Regulatory Bulletin for June / July 2023 is now available for subscribers
The June / July 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 Bulletin looks at the following topics:
- Creation of regulatory agency for medicines and medical devices for Latin America and the Caribbean
- ‘Supplement for Medical Devices 5.0’ to the Mexican Pharmacopoeia now available
- Amendment of transitional provisions for EU common specifications for products without an intended medical purpose
- Four Italian Decrees published concerning clinical investigations of medical devices
- Update on implementation of the future UK regulations and continued acceptance of CE marked devices
- Final guidance published in USA on content of pre-market submissions for device software functions
- Australia confirms that EU MDR transition extensions will be recognised
- Ethiopia issues new guideline on the medical product special import permit system
- Hong Kong Department of Health to prioritise procurement of MDACS listed devices
- Japan publishes new guidance on remanufactured single-use devices and software
- Electronic medical device registration certificates are now being issued in Malaysia
- Singapore proposes updates to guidance on risk classification of IVDs
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!
