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PHILIPPINES: PFDA Released Draft Documents regarding IVD regulation– February 2022

PHILIPPINES: PFDA Released Draft Documents regarding IVD regulation– February 2022

  • 2022-02-18 08:32:17

PFDA released draft document of the updated guidelines for in-vitro diagnostic medical devices (IVD) certification. This new regulation will conform to the risk-based classification of the ASEAN medical device directive (AMDD). A tentative list of registrable IVDs together with a revised set of requirements to register COVID-19 Test Kits was also released on a separate document.

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AUSTRALIA:  Auditing of Medical Device Applications, including IVD Medical Devices – February, 2022

AUSTRALIA: Auditing of Medical Device Applications, including IVD Medical Devices – February, 2022

  • 2022-02-18 07:40:24

Application audit may be conducted during the procedure of inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG). In some applications, audit may be selective under the legislation, however, others may be selected for an audit at the discretion of the delegate. Here we list out the devices that require mandatory auditing under Regulation 5.3. To conclude, a summarised view of the audit process will be provided.

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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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