Malaysia: New Guidelines for Registration of Covid 19 IVD Covid Test Kits

The Medical Device Centralized Online Application System (MeDc@St.2.0) will be used for submission of all registration applications. Assessment from the Conformity Assessment Bodies (CAB) is no longer required for registration of Covid-19 test kits and assays. Instead, verifications of kits will be done by Local Assigned Evaluation Laboratories to confirm the quality of the test kits.

There are 2 applicable scenarios specifically for COVID 19 test kits and assays in the new guidelines:

Scenario A: Applicable for Covid-19 test kits endorsed under special access or conditional approval.

Scenario B: Applicable for Covid-19 test kits that are not included in the MDA portal and hence regarded as new applications.

Establishment License is necessary for both scenarios.

Source:

Guideline for Registration of Covid-19 IVD Test Kits

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