Medsafe
The new article clarifies the regulatory requirements related to record-keeping and reporting in the context of clinical trials.
MHRA
The article provides an overview of the current reporting requirements for healthcare products allowed to be used for clinical trials.
Swissmedic
The article highlights the key points related to the regulatory requirements for combination studies intended to be carried out in Switzerland.
Hong Kong
The article outlines the key points regarding the classification rules for medical devices in Hong Kong.
Medical Devices
We are excited to announce that RegDesk, the innovative Regulatory Information Management (RIM) platform, has been recognized as a Representative Vendor in the Gartner® Market Guide for Life Sciences Regulatory Information Management. Read the complimentary Market Guide for RIM Solutions report to learn more!
FDA
The new article elaborates further on the submission of use-related risk analyses, and also provides certain examples intended to demonstrate the way the regulatory approach described in the guidance should be applied.
