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…
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 163–171 of 229
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…
Updated EUDAMED Timeline for Modules
The European Commission (EC) has published an updated EUDAMED timeline in relation to the roll out of…
MDCG 2020-16 Guidance: Classification Rules for IVDs
The Medical Device Coordination Group (MDCG) has published an update to guidance document MDCG 2020-16 Rev.3 –…
WHO and GMDN Medical Device Collaboration for Communication
The GMDN Agency was established to provide a system that allows an exchange of medical device information for Health Authorities…
MHRA Clinical Investigations Guidance for Medical Devices
The UK has updated its guidance on notifying the Medicines and Healthcare products Regulatory Agency (MHRA) about…
Swissdamed Database Launch: August 2024 Update
Swissmedic has recently announced the first module of the Swissdamed Medical Devices Database will go live on…
MDCG 2021-5 Guidance: Standardization for Medical Devices
As of July 2nd, 2024, MDCG 2021-5 Rev.1 – Guidance on Standardization for Medical Devices, has been…
Showing 163–171 of 229