FDA
The article provides an overview of the regulatory requirements set forth under the existing framework and highlights the key points associated thereto. Table of Contents The FDA, the US healthcare product regulatory authority, has released a guidance document...
Uncategorized
This blog highlights the importance of regulatory compliance for medical device manufacturers, roadblocks and key steps to navigate through them. Table Of Contents: Medical devices play a crucial role in the healthcare ecosystem, aiding in the diagnosis, treatment,...
China
The new article describes in detail the approach to be applied with respect to documentation related to informed consent. Table of Contents Class II medical devices are an important segment of the medical device industry.These moderate-risk devices include many...
FDA
The article addresses the aspects related to the approach medical device manufacturers should apply when assessing the actual performance of their products placed on the market in the context of the Voluntary Improvement Program. Table of Contents The Food and Drug...
BfArM
The new article addresses the aspects related to the directory containing information about any and all digital health applications available in Germany. Table of Contents The German regulating authority in the sphere of healthcare products (BfArM) has published a...
#WednesdayWebinar Join us for our upcoming webinar Global Regulatory Changes to Expect in 2025 January 22, 2025 at 10 AM ET
Register Now
