On February 19, 2024, the Australian regulatory authority, Therapeutic Good Administration (TGA), updated the requirements regarding the labelling of Medical Devices detailing the obligations of the Manufacturer and Sponsor.
The manufacturer of a medical device, who is also responsible for labelling, must include information such as the name and address of the manufacturer.
Furthermore, the relabelling of devices by a party other than the Manufacturer, e.g. the Sponsor, does not make it a Manufacturer.
The Sponsor, i.e. the person who adds a Medical Device to the Australian Register of Therapeutic Products, must ensure that their name and address appear on the labelling. However, if this is not possible, the information must be included on the packaging or the leaflet. Moreover, in the latest update, it is specified that the label must not in any way modify the device or obscure the information provided with the device by the manufacturer.
Information to be included on the label by the Manufacturer
- Manufacturer’s name or trade name and address;
- Intended use, user, patient of the device;
- Sufficient information for the user to identify the device or package contents;
- Any special handling or storage requirements applicable to the device;
- Any warnings, restrictions or precautions concerning the device;
- Any special operating instructions for using the device;
- Indication ‘for single use only’, if applicable;
- Indication that the device has been custom-made, if applicable;
- Indication that the device is intended for pre-marketing clinical investigations, if applicable;
- Insertion of the word ‘sterile’ and the method of sterilisation, if sterile device;
- Entry of batch code, batch number or serial number of the device;
- Indication of the date (month and year) until which the device can be safely used, if applicable.
The TGA’s updating of the labelling requirements for Medical Devices aims to update the Australian regulatory framework to keep pace with other countries around the world such as the USA, Europe and China, ensuring safe and effective devices and thus safeguarding patients’ lives.
>> Through the services of strategic-regulatory consulting Thema supports the registration with Therapeutic Good Administration for the marketing of Medical Devices and IVDs in Australia.
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