelling.


The TGA has issued guidance outlining the labelling obligations for medical devices to help manufacturers, sponsors, and other stakeholders understand and comply with the requirements.


The manufacturer of a medical device is the person responsible for the:

  • design

  • production

  • packaging and

  • labelling of the device. 


Medical device manufacturers need evidence that they follow the Essential Principles. This includes those that relate to labelling and instructions for use. On the device's label, it must include:

  • the manufacturer's name and address, 

  • instructions for use and other information provided with the medical device.


Key Objectives of the Guidance

  1. Ensuring Safety and Effectiveness: The primary objective of the labelling requirements is to ensure that medical devices are used safely and effectively by healthcare professionals and patients.

  2. Facilitating Traceability and Identification: Proper labelling helps in the identification and traceability of medical devices throughout their lifecycle, including manufacturing, distribution, and use.

  3. Compliance with Regulatory Requirements: The guidance helps manufacturers and sponsors understand the specific labelling requirements set forth by the TGA and comply with them.


Click this link to know more about the Sponsor's ongoing responsibilities and Therapeutic Goods (Medical Devices) Regulations 2002 outlines the labelling and instructions requirements for medical devices.



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