In Vitro Diagnostic Device (IVD)
The purpose of this page is to provide a brief introduction to the medical device known as an IVD and also to mention briefly the Australian Register of Therapeutic Goods (ARTG) and the Regulations in relation to it.
The phrase “in vitro” is actually Latin, meaning “within glass”, which is where the IVD derives it’s name. An IVD is in essence, any medical device that contains a reagent and / or instrument for measuring human specimens, such as blood. Of course, this covers a very wide range of devices, however, for the purpose of our explanation, a medical device that measures say blood glucose levels, is an IVD. The same goes for devices that measure cholesterol, uric acid and hemoglobin blood levels. The EasyMate range of products are IVD’s. You can read more about this subject in Wikipedia.
Many people get confused about the measuring scale used in these devices and the accepted scale in Australia is millimoles/liter and this is abbreviated to mmol/l. A number of other countries (usually those using metric) also use this scale of measurement. Some countries, like the USA use a scale of milligrams/deciliter, which is abbreviated to mg/dl. What makes this all rather confusing, is that a lot of literature mentions one or the other of these scales, but doesn’t always provide you with both scales. The EasyMate meters do provide a readout in mmol/l, which is the Australian standard, however both scales are provided in the instructions, when the accepted normal range is referred to.
The ARTG:
The Therapeutic Goods Administration is the regulatory body for all medical devices (and medicines) in Australia and they assess that these types of goods are of an acceptable standard. Broadly, therapeutic goods must be entered in The ARTG (Australian Register of Therapeutic Goods), before they can legally be supplied in Australia. The EasyMate range of IVD’s is listed in the ARTG and the Numbers are stated on our Products page. Members of the public can search the ARTG if they wish to do so and this database can be searched by you at the ARTG.
By way of background, prior to July 2010, the regulation of IVD’s was very limited, however after this date the new regulatory framework changed considerably, so that all IVD’s are now under a new level of scrutiny. This includes best practice in safety, quality and risk management, as well as a new classification for them. The EasyMate product range was submitted after July 2010, and therefore was subject to the new level of scrutiny within the regulations. This is quite a complex issue and you can read more about by going to the overview of this framework on the TGA website.
One important aspect about the above, is that of self-testing, usually in the home environment without medical supervision, or perhaps a point-of-care situation, where a health professional may be in attendance. The EasyMate range was submitted on this basis and was therefore selected for an application audit. This is a very detailed process and involves submitting a large amount of documentary evidence relating to the product, the manufacturing process, quality control and clinical trials etc. Obviously, the product must meet all the relevant essential principals, otherwise it could not get listed in the Register. The Easymate application to be included in the Register (ARTG) was successful in regards to the above.
Having said all of the above, it is important to mention that there are a number of ongoing responsibilities in regards to the ARTG listing and these include ongoing monitoring for safety, quality and performance, as well as complying with the various regulatory guidelines. We are confident that the EasyMate product range will meet these responsibilities and we hope that this brief explanation has been of assistance to you in understanding the process.