Newsletter

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:  TGA Introduces Conformity Assessment Bodies –July, 2021

AUSTRALIA: TGA Introduces Conformity Assessment Bodies –July, 2021

  • 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.

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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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QT Webinar: China Medical Device Registration

QT Webinar: China Medical Device Registration

  • 2021-06-25 08:59:13

Qualtech Consulting would like to invite you to our free online Webinar on the subject of the ”China Medical Device Registration – New Regulation for Supervision and Administration of MDs (RSAMD)”, which has gone into effect on June 1, 2021.

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