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.
More Screening and inspection of the importation of medical devices are being carried out at the main entry points of malaysia. This is one of the mechanisms to curb the activities of importing medical devices without a valid license, registration or authorization.
More 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.
More NMPA, in conjunction with the National Health Commission, has revised the Quality Management Practice for Clinical Trials of Medical Devices, which is hereby promulgated and will take effect from May 1,2022.
Attachment: Quality Management Practice for Clinical Trials of Medical Devices
NMPA made several adjustments to the medical device classification catalogue as summarized below.
More Concerning the rapid development of Artificial Intelligent/Machine Learning-Based SaMD, TFDA has updated the related guidance that was initially announced in 2020. The latest requirements are summarzied in this article.
More 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.
More 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.
More NMPA has released the latest guidelines, which aim to guide registration applicants in the preparation and writing of passive implantable medical device stability research and registration application materials. While it further also provides a reference for the technical review departments.
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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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