Australian Therapeutic Goods Administration (TGA) requirements for Electromedical Devices

 

Electromedical devices are powered by electricity—mains, battery and low-powered devices. Examples are pacemakers, pulse oximeters, and blood-pressure monitors.

 

There are potential safety risks to the patient and/or user if the medical device:

· causes the patient and/or user unintended exposure to electrical currents

· interferes with or affects another electromedical device—Electromagnetic Compatibility (EMC).

 

To ensure that manufacturers of electromedical devices have considered these risks they must demonstrate compliance with:

 

· Essential Principle 9.2—Minimisation of risks associated with use of medical devices

· Essential Principle 12—Medical devices connected to or equipped with an energy source.

 

The most common way to demonstrate compliance is to meet a standard published by an Australian or international standards agency, or a similar standard. If the manufacturer chooses to use other voluntary standards they must provide evidence that the chosen standard is applicable to the manufacturer's device and that its application satisfies the requirements of the Regulations.

 

Several AS/NZS, EN and IEC standards may be used to demonstrate compliance.

 

 

  Compliance Solutions

 Medical Devices

 

 

Phone: 03 9329 0159

Fax: 03 9399 1303

Email: compliance@emcsi.com.au

 

 

 

We assist our clients in their preparation of the technical file that must be submitted to the TGA.  We undertake the risk assessment against the TGA’s requirements and prepare all the reports required to demonstrate that compliance has been achieved for electromedical devices.  This includes electrical safety and EMC.

 

For those clients who want to export their product to the EU we address the requirements as set down in the Medical Devices Directive including protection against:

 

· Electrical risks

· Mechanical and thermal risks

· Vibration

· Noise

· Temperature

· EM fields