Regulatory Bulletin for June/July is now available for subscribers

The June/July 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 Brazil’s inspection programmes and criteria for granting or renewing GMP certification, medical device and IVD labelling in Ethiopia, the re-registration process and associated fees in Malaysia, demonstrating EMC in US pre-market submissions, the EU’s rules for ‘legacy devices’ under the IVDR, Spain’s temporary rules for communicating the marketing/commissioning of IVDs, Switzerland’s IvDV, Turkey’s alignment with the MDR/IVDR, 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.