• 2022-01-26 08:15:53

TGA has already implemented reforms to the regulation of software-based medical devices from 25 February 2021. Under the new regulation, some software may be excluded from the TGA regulations, or although still regulated by TGA they may be exempted from the need to include the product in the ARTG. In the following, we gathered some FAQs and have summarised TGA’s article to help you have an insight on what is required to operate legally in Australia.

• 2022-01-26 04:00:20

Despite it being a criminal offense to import, supply or export medical devices that do not meet the EPSP, there may be extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time. TGA Australia grants exemption in certain situations. Here we gather some FAQs related to the application of the consent for non-compliance of the medical devices and summarize this article in order to help you understand what you need to know for the condition and application.

• 2021-12-27 02:04:41

TGA regulates all medical devices that are for introduction into the body as Class IIa (low-medium risk) or Class IIb (medium-high risk) devices. Transitional arrangements are in place to ensure that manufacturers can continue to supply their previously registered devices while they apply for them to be included in the ARTG in accordance with the new classification.

• 2021-12-27 01:30:53

TGA has introduced a new definition for custom-made medical devices. The impact of the new definition is the majority of devices previously supplied under the exemption for custom-made medical devices no longer meet the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG) if they are being supplied in volumes of more than five per financial year.

• 2021-11-24 10:22:35

2021 saw some new regulations being introduced by the TGA, especially on reclassified medical devices, software and increased effort on safe post market vigilance. Let’s take a look at what awaits the Australia medical device regulatory landscape in 2022.

• 2021-09-29 00:29:09

The TGA has recently published a guidance document of an overview for patient information materials. The patient information materials consist of patient information leaflets (PIL) and patient implant cards (PIC), for implantable medical devices and active implantable devices. From December 1st, 2021, all implantable or active implantable devices will require patient implant cards and patient information leaflets, unless they are specifically excluded from these requirements.

• 2021-08-01 15:52:06

The Australian medical device market is mature, with a well-formed regulatory system. With 80% of its medical devices being imported and huge emphasis placed on smart medical devices, let's take a look at this robust market and its regulatory system, in this article.

• 2021-08-01 14:58:32

Australian corporations can apply to become an Australian Conformity Assessment Body (AU CAB) from 01 July 2021. While TGA can designate bodies within Australia to undertake conformity assessment of medical devices, the details and guidance on the process are still being finalized.

• 2021-08-01 14:48:08

TGA's inclusion process for Class I in vitro diagnostic (IVD) medical devices in the Australian Register of Therapeutic Goods (ARTG) changed on 4 December 2020. This follows similar changes made on October 1, 2020, for Class I non-measuring, non-sterile medical devices. This article outlines the key changes about including Class I medical devices and Class 1 IVD medical devices in the ARTG.

• 2021-06-25 10:59:19

Any medical device (unless excluded or exempt under the Therapeutic Goods Act 1989) must be included in the Australian Register of Therapeutic Goods (ARTG) before it can be legally imported into, supplied within, or exported from Australia. This guidance is intended for sponsors applying for the inclusion of a 'kind of medical device', including IVD medical devices, in the ARTG.