How to determine if product is a Medical Device in Australia

A

anamensis

#1
This might sound like a very silly question, but how do you determine whether a product is a medical device in Australia?

I know there?s the definition of what a medical device is, but is there a flowchart available like the ones for US FDA or for CE Mark in Europe?

I was thinking of using the Australian medical device definition and the CE mark flowchart of determining whether a product is a medical device, only because EU and Australia have Mutual Recognition Agreement (MRA) between them (but I?m not sure if it?s right for me to do so).

Currently the product I?d like to define is identified as a non-medical device product, and has CE marking.

Any help would be greatly appreciated.

Thanks,
A.B.
 
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Ronen E

Problem Solver
Staff member
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#2
Re: How to determine if product is medical device in Australia?

Find the differences:

EC MDD:

‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
Australian TG Act:

A medical device is:
a. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
i. diagnosis, prevention, monitoring, treatment or alleviation of disease;
ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
iii. investigation, replacement or modification of the anatomy or of a physiological process;
iv. control of conception;
v. and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or
aa. any instrument, apparatus, appliance, material or other article specified under subsection (2A); or
ab. any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or
b. an accessory to such an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab).
I am not aware of an assisting flowchart published by the TGA.

Cheers,
Ronen.
 
Last edited:
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