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INDONESIA:  New Guidance on Procedures for Withdrawal and Destruction of Non-conforming Medical Devices – July, 2021

INDONESIA: New Guidance on Procedures for Withdrawal and Destruction of Non-conforming Medical Devices – July, 2021

  • 2021-08-01 16:05:20

The Indonesian Ministry of Health has issued new guidance on Withdrawal and Destruction of Non- Conformity Medical Devices. It describes the types, criteria, roles and responsibilities, classifications, and procedures for withdrawing medical devices from circulation. It is hoped to assist manufacturers, importers, and distributors in better managing post-market activities such as the withdrawal of medical devices in Indonesia.

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AUSTRALIA: Changes to ARTG's Inclusion Process for Non-Measuring, Non-Sterile Class I Medical Devices – July, 2021

AUSTRALIA: Changes to ARTG's Inclusion Process for Non-Measuring, Non-Sterile Class I Medical Devices – July, 2021

  • 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.

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AUSTRALIA: Introducing IVD medical devices in the ARTG – June, 2021

AUSTRALIA: Introducing IVD medical devices in the ARTG – June, 2021

  • 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.

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 AUSTRALIA: Regulatory changes for software based medical devices – May, 2021

AUSTRALIA: Regulatory changes for software based medical devices – May, 2021

  • 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.

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