The power supply is not medical device in its own right, but a component of medical device. I have no idea if medical power supply will be regulated by TGA.
Someone told me that medical power supply needs RCM mark, but 60601-1 is not included in the standards list for RCM. VERY confusing!
Hi,
I think that the power supply will be regulated by the TGA, at least as a Therapeutic Good, because according to the Australian law, Therapeutic Goods are also goods that are
for use as an ingredient or component in the manufacture of therapeutic goods. Medical Devices are Therapeutic Goods, so a Medical Device's component would meet that definition.
This
ACMA page clarifies the Medical Devices exemptions from the general requirements under ACMA; however, according to your statement "The power supply is not medical device in its own right, but a component of medical device", it may be a little harder to satisfy the authorities that these exemptions apply. Anyway the exemptions are only partial so it may still require additional testing and labelling on top of the TGA's requirements.
If the power supply is only sold as an already-integrated component of the medical device, I think it should not be looked at as an individual object placed on the market; i.e. your obligations will be covered through meeting the requirements applicable to the medical device in which the power supply is integrated.
Cheers,
Ronen.
