Selling of Medical Power Supply in Australia/New Zealand and Japan

[Roland chung]

Hi all,

I want to know if CB certificate and report based on IEC 60601-1 are sufficient for medical power supply being sold in Australia/New Zealand and Japan.

It seems that both RCM mark (Australia/New Zealand) and PSE mark (Japan) are not applicable when it comes to medical.

Could you shed some light on this? Thanks in advance.

Roland

 

[Ronen E]

Is this power supply considered a medical device or an accessory to a medical device in Australia (the definition is identical to the EC one)?

 

[Roland chung]

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!

 

[Ronen E]

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.

 

[Roland chung]

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.

If so, how should we do?

 

[Ronen E]

If so, how should we do?

(a) Avoid any offer for sale of the power supply stand-alone, or any marketing that may imply such offer; and

(b) Handle the device that the power supply is integrated in according to all the applicable regulations.

Perhaps I'm not properly reading you question