New Swissmedic Database for Economic Operators and Devices
The Swissmedic database, swissdamed, is a new platform for the registration of economic operators and medical devices, including In Vitro…
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 217–225 of 689
MHRA 60 Day Notice Rule for UKCA/CE Marking
If you need to perform a clinical investigation in order to obtain UKCA/CE/CE UKNI marking for your device, the MHRA…
EU Renews UDI Issuing Entities for Medical Devices (2024-2029)
On July 30th, 2024, the European Commission implemented Decision (EU) 2024/2120 regarding the renewal of issuing entities…
Medical Device Registration in Egypt
Egypt is an attractive market for medical device manufacturers, but navigating the specific requirements for medical device registration in…
TGA Draft Guidance and Essential Principle 13B Updates
The TGA released updates on two important guidances. The first is a draft guidance consolidating various documents to assist with…
EU Releases New Template for Notified Body Confirmation Letter
The European Commission has released a new template for the notified body confirmation letter, a critical document outlining the…
CDSCO Post Approval Changes in Medical Devices
India’s Central Drugs Standard Control Organization (CDSCO) mandates that any modifications to medical devices post-approval, such as changes in…
EU Regulation 2024/1860: Key Changes for IVDR Compliance
New regulation amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR): Regulation (EU) 2024/1860: Gradual roll-out of EUDAMED, the obligation…
Regulation (EU) 2024/1860: IVDR Extended Transition Periods
The publication of this Q&A is intended to assist manufacturers and other economic operators in understanding the…
Showing 217–225 of 689