Consumers Buying Guide: Fetal Dopplers

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Fetal Doppler’s on eBay Australia. Do they meet Australian Safety Standards?

Fetal Doppler’s come in all shapes and sizes and different prices.
Like most products the range is usually expansive and price is determined by supply and demand.
Typically Fetal Doppler’s are priced excessively, however due to modern manufacturing techniques and accelerated ultrasound technology, today’s affordability has seen the practice of using Fetal Doppler’s shift into the domestic market, making it common  practice within the home of expecting parents.

For this reason, eBay enjoys the supply of these medical devices from a number of different sellers.

Its no wonder their popularity is on the increase given the ‘peace of mind’ they bring to expecting parents, what most expecting parents are not aware of however is that Fetal Doppler’s with FHR diagnostic function (LCD Display) are subject to a stringent review process before they are approved for supply in Australia.

Not all Fetal Doppler’s are the same, most sold on eBay are supplied illegally. That is, they have not been approved or registered with Australia’s regulatory body- Dept of Health and Ageing –Therapeutic Goods Administration.

As exclusive distributors and registered suppliers of approved Fetal Doppler’s with the Therapeutic Goods Administration, the purpose of this guide is to educate consumers and to ensure your decision is an informed one. Below are some questions/answers on this topic, if nothing else consider yourself aware.

What does TGA stand for?

Therapeutic Goods Administration

What the TGA does?

The TGA is the government body which overseas and regulates the supply of medical devices medicines - therapeutic products in Australia. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.

Does the TGA classify Fetal Doppler’s as medical devices?

Yes. The TGA classify Fetal Doppler’s with FHR detection (models with LCD readout) as medical devices, as such these types of medical devices must be approved and the seller registered with the TGA in order to supply them 'approved' and legally in Australia.

How do I know if a Fetal Doppler is approved by the TGA?

In order to supply a medical device in Australia, firstly the supplier must be registered with the TGA, the supplier must them submit an application covering the medical devices they wish to supply subject to assessment by the TGA. If and when a product is approved for supply the TGA will issue the supplier with an ARTG No and include the approved application on the ARTG register.

Can ARTG numbers be validated for authenticity?

Yes. You may search the TGA database for approved medical devices on their online register here directly from the TGA website.
If you search for an ARTG No in this database and a registered record of an approved device is not returned then the seller has supplied you with a fake ARTG No. Also watch out for sellers who use the ARTG No of others, simply ask for proof of the registered business name as it appears on the ARTG certificate to avoid this pitfall.

Is it illegal to supply a Fetal Doppler if it has not been approved by the TGA?

Yes , it is illegal to supply an medical device in Australia without approval from the TGA.
Consumers are at risk of purchasing a device which has not undergone the conformity assessment process used to approve or reject a medical device application.

Is it recommended to buy an identical looking Fetal Doppler as one that is TGA approved?

No. One of the reasons all medical devices must be TGA approved is to eliminate and safeguard the risk to consumers where they are exposed by the manufacturing practices involving the  'copying' and 'imitation' production environments. Whilst a Fetal Doppler may look identical, it may have been manufactured by an unapproved, non conforming and unrelated manufacturer.

The seller has plenty of feedback but no ARTG No, does it matter?

Ultimately the decision is yours. Sellers may have plenty of feedback which suggests they are certainly good sellers, but does it make their Fetal Dopplers legal in Australia? No it does not. There are many sellers that have acquired feedback over the years however that does not mean it has been achieved through the supply of certified goods according to the Australian government’s regulations. No ARTG No means you are taking a risk, plain and simple.

Does the TGA recognise medical devices with FDA approval?

The FDA is the U.S. Food and Drug Administration.
The TGA does not recognise the FDA. ‘FDA Approved’ bears no significance whatsoever in Australia.

Why do sellers supply Fetal Doppler’s on eBay illegally?

There are 3 typical reasons. 1. The supplier is simply not aware they are acting illegally and supplying an unverified device to Australian consumers. 2. There are costs associated with registration and having medical devices approved, they avoid undertaking certification to reduce costs, and therefore supply medical devices which may be unsafe to the Australian community favouring their bottom line. This is widely considered extremely unethical and questions are raised about principles and integrity.3.The products which are being supplied to the Australian Market blatantly do not conform and will not pass the conformity assesment review if conducted by the TGA.

Can I report the illegal supply of unapproved Fetal Doppler’s to the regulatory body?

Yes, you may send your complaint to TGA directly from their website. Google 'TGA medical device breach'
You may also raise the issue with eBay or the ACCC.

 


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