​The GHWP Chaired by the Kingdom Prepares Requirements for "COVID-19" Personal Protective Equipment (PPE)

4/8/2020
 
The Global Harmonization Working Party (GHWP) chaired by Saudi Food and Drug Authority (SFDA) has worked with member authorities to established the requirements for personal protective equipment (PPE) such as medical masks, gloves and sterilizers since the outbreak of COVID-19 in China.
Eng. Ali Al dalaan, Vice Executive President for Medical Devices Sector at SFDA and Chairman of the GHWP said "With continued cooperation chaired by SFDA with regulatory agencies, it was agreed to issue an Emergency Use Authorization (EUA) for Coronavirus (PCR + rapid Test) because these devices require time to research and to discover the technical and clinical information for approving the laboratory reagents. The Authority proposed this Emergency Use Authorization, which is now being applied at a global level."
SFDA responds to this stage and helps the private sector through Emergency Use Authorization, in order to maintain the quality and safety of the product and provides an opportunity to access Coronavirus products to the Kingdom to be evaluated and registered after the end of this pandemic.
The Global Harmonization Working Party (GHWP) is one of the largest parties in the world, which specialized in global harmonization for medical devices. Additionally, it includes 31 countries; the most prominent countries are Saudi Arabia, China, Singapore, Malaysia, South Korea, Kazakhstan, South Africa and Chile.