Regulatory Bulletin for December 2022/January 2023 is now available for subscribers

The December 2022/January 2023 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 Czech Republic’s new Act No. 375/2022 Coll. on medical devices and IVDs, Common Specifications for products without an intended medical purpose listed in Annex XVI to the EU MDR, the growing support for amendments to the EU MDR transition periods, clarification on the use of Article 97 to allow certain legacy devices to remain on the market with expired MDD/AIMDD certificates, Health Canada’s new guidance on clinical evidence requirements for medical devices, proposed updates to the US FDA’s breakthrough devices guidance, FAQs on the end of the US FDA’s UDI enforcement policy and UPC alternatives, ANVISA’s updated Regulatory Agenda for 2023, registration of Authorised Representatives with Bahrain’s NHRA, the new Chinese medical electrical equipment standards, guidance on notification of custom-made medical devices in Malaysia, and proposed changes to fees and Unique Device Identification requirements in Taiwan.

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.