AUSTRALIA TGA (2015) - ADVISORY COMMITTEE ON THE SAFETY OF MEDICAL DEVICES

* ALL LINKS TO CONDITIONS (RESTRICTED REPRESENTATIONS) OR PRODUCTS THAT HAVE NOT CONFORMED TO PRE REGISTRATION APPROVAL ARE REMOVED AT THE DIRECTION OF THE AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION (16 JUNE 2020)

  • The Australian TGA Advisory Committee on the Safety of Medical Devices, "cancelled" the registration and certification of all soft 'mild' hyperbaric chambers.

 

 * Sellers and therapists providing soft and mild HBOT systems to the public must be aware that they may be subject to "criminal prosecution" under the TGA and ACCC for unregistered chamber sales and 'risks to public safety'.

 

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