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USA: The Medical Device Breakthrough Devices Program in the USA – May, 2022

USA: The Medical Device Breakthrough Devices Program in the USA – May, 2022

  • 2022-05-26 14:17:56

The US FDA offers manufacturers an opportunity to interact with FDA's experts to speed up the necessary processes for breakthrough medical devices to enter the US market. As a result, manufacturers with breakthrough medical devices have several benefits in the premarket review phase and a prioritized submission review.

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China: Announcement on the Issuance of Guidelines for the Preparation of Annual Self-Inspection Reports of the Medical Device Quality Management System (No. 13 of 2022) – May, 2022

China: Announcement on the Issuance of Guidelines for the Preparation of Annual Self-Inspection Reports of the Medical Device Quality Management System (No. 13 of 2022) – May, 2022

  • 2022-05-26 13:11:53

NMPA has organized and revised the “Guidelines for the Compilation of the Annual Self-Inspection Report of Medical Device Quality Management System”, which has been promulgated and shall come into force on May 1, 2022. The Guidelines for the Compiling of the Annual Self-Inspection Report of Quality Management System of Medical Device Manufacturers issued by NMPA (No. 76 of 2016) previously shall be abolished at the same time.

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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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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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