- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
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ANDAMAN MEDICAL PTE LTD (Head Office Singapore)
Tampines Junction Business Center
Level 09-02, 300 Tampines Avenue 5,
Singapore 529653