The Medical Device Authority (MDA) released an announcement on 31 May 2024 about the revocation of the MDA Circular Letter No.1/2022 effective on 23 February 2024, which previously allowed an exemption for the compliance assessment process by the Compliance Assessment Body (CAB) for the COVID-19 test kit registration.
Therefore, all manufacturers or responsible persons must comply with the registration requirements for the registration of the COVID-19 test kit as stipulated under Schedule 3 of Medical Device Regulation 2012 and MDA/GL/IVD-1 - Guidelines How To Apply for In-Vitro Diagnostic (IVD) Medical Device Registration under Medical Device Act 2012 (Act 737).
Now, COVID-19 test kits are required to undergo a compliance assessment process by the CAB through either of the following procedures:
Verification
Applicable for COVID-19 test kits that have approvals from reference countries (US, EU, UK, Canada, Australia, and Japan. May refer to full reference countries in the MDA Circular Letter No.2/2014)
Full Compliance Assessment
Applicable for new COVID-19 test kits that any reference countries have not approved
Source: Medical Device Authority (MDA)
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