Regulatory Bulletin for March/April is now available for subscribers

The March/April 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 verification of manufactured Class D IVDs by Notified Bodies in the EU, FDA’s proposed amendments to the Quality System regulation, transition deadlines for implementing Brazil’s new UDI rules, GMP rules in El Salvador, guidance on Ethiopia’s importation rules, the simplified registration route for certain Class A devices in Indonesia, and 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.