Malaysia: MDA Strengthens Engagement with Industry on Innovation & Regulatory Pathways

On 22 September 2025, the Medical Device Authority (MDA) led a key stakeholder engagement session with the Association of Malaysian Medical Industries (AMMI) in Penang, held at the Iconic Marjorie Hotel.

The session, attended by 51 industry participants, focused on strategic discussions regarding regulatory sandboxes for high-tech medical devices, particularly AI-enabled medical devices, and the Medical Device Single Audit Program (MDSAP). These focus areas reflect MDA’s proactive commitment to supporting innovation while maintaining robust regulatory oversight.

Key Highlights from the Session

1. Regulatory Sandbox for High-Tech Devices

During the meeting, MDA underscored its interest in establishing a regulatory sandbox specifically designed for medical devices with emerging technology. An important part of the conversation involved AI-enabled devices, where regulators and industry explored how pilot frameworks could allow safe testing and iteration before wider commercialisation.

2. Medical Device Single Audit Program (MDSAP)

The discussion also emphasised MDSAP and its potential role in streamlining conformity assessment. By leveraging the single audit approach, manufacturers may benefit from reduced duplication of audits, faster regulatory review, and better alignment with international standards.

3. Dialogue and Industry Feedback

The session concluded with an open dialogue, allowing AMMI members and other stakeholders to raise regulatory concerns and propose improvements. This kind of direct engagement helps MDA understand real-world challenges in regulatory compliance and device innovation.

4. Site Visit to Dexcom Factory

In the afternoon, the delegation took part in a site visit to the Dexcom manufacturing plant in Batu Kawan, which produces continuous glucose monitoring devices. This visit not only illustrated the maturity and technical capability of local manufacturing but also reinforced the collaborative nature of MDA’s engagement with high-precision device makers.

Why This Engagement Matters

• Supporting Innovation: By discussing sandbox frameworks, MDA signals that it is open to regulated experimentation, which encourages medical device makers to innovate responsibly.

• Global Alignment: The MDSAP discussion shows MDA’s commitment to harmonising Malaysia’s regulatory system with global conformity assessment practices.

• Strengthened Trust: Open dialogue strengthens trust between regulators and industry, giving companies more clarity on regulatory pathways and reducing uncertainty.

• Local Manufacturing: Visiting a manufacturing facility like Dexcom’s further cements Malaysia’s role as a growing hub for advanced medical device production.

Implications for Industry Stakeholders

• Device Manufacturers (especially those developing AI or high-tech devices) should explore sandbox participation and prepare for MDSAP-related submissions.

• Authorised Representatives need to be aware of MDA’s evolving mindset and align with companies on audit and quality strategies.

• MedTech Investors can view this engagement as a positive signal: Malaysia is serious about balancing innovation and regulatory robustness, making it a promising market.

• Healthcare Providers should monitor regulatory developments, as new devices may enter the market more quickly through sandboxed or audit-streamlined routes.

  
  

Final Thoughts

This Penang engagement between MDA and AMMI is more than a routine meeting; it represents a forward-looking regulatory strategy. By discussing sandboxes, audit reliance, and direct manufacturing collaboration, MDA is building the foundation for a more innovative, transparent, and globally connected MedTech ecosystem in Malaysia.

For companies navigating medical device regulation in Malaysia, staying engaged with MDA and industry associations like AMMI will be increasingly important for planning and strategic alignment.

Source:

Medical Device Authority (MDA), Malaysia “Sesi Libat Urus Bersama AMMI di Pulau Pinang”, 22 September 2025.