Use of a "Priority existing chemical" in medical device in Australia


Mike Blanc

Hi All,

I have some questions that need some expertise from Australia folks.

My medical device is going to be registered with TGA and my supplier told us one of the component contains "N-Methyl-2-pyrrolidone" CAS 872-50-4 which is a "Priority existing chemical" under Australia National Industrial Chemicals Notification and Assessment Scheme (NICNAS).

The exposure limit stated in Australia "Safe Work Australia" website are in mg/m3 (airborne).

My questions:
1) Is the Australia NICNAS and Safe Work Australia regulations applicable to medical device?

2) If these regulations are applicable, how can we comply with them? My biocomp study such as extraction and leeching results are in liquid state but the exposure limit is in air state.

Can anyone please advise.


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