The Therapeutic Goods Association (TGA) will reclassify certain medical devices from 25 November 2021. These devices include:
Active medical devices for therapy with a diagnostic function
Spinal implants for motion preservation
Devices in direct contact with the heart, central circulatory system, central nervous system
Devices that administer medicines or biologicals by inhalation
Active medical devices
Substances introduced into the body, body orifice or applied to the skin.
These reforms will align Australian medical device categorisation with changes introduced under European Union (EU) regimes.
Be aware:
If your device was included in the Australian Register of Therapeutic Goods (ARTG) before 25 November 2021, you must notify the TGA you have an inclusion for reclassification by 25 May 2022.
For applications for inclusion in the ARTG lodged before 25 November 2021, the device will be assessed per previous rules. However, you must notify the TGA of an inclusion to be reclassified by 25 May 2022, or within 2 months of the start of your ARTG entry (whichever is the later date).
Should you require further assistance regarding medical device reclassification or TGA notification requirements, Komply can help.
Komply advises and assists clients in end-to-end quality assurance, registration, regulatory, compliance, and commercialisation matters in human and veterinary applications.
Contact us directly at info@komplyaus.com for more information.
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