Saudi Arabia
The document highlights the key points associated with the licensing requirements for medical device establishments. Table of Contents The Saudi Food and Drug Authority (SFDA), a country’s regulatory agency in the sphere of healthcare products, has published a...
Asia
The document outlines the key points related to the applicable classification requirements for specific types of medical devices. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of healthcare products, has published a...
FDA
The new article highlights the aspects related to the key considerations related to the study design. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft...
Uncategorized
Medical device compliance is an important aspect of the medical industry that ensures the safety and effectiveness of medical devices. Medical devices range from simple instruments, such as tongue depressors, to complex devices, such as implantable defibrillators. ...
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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