Regulatory Bulletin for September/October is now available for subscribers

The September/October 2022 Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation is now available for downloading from our website.

Our Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins are released between issues of the Journal to keep subscribers up-to-date on some of the most important regulatory changes as they happen.

This latest issue looks at topics such as the proposed reclassification of products without an intended medical purpose in the EU, attempts to address issues with Notified Body capacity and device shortages, the updated timeframe for implementation of EUDAMED, Poland’s new fees for medical devices, the US FDA’s updated policy on GUDID compliance for certain devices, Australia’s new guidance on exemption criteria for certain CDSS, fees for the examination/re-examination of files for diagnostic and laboratory reagents supplied as kits in Egypt, Ethiopian guidelines on medical device donations, Korea’s plans for fast-track entry to market for innovative medical technology, and much more.

Regulatory Bulletins are only accessible by current subscribers to the Journal of Medical Device Regulation. If you are a subscriber, you will need to log in to My Account. Once you are logged in, click on JMDR Publications and you will see the new Regulatory Bulletin listed alongside the Journal issues and other subscriber-specific content.