According to Number Circular 2/2014, the medical device in which including the COVID-19 test kit assessment during an epidemic/pandemic will now proceed to the registration phase.
After July 31, 2023, the method given in MDA/GL/07, Guideline for Registration of COVID-19 IVD Test Kits is no longer accepted by MDA. Therefore, a conformity assessment body (CAB) must evaluate each application for registration of a COVID-19 test kit through a Verification or Full Assessment process.
A COVID-19 test kit that is subjected to the Full Assessment procedure must undergo an evaluation test in a testing laboratory that has received MDA accreditation (ISO 15189 or ISO 17025).
The testing laboratory will not get any Evaluation Letters from MDA.