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Regulation of hypoxic therapy and altitude training devices (hypoxicators) in Australia

Consultation

5 September 2008

This consultation closed on 5 September 2008.

The following letter was sent to key industry organisations in July 2008. All interested stakeholders were invited to comment on this proposal.

Dear stakeholder

Consultation paper on the regulation of hypoxic therapy and altitude training devices (hypoxicators) in Australia

The Therapeutic Goods Administration (TGA) is seeking your comments on its proposal to develop an appropriate regulatory framework for hypoxic therapy and altitude training devices (hypoxicators). The proposed framework is outlined in the attached Consultation Paper.

Background

Hypoxicator products were discussed by the TGA's expert advisory Committee, the Medical Devices Evaluation Committee (MDEC), in 2007. The Committee raised a number of concerns regarding the safety of such products when used without constant supervision by qualified medical professionals. These concerns were not limited to the use of hypoxicators by the frail or unwell, but also applied to users who might otherwise be considered healthy individuals.

The MDEC was of the opinion that a hypoxicator was potentially hazardous, regardless of the manufacturer's intended purpose, and that their use could result in the user experiencing adverse side effects, such as hypoxaemia.

On 7 March 2008 the TGA National Manager hosted a meeting with relevant Australian and New Zealand stakeholders in the hypoxicator industry to discuss the TGA's safety concerns, and a possible way forward to regulate these products as medical devices.

It is proposed that hypoxicators be regulated as medical devices in Australia, based on the manufacturer's claims and intended purpose of the product.

The paper proposes that if the manufacturer's claims and intended purpose are limited to simulating air at altitude for professional training purposes; the hypoxicator would not fit the definition of a "medical device". Supply of these products in Australia would therefore not be regulated by the TGA. However, if the manufacturer's claims and intended purpose extend beyond generic altitude simulation, and include statements relating to possible physiological changes or therapeutic benefits, such products supplied in Australia would be regulated by the TGA as "medical devices".

Before a hypoxicator can be supplied in Australia as a medical device, the manufacturer must first obtain appropriate conformity assessment certification, and the Australian sponsor must then include the device in the ARTG.

Yours sincerely

Larry Kelly
A/g Director
Office of Devices, Blood and Tissues
July 2008

Attachment

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Regulation of hypoxic therapy and altitude training devices in Australia (pdf,278kb)