What We Assess
Our auditors evaluate quality management systems across the complete medical device lifecycle, including post-market surveillance and regulatory compliance. They performed witnessed assessments of Singapore Accreditation Council (SAC) accredited certification bodies and independent compliance audits of local manufacturers, importers and wholesalers. These assessments are essential for maintaining the integrity of the medical device supply chain and ensuring the continued safety of medical devices in Singapore.
MEDICAL DEVICE QUALITY SYSTEMS, ADVERSE EVENTS AND COMPLIANCE BRANCH (QACB)
Deputy Director
Ms TAN Yuhua
Senior Assistant Director
Ms SIEW Jie Yee
Regulatory Consultant
Dr Debbie KO
Senior Regulatory Specialist
Ms Amritamayee SAHOO
Senior Regulatory Specialist
Ms CHIA Yen Yen
Senior Regulatory Specialist
Mr CHIN Ching Siang
Senior Regulatory Specialist
Dr Shaqireen MOINUDDEEN
Senior Regulatory Specialist
Dr ZHONG Yanxin
Regulatory Manager
Mr TEO Tee Yuan