Regulatory Bulletin for June / July 2024 is now available for subscribers
The June / July 2024 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 Bulletin looks at the following topics:
- Czech Republic releases new guidance on in-house IVDs
- New EU guidance on the clinical evaluation of orphan medical devices
- Updated guidance clarifies EU regulatory requirements for drug-device combinations
- Italy’s AIFA issues guidance on obtaining a scientific opinion on an ancillary medicinal substance
- UK MHRA proposes framework for international recognition of medical devices
- Enforcement discretion to end for laboratory developed tests in the USA
- Final US guidance issued on the remanufacturing of medical devices
- China’s new IVD reagent ‘Classification Catalogue’ to take effect on 1 January 2025
- Import/manufacturing licence applications for Class C and Class D medical devices in India
- Devices imported from/exported to countries without diplomatic ties with Malaysia
- New Zealand’s ‘Therapeutic Products Act’ to be repealed
- Software and artificial intelligence that are considered medical devices in Thailand
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. If you are not a subscriber, sign up now!
