Have a
regulatory affairs
challenge?
Medical Devices Latest Insights
Curated Regulatory Intelligence Augmented by AI
Medical Devices
ANVISA Published Regulation For Medical Devices
ANVISA issued Resolution 837/2023 on December 15, outlining updated procedures for clinical investigations supporting higher-risk...
Read more
Medical Devices
Rice-Sized Device Tests Brain Tumor’s Drug Responses During Surgery
An NIH-funded team has developed a miniature device with the potential to predict the therapeutic...
Read more
Medical Devices
Brazil CONEP/CNS Publish Guidelines for Ethical Review Exemptions
Brazilian National Commission on Ethics in Research – CONEP/CNS has published on its website a...
Read more
Medical Devices
US FDA Issues Revised Guidance on Qualification of Medical Device Developme…
This final guidance supersedes Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers,...
Read more
Medical Devices
Health Canada Implements ICH Guideline on Nonclinical Biodistribution Consi…
Health Canada has announced the implementation of guideline S12 on nonclinical biodistribution considerations for gene...
Read more
Medical Devices
Clinical trials of Medical Devices – Updates Regarding Ethics Committ…
There have been so many changes in the clinical trial framework in Italy including four...
Read more
Medical Devices
Indonesia Published News about Filling in Medical Device Dictionary Data
Ministry of Health (MOH) Indonesia published news about Filling in Medical Device Dictionary Data. ...
Read more
Medical Devices
Taiwan Published Guidelines for Decentralized Measures for the Implementati…
Taiwan Food and Drug Administration published Guidelines for Decentralized Measures for the Implementation of Drug...
Read more
Medical Devices
UK MHRA Published Guidance on Software as a Medical Device
UK’s MHRA announced the Software and AI as a Medical Device Change Programme last year...
Read more
Medical Devices
Italy Publishes News Regarding Q&A Document on Clinical Trials Facilita…
The Italian Medicines Agency (AIFA) recently published news regarding a new document ‘Questions & Answers...
Read more