On 1st April 2024, MDA announced that MDA Circular No. 1/2022 has been cancelled with effect from the 23rd of February 2024 in accordance with the decision made in the MDA Member Meeting Bill 1/2024.
According to Circular No. 1/2022, COVID-19 test kits registered under Section 5 of Act 737 for personal or professional use are excluded from the Compliance Assessment Body's (CAB) compliance assessment procedure under Section 7 of the Medical Devices Act 2012 (Act 737). Regarding the cancellation of this circular letter, all applications for the registration of COVID-19 test kits are subject to a compliance assessment procedure conducted by the CAB, which may involve verification or a full compliance assessment in order to meet the requirements for medical device registration.
Test kits that go through the full compliance evaluation process must undergo an evaluation test in a testing laboratory that has the recognition of ISO 15189 – Medical Laboratories, Requirements for Quality and Competence.
The announcement was consistent with the one made on July 14, 2023, regarding the Transition Period for Registration Applications with the Exemption of the Compliance Assessment Process by the Compliance Assessment Body (CAB) to Registration Based on Circular Letter Number 2/2014 for the Registration of COVID-19 Test Kits.
References: