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:
Our registration services include
Our registration services include
- Standard IVD Registration
- Abridged IVD Registration
- Special Access IVD Registration
- IVD Registration Renewal
- Change Notification for IVD Products
- IVD Product License Transfer
Our authorized representative services include
Our authorized representative services include
- Acting as liaison with local regulatory authorities
- Monitoring regulatory updates relevant to your product
- Holding licenses on behalf of your company
- Reporting and managing adverse events
- Tracking product alerts and recalls
- Handling customer complaints
Additional support services
Additional support services
- 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 Us
Our expert guidance through the region’s evolving regulatory landscape ensures your product remains compliant, allowing you to bring your products to market efficiently and effectively.
Why Choose Andaman Medical?
Our expert guidance through the region's evolving regulatory landscape ensures your product remains compliant, allowing you to bring your products to market efficiently and effectively.
Experienced In-house Team
across 7 Southeast Asian Countries
Full Control with Seamless
Distributor Switching
Singular Point of Contact
for Registration
WHAT MAKES ANDAMAN MEDICAL UNIQUE
QMS Compliance
ISO 13485 Certified
Overcome Language Barrier
With Multilingual Local Team
One-Stop Access
into Southeast Asia
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Years Experience
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Products Registered
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Happy Clients
Why Choose Andaman Medical?
