Submitted by admin on Thu, 04/09/2020 - 05:45
Members   EUA Information
Chinese Taipei

List of COVID-19 related EUA on Manufacturing/Import of Medical Device

Kingdom of Saudi    Arabia

List of SFDA Emergency Use Authorization (EUA) and Medical Devices Marketing Authorization for COVID-19 IVD Test Kits

Saudi FDA Regulatory requirements for Emergency Use Authorization (EUA) for IVDD and Personal Protective Equipment (PPE) during the outbreak of COVID-19

New Update

People's Republic of China

1. NMPA gives emergency approvals to COVID-19 test kits

2. Regulatory Requirements and Standards for Coronavirus Reagent Test Kits and Protective
    Equipment in China

Republic of Korea

List of COVID-19 Diagnosic Kits Authorized for Use under Emergency Use Authorizations


 Guidance on expedited approval of COVID-19 Diagnostic Tests - Provisional Authorisation

 HSA’s Regulatory Position on Respiratory Devices: Supply for Management of COVID-19 patients

 Guidance on 3D Printing of Essential Medical Devices and Accessories for Use in COVID-19 Situation