Thailand
The new article highlights the aspects related to management review, as well as the requirements for personnel, premises, and cleanliness as set forth by the draft regulation on criteria and good methods for distributing medical devices. Table of Contents The Thai...
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...
FDA
The new article describes the aspects related to the use of electronic form in certain aspects associated with clinical trials. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
Saudi Arabia
The new article describes in detail the regulatory approach the authority intends to apply with respect to x-ray equipment in terms of assembly in order to ensure the safety and proper operations of the devices. Table of Contents The Food and Drug Administration (FDA...
FDA
The article covers the key points related to the existing regulatory requirements and highlights the most important aspects to be considered by the parties involved. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
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...
