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.

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.
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