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AUSTRALIA: Information for Medical Practitioners on Up-Classification of Surgical Mesh Devices – March 2022

AUSTRALIA: Information for Medical Practitioners on Up-Classification of Surgical Mesh Devices – March 2022

  • 2022-03-25 10:23:24

In December 2018, TGA has announced that there will be an adjustment of Surgical Mesh Devices to transform from medium risk (Class IIb) to high-risk devices (Class III), in order to meet the highest levels of safety, quality and clinical performance.
Sponsors were given three years to comply with the changes, and from 1 December 2021 onwards TGA has already commenced on cancelling surgical mesh devices in the ARTG as Class IIb entries, who do not have obtained an appropriate conformity assessment certificate for Class III devices prior to the set deadline, or within six months of the conformity assessment certificate for the Class III device being issued.
TGA has listed out 3 different tables, categorising meshes that are eligible for transition, approved surgical mesh devices, and existing Class III surgical mesh devices. This is to inform medical practitioners and hospitals of potential supply disruption of some surgical mesh devices from 1st December 2021, and to provide alternative sources of supply.

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USA: FDA Transition Plan for Emergency Use Authorizations (EUAs) Medical Devices – February, 2022

USA: FDA Transition Plan for Emergency Use Authorizations (EUAs) Medical Devices – February, 2022

  • 2022-02-18 09:37:25

The US FDA is planning to issue transition plans for medical devices with Emergency Use Authorizations (EUAs). The EUA measure had previously been implemented in order to increase related necessary medical product supply on the US market.
As the Coronavirus Disease 2019 (COVID-19) pandemic gradually slows down, FDA has published a draft guidance to provide its recommendations to manufacturers, and in order to outline a roadmap for EUA devices to be able to transition after the emergency use declarations are no longer in effect in the future.

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China: Two Guidelines for Registration and Review of Drug-Device Combination Products Mainly Functioning as Medical Devices – February, 2022

China: Two Guidelines for Registration and Review of Drug-Device Combination Products Mainly Functioning as Medical Devices – February, 2022

  • 2022-02-18 08:10:07

Drug-device combination products that mainly function as medical devices (referred to as drug-device combination medical devices in this guideline) are expected to make prevention and treatment of diseases more effective, but may also lead to new technical concerns. Therefore, NMPA formulated two guiding principles to further guide the applicant's preparation for the registration application for drug-device combination medical devices, and to encourage the innovative development of such products.

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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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