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THAILAND: Thai FDA released Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device – April, 2022

THAILAND: Thai FDA released Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device – April, 2022

  • 2022-04-27 11:27:43

In correspondence with the risk-classification implementation for recent period starting from mid-February 2021 onwards, Thailand Food and Drug Administration has ultimately publicized the Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device, which has been effective since 1st March 2022.

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JAPAN:  Q&A for Complying with the New QMS Ordinance -Part 4 – April, 2022

JAPAN: Q&A for Complying with the New QMS Ordinance -Part 4 – April, 2022

  • 2022-04-27 11:22:13

On March 4th, 2022, the Japanese Ministry of Health, Labor and Welfare issued a summary of the Q&A related to the New QMS Ordinance. This notice clears frequent questions and gives related manufacturers/manufacturing authorization holders a more detailed idea on how to be prepared for the new QMS regulation.

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China: Guidelines for Medical Device Cybersecurity, Medical Device Software, and AI Medical Device Registration  (Revised Edition 2022)

China: Guidelines for Medical Device Cybersecurity, Medical Device Software, and AI Medical Device Registration (Revised Edition 2022)

  • 2022-04-27 11:16:17

NMPA has released a series of updated guidelines, which aim to guide registration applicants to prepare for medical device software and AI medical device registration in China. The 3 new guidelines regulate the technical reviewing requirements of medical device software and AI medical devices, while also elaborating on standardizing the cyber-security for medical devices.

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3D Printing Revolution in the Medical Device Industry

3D Printing Revolution in the Medical Device Industry

  • 2022-03-28 07:46:30

In the last decade, 3D printing has had a profound impact on the medical device sector. When the COVID-19 pandemic hit, this technology was lauded for its ability to adapt new designs and the speed with which it could produce the necessary commodities. Medical 3D-printed gadgets have a bright future, and we will go through the latest advances and how regulatory bodies across the world are keeping up with this development.

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