MALAYSIA: MDA REPEALS CIRCULAR EXEMPTING COVID-19 TEST KITS FROM THE COMPLIANCE ASSESSMENT PROCESS - APRIL/MAY 2024
- 2024-05-07 09:28:59
The Medical Device Authority (MDA) announced the cancellation of the Circular exempting the registration of Covid-19 Test Kits from the Compliance Assessment Process by the Compliance Assessment Body (CAB). The MDA Circular No. 1/2022 states the exemption of the compliance assessment process by the Compliance Assessment Body (CAB) under Section 7 of the Medical Devices Act 2012 (Act 737) for the registration of COVID-19 test kits under Section 5 of Act 737 either for self-use or for professional use.
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