According to MDA’s guideline MDA/GL/MD-01 and MDA/GL/IVD-1, all registration applications shall be submitted via the Medical Device Centralized Online Application System (MeDC@St 2.0). There are two scenarios explained in the guideline applicable to COVID-19 test kits and assays only. The registration for COVID-19 test kits and assays does not require assessment from the Conformity Assessment Bodies (CAB). This is thus different from the usual registration route. To ensure the performance of these test kits, MDA has appointed the Local Assigned Evaluation Laboratories to verify the kits. There are two types of scenarios which are elaborated as follows:

  1. 1. SCENARIO (A) is applicable for the COVID-19 test kits which have been recommended for use under special access or conditional approval.
  2. 2. SCENARIO (B) The COVID-19 test kits that are not listed in the MDA portal, those applications are considered as new applications.

Both scenarios (a) and (b) require the establishment license. For scenario (a), the application is accompanied by the technical documents (including Conditional Approval Letter/ Special Access Notification) to register the COVID-19 test kits.

In the event of a disagreement or the necessity for expert input in Scenario (b), an expert committee will be held. If additional information or documents are required, MDA will return the application to the applicant. Once the applicant complies with all requirements and MDA is satisfied, MDA will email  the Evaluation Letter for the application to be evaluated at an assigned testing facility. MDA emails the application the Recommended for Use or Not Recommended for Use letter after receiving the evaluation report from the testing facility.

The detailed procedure on how to register the COVID 19 IVD Test Kits can be found here; Guideline for Registration of Covid-19 IVD Test Kits



Guideline for Registration of Covid-19 IVD Test Kits