Bagaimanakah Badan Penilaian Pematuhan (CAB) didaftarkan di Malaysia? | How are Conformity Assessment Bodies (CABs) registered in Malaysia?

CAB didaftarkan oleh Pihak Berkuasa Peranti Perubatan (MDA) berdasarkan kecekapan, kepakaran, dan pematuhan mereka kepada piawaian yang berkaitan. Proses pendaftaran melibatkan penilaian menyeluruh terhadap keupayaan teknikal CAB dan sistem pengurusan kualitinya.

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BAHAGIAN KAWALAN PRA PASARAN (BKPP)
03 - 8230 0376

CABs are registered by the Medical Device Authority (MDA) based on their competence, expertise, and compliance with relevant standards. The registration process involves a thorough assessment of the CAB's technical capabilities and its quality management systems.

For further inquiries, please contact
PRE-MARKET CONTROL DIVISION (BKPP)
03 - 8230 0376