- 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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Welcome to Andaman Medical. We are your trusted partner for regulatory affairs and market access in Southeast Asia.
Whether you are a medical device manufacturer or distributor, our dedicated team is here to help you navigate the complex regulatory landscape and bring your products to market efficiently and compliantly.
Whether you are a medical device manufacturer or distributor, our dedicated team is here to help you navigate the complex regulatory landscape and bring your products to market efficiently and compliantly.
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ANDAMAN MEDICAL PTE LTD (Registration no. 201524804D)
(Head Office Singapore)
Tampines Junction Business Center Level
09-02, 300 Tampines Avenue 5, Singapore 529653
ANDAMAN MEDICAL PTE LTD
(Head Office Singapore)
Tampines Junction Business Center Level
09-02, 300 Tampines Avenue 5, Singapore 529653
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