[Press Release, Jun 24, 2020] Ministry of Food and Drug Safety approves emergency use of COVID-19 diagnostic reagents
- Registration Date 2020-08-06
- Hit 1586
[Press Release, Jun 24, 2020 / unofficial translation]
Ministry of Food and Drug Safety approves emergency use of COVID-19 diagnostic reagents
- To be used for testing of quick screening (exclusion) of emergency patients -
□ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) has approved the emergency use of the three COVID-19 diagnostic reagents requested by the Korea Centers for Disease Control and Prevention for screening emergency patients.
< Diagnostic Reagents Approved for COVID-19 Screening of Emergency Patients >
No. / Manufacturer or Importer / Company Name / Product Name
1. Manufacturer / SML Genetree / Ezplex SARS-CoV-2 FAST Kit
2. Manufacturer / BioSewoom / Real-Q Direct SARS-CoV-2 Detection Kit
3. Manufacturer / LabGenomics / LabGunTM COVID-19 Fast RT-PCR Kit
○ The decision was the first result of the review of 13 products which had responded to the Korea Centers for Disease Control and Prevention’s notice (May 11) for receiving the request for the emergency use of diagnostic reagents* for COVID-19 screening of emergency patients.
* Products for emergency use (emergency patients) that takes less than one hour from pre-treatment of samples to getting results
○ Under the “emergency use approval system,” the Minister of Food and Drug Safety allows a limited period of time the manufacturing, sale and use of diagnostic reagents requested by the central administrative agency when there is an urgent need for diagnostic reagents due to the fear of the pandemic, but there is no authorized product in Korea or the supply of approved medical devices is or is expected to be insufficient.
- The Ministry of Food and Drug Safety approved the emergency use of the products by evaluating the accuracy of diagnosis through examination of their performance data and expert review.
※ Relevant statutes: Article 46-2 of the 「Medical Devices Act」 and Article 13-2 of the Enforcement Decree of the same act
□ The Ministry of Food and Drug Safety expects that the approval of the emergency diagnostic reagents will help establish a rapid diagnostic system by preventing delays in dealing with emergency patients.
○ The remaining 10 products whose review was requested by the Korea Centers for Disease Control and Prevention will be evaluated quickly and qualified products will be approved for emergency use (authorization exemption).
Ministry of Food and Drug Safety approves emergency use of COVID-19 diagnostic reagents
- To be used for testing of quick screening (exclusion) of emergency patients -
□ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) has approved the emergency use of the three COVID-19 diagnostic reagents requested by the Korea Centers for Disease Control and Prevention for screening emergency patients.
< Diagnostic Reagents Approved for COVID-19 Screening of Emergency Patients >
No. / Manufacturer or Importer / Company Name / Product Name
1. Manufacturer / SML Genetree / Ezplex SARS-CoV-2 FAST Kit
2. Manufacturer / BioSewoom / Real-Q Direct SARS-CoV-2 Detection Kit
3. Manufacturer / LabGenomics / LabGunTM COVID-19 Fast RT-PCR Kit
○ The decision was the first result of the review of 13 products which had responded to the Korea Centers for Disease Control and Prevention’s notice (May 11) for receiving the request for the emergency use of diagnostic reagents* for COVID-19 screening of emergency patients.
* Products for emergency use (emergency patients) that takes less than one hour from pre-treatment of samples to getting results
○ Under the “emergency use approval system,” the Minister of Food and Drug Safety allows a limited period of time the manufacturing, sale and use of diagnostic reagents requested by the central administrative agency when there is an urgent need for diagnostic reagents due to the fear of the pandemic, but there is no authorized product in Korea or the supply of approved medical devices is or is expected to be insufficient.
- The Ministry of Food and Drug Safety approved the emergency use of the products by evaluating the accuracy of diagnosis through examination of their performance data and expert review.
※ Relevant statutes: Article 46-2 of the 「Medical Devices Act」 and Article 13-2 of the Enforcement Decree of the same act
□ The Ministry of Food and Drug Safety expects that the approval of the emergency diagnostic reagents will help establish a rapid diagnostic system by preventing delays in dealing with emergency patients.
○ The remaining 10 products whose review was requested by the Korea Centers for Disease Control and Prevention will be evaluated quickly and qualified products will be approved for emergency use (authorization exemption).
Division 국제협력담당관
Written by 배성명
Telephone 043-719-1559