December’s Regulatory Bulletin is now available

The December 2021 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 month’s issue looks at topics such as GMP certificates in Argentina, use of GTIN barcodes in Egypt, proposed easing of ISO 13485 requirements in India, US recommended pre-market submission documentation for device software functions, EU rules for electronic instructions for use, 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.