Feb 17, 2023
FDA
The article provides an overview of the performance goals related to the applications under the premarket approval framework. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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Feb 17, 2023
FDA
The article provides a general overview of the approach to be applied with respect to the review clock in the context of applications for marketing approval. The document also describes the main regulatory actions to be taken by the authority based on the application...
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Feb 15, 2023
Uncategorized
Over the past few decades, there has been a significant evolution in medical devices in the healthcare industry. Medical devices are an important aspect of healthcare as they help diagnose, monitor, and treat a wide range of medical conditions. These devices include...
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Feb 15, 2023
FDA
A Class 1 medical device is a type of medical device that poses a minimal potential for harm to the user and is generally considered to be low-risk.Class 1 medical devices include a wide range of products, such as bandages, crutches, elastic bandages, and orthopedic...
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Feb 15, 2023
China
A Class III medical device is a device that is intended for use in the diagnosis, cure, treatment, or prevention of disease and is also intended to affect the structure or any function of the body. These devices are generally the most complex and pose the greatest...
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