indonesia mandatory validation testing for covid19 rapid antigen kits

Indonesia mandatory testing for Covid-19 Antigen Rapid Diagnostic Tests

Indonesia’s Ministry of Health issued an announcement on 22 April 2021 concerning validation testing of Covid-19 Antigen Rapid Diagnostic Tests.

In order to improve the safety, quality and efficacy of Covid-19 Antigen Rapid Diagnostic Testing (RDT-Ag) products, it is now mandatory to submit validation test results from at least 1 (one) Testing Laboratory. This applies to all new applications and renewals of registration for both domestic and imported Covid-19 Antigen RDT products. 

Previously, Rapid Test products required validation testing at the laboratory of the Health Research and Development Agency (Litbangkes) in order to be registered. However, due to the urgent need for such products this requirement was removed as long as application documents were complete including performance test and validation reports, then the Covid-19 Rapid Antigen products could be registered and distributed in Indonesia.

Covid-19 Rapid Antigen testing kits are in demand in Indonesia as the Indonesian government imposed a requirement at the end of 2020 to present results of an Covid-19 Rapid Antigen test for any person who:

  • wishes to travel
  • attend an event
  • visit the Ministry of Health, etc.

The validation testing must be carried out by a Testing Laboratory that has been appointed in accordance with the Decree of the Health Minister of the Republic of Indonesia No. HK.01.07/MENKES/477/2021.

List of appointed Testing Laboratories

The following laboratories have been appointed for validation testing of the Rapid Diagnostic Test Antigen (RDT-Ag):

  1. Medical Faculty Laboratory of University of Indonesia (FK UI)
  2. Medical Faculty Laboratory, Public Health and Nursing University of Gadjah Mada (UGM)
  3. Medical Faculty Laboratory of Airlangga University (UNAIR)
  4. Medical Faculty Laboratory of Andalas University (UNAND)
  5. Medical Faculty Laboratory of Padjadjaran University (UNPAD)
  6. Center for Health Laboratory (BBLK = Balai Besar Laboratorium Kesehatan) Jakarta
  7. Center for Environmental Health Engineering and Disease Control (BBTKLPP = Balai Besar Teknik Kesehatan Lingkungan dan Pengendalian Penyakit) Jakarta.

If you have any queries about registering and validation testing of Covid-19 Antigen Rapid Diagnostic Test kits or our services for medical device registration and representation in Indonesia, please contact us at sales@andamanmed.com

Sign up for our regulatory roundup delivered once a month to your inbox

Scroll to Top