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_65/list.do 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
