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.
MDA Announcement for Transitional Period for Registration COVID-19 Test Kit
Requirement of Covid-19 test kits