The Medical Device Authority (MDA) has announced the revocation of Circular Letter No. 1/2022, which exempted the compliance assessment process by Conformity Assessment Bodies (CAB) for the registration of COVID-19 test kits under the Medical Device Act 2012.
Effective February 23, 2024, COVID-19 test kit registration must adhere to the procedures outlined in the MDA/GL/IVD-1 Guidelines on How to Apply for In-Vitro Diagnostic (IVD) Medical Device Registration under the Medical Device Act 2012 (Act 737). Registrants must also comply with the registration requirements as stipulated in Schedule 3 of the Medical Device Regulations 2012 and undergo the compliance assessment process by CAB.
This assessment process can occur through either of the following methods:
– Verification for COVID-19 test kits that have received approval from reference countries, namely the US, EU, UK, Canada, Australia, and Japan (Refer to MDA Circular No. 2/2014).
– Full compliance assessment for COVID-19 test kits that have not obtained approval from reference countries.
Further information on this regulation can be accessed here: PEMBATALAN SURAT PEKELILING PIHAK BERKUASA PERANTI PERUBATAN (PBPP) BIL 1/2022: PENGECUALIAN PROSES PENILAIAN PEMATUHAN OLEH BADAN PENILAIAN PEMATUHAN (CAB) BAGI PENDAFTARAN KIT UJIAN COVID-19
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