List of Emergency Use Authorization (EUA) of AHWP Member Country/Region

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
http://www.fda.gov.tw/ENG/site.aspx?sid=11194

 Kingdom of Saudi     Arabia


List of SFDA Emergency Use Authorization (EUA) and Medical Devices Marketing Authorization for COVID-19 IVD Test Kits
https://www.sfda.gov.sa/en/medicaldevices/Authorized/Documents/EAUdevices.pdf

Saudi FDA Regulatory requirements for Emergency Use Authorization (EUA) for IVDD and Personal Protective Equipment (PPE) during the outbreak of COVID-19
https://www.sfda.gov.sa/en/medicaldevices/regulations/Documents/SFDA-Efforts-COVID19.pdf

New Update 
https://www.sfda.gov.sa/en/medicaldevices/regulations/Documents/SFDA-International-EffortsEN.pdf

 People's Republic of   China


1. NMPA gives emergency approvals to COVID-19 test kits
http://english.nmpa.gov.cn/2020-03/27/c_465663.htm?from=singlemessage&isappinstalled=0

2. Regulatory Requirements and Standards for Coronavirus Reagent Test Kits and Protective
    Equipment in China
http://english.nmpa.gov.cn/2020-03/30/c_467202.htm

 Republic of Korea


List of COVID-19 Diagnosic Kits Authorized for Use under Emergency Use Authorizations
https://www.mfds.go.kr/eng/brd/m_52/view.do?seq=74424&srchFr=&srchTo=&srchWord=&srch
Tp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

 Singapore

 
 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