Regulatory Bulletin for March / April 2023 is now available for subscribers
The March / April 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:
- Transitional provisions of the EU MDR and IVDR are formally amended
- European Commission proposes Master UDI-DI for contact lenses
- EMA launches pilot offering scientific advice for certain high-risk medical devices
- New, mandatory breast implant register established in Italy
- Spain’s new Royal Decree supports implementation of the MDR by specifying national requirements
- Switzerland introduces fee for simplified review of a clinical trial application
- Health Canada creates permanent regulatory framework for COVID-19 medical devices
- New application forms and documentation requirements for implementation of Brazil’s Resolution RDC No. 751/2022
- China revises timeframe for submitting medical device supplementary information
- Certain Class II devices must meet China’s UDI requirements from 1 June 2024
- Malaysia publishes new guidance on notification of custom-made medical devices
- Registration of medical devices in Rwanda now includes IVDs
- Taiwan proposes amendments to the classification of certain medical devices
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.
