Asia
The article provides an overview of the regulatory requirements related to recalls and withdrawals for general and in vitro diagnostic medical devices allowed to be marketed and used in Turkey. Table of Contents The Turkish regulatory agency in the...
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...
Uncategorized
A class II medical device is a device that is intended to be used for a moderate-risk purpose. These devices may not pose the same level of risk as class III devices, but they still require some level of regulatory control to ensure their safety and effectiveness....
Uncategorized
A medical device is a product that is used in the diagnosis, prevention, treatment, or management of a disease or medical condition. They are designed to assist healthcare professionals in their work and can range from simple instruments, such as a thermometer, to...
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