Asia
The new article describes in detail the process of applying for importation approval for a medical device. Table Of Contents: The National Health Regulatory Authority (NHRA), a Bahrain’s regulatory agency in the sphere of healthcare products, has published a guidance...
COVID-19
The article provides an overview of the key provisions of the draft guidance documents dedicated to neonatal products. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
Asia
The new article highlights the aspects related to approvals for clinical trials, as well as pharmacovigilance practices. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulatory agency in the sphere of healthcare products, has...
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. ...
Uncategorized
Medical devices play a critical role in healthcare by improving the diagnosis, treatment, and prevention of various diseases. As a result, they are subject to strict regulatory requirements aimed at ensuring their safety and effectiveness. However, even with these...
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...
