IVD Medical Device Registration Service
Andaman Medical specializes in the registration of in-vitro diagnostic (IVD) devices across Southeast Asia. Our experienced team can help you navigate the complex regulatory landscape to bring your IVD products to key markets including Singapore, Malaysia, Indonesia, the Philippines, Thailand, Vietnam and Cambodia.
IVD Medical Device Registration in Southeast Asia
IVD devices are critical in modern healthcare, enabling early disease detection, monitoring, and management. As the demand for innovative diagnostic solutions grows in Southeast Asia, understanding the regulatory landscape for IVD device registration becomes increasingly important for manufacturers seeking to enter the market.
Indonesia
Indonesia
- 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
Malaysia
Malaysia
- 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
Vietnam
Vietnam
- 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
Thailand
Thailand
- 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
Philippines
Philippines
- 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
Singapore
Singapore
- 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
Cambodia
Cambodia
- 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
How Andaman Medical Can Help With Your IVD Registration
Our in-house team of seasoned regulatory affairs specialists is dedicated to ensuring your IVD products meet all necessary regulatory requirements efficiently. We’ll help you with:
IVD classification and applicable regulatory requirements
Preparation and submission of registration dossiers
Management of registration timelines and health authority interactions
Authorised representation and licence holding services
Importation, customs clearance and logistics support
Why Choose Andaman Medical?
Get Expert Help Today
Contact us today to discuss how Andaman Medical can be your trusted partner for IVD registration and market access in Southeast Asia. Our experienced team is ready to help you achieve your commercial goals in this dynamic, fast-growing region.
