Medical Device Compliance Consultancy

Medical Device 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. Here is where Andaman Medical comes in.

Our 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. 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.

Our Team Of Experts Can Assist You In:

Indonesia

Medical devices and IVDs are 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

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.

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

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

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

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

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.

How Andaman Medical Helps You Navigate Medical Device (MD) Compliance

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:

Access to a Growing Market

Break into Southeast Asia’s dynamic and rapidly expanding healthcare sector with confidence. At Andaman Medical, we guide you through complex market entry requirements so your medical devices reach the right markets at the right time. Our on-the-ground presence across the region ensures you tap into opportunities in both established and emerging economies.

Regulatory Compliance

Ensure your devices meet the strict regulatory standards of Southeast Asia with expert support. From product classification and registration to quality system audits, we provide end-to-end assistance to keep your business compliant with both local and international regulations.

Enhanced Market Credibility

Enforce your commitment to safety, quality, and reliability. Our proven track record in securing approvals across Southeast Asia strengthens your credibility with healthcare providers, government authorities, and patients, helping your products gain lasting trust and recognition.

Reduced Risk of Legal Penalties

Avoid costly delays, fines, and reputational damage caused by non-compliance. Our in-depth understanding of Southeast Asia’s regulatory frameworks ensures your submissions and approvals are accurate, timely, and legally sound, safeguarding your business every step of the way.

Faster Market Entry and Expansion

Speed is crucial in the competitive MedTech industry. With our extensive regulatory expertise and strong relationships with local authorities, Andaman Medical helps you accelerate approvals and expand across multiple Southeast Asian markets without unnecessary setbacks.

Improved Patient Access and Outcomes

Every medical device we help bring to market has the potential to improve lives. By ensuring regulatory compliance and efficient entry into Southeast Asia, we connect innovative medical technologies with patients who need them most, driving better health outcomes across the region.

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.