Global SaMD Harmonisation Advances Under Taiwan’s Continued Leadership

Taiwan continues to reinforce its position in global medical device regulation, as the Taiwan Food and Drug Administration (TFDA) has been re-elected to chair Working Group 3 (Pre-market: Software as a Medical Device – SaMD) under the Global Harmonisation Working Party (GHWP).

This re-election is more than symbolic. It reflects sustained international confidence in Taiwan’s regulatory expertise, particularly in one of the most dynamic and technically complex areas of medical device regulation: software and AI-driven technologies.

Why This Matters

Software as a Medical Device (SaMD) and AI-enabled medical technologies are reshaping healthcare delivery worldwide. From diagnostic algorithms to remote monitoring platforms, these innovations require robust, adaptive regulatory frameworks that balance innovation with patient safety.

Working Group 3 within GHWP plays a central role in:

• Developing harmonised pre-market approaches for SaMD

• Aligning regulatory expectations across member economies

• Supporting convergence on documentation, clinical evaluation, and lifecycle oversight

Taiwan’s continued leadership in this group positions it at the forefront of shaping how emerging digital health technologies are evaluated globally.

A Signal of Regulatory Maturity

Taiwan has steadily built a reputation as a forward-looking regulator in digital health. The TFDA has been active in:

• Advancing regulatory science for AI/ML-based devices

• Participating in international harmonisation platforms

• Contributing technical expertise to global guidance development

  
  

Being re-elected as Chair signals:

• Recognition of Taiwan’s regulatory competence

• Trust from international counterparts

• A strategic role in influencing future SaMD regulatory standards

  
  

Implications for Industry

For manufacturers developing software-driven or AI-enabled medical devices, this development is significant.

Greater harmonisation under GHWP could mean:

• More predictable regulatory pathways

• Reduced duplication across markets

• Stronger alignment of documentation requirements

• Improved global market access strategies

Companies operating in Asia or targeting multiple GHWP member economies should closely monitor future guidance from Working Group 3.

The Bigger Picture

As digital health innovation accelerates, regulatory leadership becomes a competitive advantage not only for individual companies, but for national ecosystems.

Taiwan’s re-election underscores an important shift: Asia is not only adopting global regulatory standards, but it is actively shaping them.

At ARQon, we continue to monitor developments in international harmonisation and digital health regulation to support informed, forward-looking regulatory strategies.