• 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.

• 2021-06-25 10:40:40

Medical devices cannot generally be imported, supplied in, or exported from Australia unless they are included in the ARTG (Australian Register of Therapeutic Goods. Only an Australian sponsor can apply to include an IVD (In Vitro Diagnostics) in the ARTG. TGA has now issued requirements to be fulfilled in order to include an IVD in the ARTG.

• 2021-05-22 03:59:29

The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software based medical devices. These regulations commenced on February 25, 2021 for new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG). The clarification of the boundary for software-based products regulated as medical devices in Australia is important to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight. Certain software-based medical devices have been carved out (through either an exemption or exclusion) from the scope of the TGA regulation. The transition period (ending November 1, 2024) applies to sponsors of eligible medical devices already included in the ARTG, or included in the ARTG because of an application lodged before 25 February 2021.

• 2021-04-26 02:39:59

Australia Department of Health (DoH) Therapeutic Goods Administration (TGA) has made some amendments and issued the Therapeutic Goods Amendments (2020 Measures No. 2) Act 2021, focusing on unique device identification (UDI) under Therapeutic Goods Act 1989.