Singapore and Malaysia initiate 6-month Medical Device Regulatory Reliance Pilot

ASEAN is one of the world’s fastest-growing healthcare markets—but regulatory fragmentation has long slowed device approvals. That’s changing.

From Sept 1, 2025 – Feb 28, 2026, Singapore’s Health Sciences Authority (HSA) and Malaysia’s Medical Device Authority (MDA) are running a 6-month regulatory reliance pilot covering Class B–D devices.

How It Works

• If registered in Singapore (HSA):→ Fast-track entry to Malaysia via abridged CAB review (30 working days) + registration (30 days).

• If registered in Malaysia (MDA):→ Singapore shortens review timelines by up to 30%—saving 2–4 months depending on device class.

Why It Matters

• First concrete demonstration of the AMDD (ASEAN Medical Device Directive) vision.

• Proves that mutual reliance can cut duplication without compromising autonomy.

• Creates a regulatory bridge between two of ASEAN’s most advanced markets.

• Opens the door to faster pathways across Thailand, the Philippines, and others—though each authority remains independent.

Strategic Implications for Manufacturers

• Accelerated time-to-market → earlier revenues and patient access.

• Lower regulatory costs → reduced duplication of dossiers and assessments.

• Regional leverage → Singapore/Malaysia approval as a launchpad for ASEAN.

Acting Now

This is more than policy—it’s execution. Early movers will:

• Secure approvals faster.

• Lock in commercial partners ahead of competitors.

• Establish a stronger ASEAN footprint while the framework evolves.

MedExport Asia

At MedExport Asia, we support companies to:

• Navigate evolving regulatory frameworks.

• Optimize entry sequencing across ASEAN.

• Build commercial partnerships that convert approvals into sales.

Sources: MDA Malaysia, HSA.

Produced by MedExport Asia Co,.Ltd, a consortium of pharmaceutical professionals supporting market access in ASEAN.