Medical Device Compliance Consultancy
Andaman Medical’s Medical Device (MD) Compliance Consultancy offers expert guidance through the complex regulations in Southeast Asia, covering markets including Singapore, Malaysia, Indonesia, the Philippines, Thailand, Vietnam, and Cambodia. Our team of experts ensures that your medical devices meet all necessary requirements for market entry and ongoing compliance.
With a deep understanding of local regulations and international standards, Andaman Medical provides tailored support to streamline your product’s journey from development to distribution, minimising risks and accelerating time to market.
With a deep understanding of local regulations and international standards, Andaman Medical provides tailored support to streamline your product’s journey from development to distribution, minimising risks and accelerating time to market.
MD Compliance Consultancy in Southeast Asia
Medical devices are integral to modern healthcare, providing vital solutions that enhance patient care and save lives. As the medical landscape evolves in Southeast Asia, understanding and adhering to the complex regulatory requirements is critical for manufacturers eager to bring their innovations to market. Andaman Medical can help you address compliance challenges so you can focus on delivering innovative medical devices to healthcare providers and patients across the region.
Indonesia
Indonesia
- Medical devices and IVD’s 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 Medical Device Authority (MDA) under Medical Device Act 2012
- 4 risk classes (A-D) per ASEAN Medical Device Directive (AMDD)
- Most IVDs require registration and conformity assessment by MDA-registered CAB except for Class A IVD.
- MDA review timelines 3-6 months based on risk class
Vietnam
Vietnam
- IVDs are regulated as medical devices by the Infrastructure and Medical Devices Administration under the Ministry of Health.
- Classified into 4 risk classes (A-D) per ASEAN MDD
- New Decree 98/2021 rules require a Marketing Authorization Code for all IVDs
- Class A/B IVDs via Declaration route; Class C/D IVDs require full Registration
- Some transition provisions extended to end of 2024
Thailand
Thailand
- IVDs regulated as medical devices by Thai FDA Medical Device Control Division
- Classified into 4 risk categories aligned with ASEAN MDD
- All IVDs require registration via Listing, Notification or Licensing based on risk
- Some high-risk IVDs require local performance testing
- Review timelines vary by risk class and route
Philippines
Philippines
- IVDs regulated by FDA Center for Device Regulation, Radiation Health and Research.
- New IVD regulations drafted in 2022 to align with ASEAN MDD 4 risk classes
- FMC 2014-005 lists the IVDs that need registration; those not listed don’t require it.
- Registrable IVDs must pass performance tests at the National Reference Laboratory, except for blood collection tubes.
- Product approval depends on compliance documents submitted to the Philippine FDA and passing the performance test from the National Reference Laboratory.
Singapore
Singapore
- IVDs are regulated as medical devices by the Health Sciences Authority (HSA)
- Classification into 4 risk classes (A-D) guidelines as per ASEAN MDD
- Most IVDs require registration; Class A IVDs exempted from registration.
HSA review timelines range from 100-310 days depending on risk class and evaluation route
Cambodia
Cambodia
- IVDs are regulated as medical devices by the Ministry of Health (MOH).
- Classification into 4 risk classes based on the ASEAN Medical Device Directive (AMDD).
- All IVDs’s registration application are manually submitted to the Drug Registration Bureau in DDF.
- Final approval is quarterly.
Why Andaman Medical Is Your Ideal Medical Device (MD) Compliance Consultancy
With a deep understanding of both local and international regulations, we provide comprehensive support to ensure your products meet all necessary standards. Here’s what we can do for you:
Ensuring compliance with labelling and packaging regulations
Risk management and assessment services
Preparation of technical files and design dossiers
Conducting compliance audits and gap analysis
Preparation of technical files and design dossiers
Market access strategy and support
Monitor and report on any regulatory changes to ensure ongoing compliance
Why Choose Andaman Medical?
