Asia
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
North America
The article provides additional details regarding the approach to be applied with respect to certain types of medical devices in terms of regulatory flexibility. Table of Contents Introduction The Food and Drug Administration (FDA), a Philippines regulatory agency in...
Saudi Arabia
The article highlights the aspects related to the regulatory status of the changes related to medical devices allowed for marketing and use in the country. Table of Contents The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of...
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...
