Malaysia and Thailand Strengthen Regulatory Cooperation: Full Implementation of Medical Device Reliance Programme

Regional regulatory collaboration in Southeast Asia is entering a new phase, as Medical Device Authority Malaysia and the Thai Food and Drug Administration officially announce the full implementation of their Medical Device Regulatory Reliance Programme in May 2026.

This milestone follows the successful completion of a three-month pilot phase and represents a significant step toward regulatory harmonisation and more efficient market access across the ASEAN region.

From Pilot to Full Implementation

The initiative was first introduced following a confidentiality agreement signed during the 29th GHWP Annual Meeting in December 2025.

After a pilot phase conducted between 1 February and 30 April 2026, both authorities confirmed that the reliance model effectively:

• Reduced duplication in regulatory assessments

• Accelerated approval timelines

• Improved access to medical technologies

With these outcomes, the programme has now transitioned into full implementation, marking a long-term commitment to regulatory cooperation.

What Is the Regulatory Reliance Programme?

The Medical Device Regulatory Reliance Programme allows one regulatory authority to leverage the evaluation and approval decisions of another trusted authority.

Under this framework:

• Malaysia and Thailand can recognise each other’s regulatory decisions

• Manufacturers can avoid repeating full evaluation processes

• Approval pathways become more efficient and streamlined

  
  

This approach aligns with international best practices, including the World Health Organisation principles on Good Reliance Practices.

How the Programme Works

The programme applies to Class B, C, and D medical devices, covering medium- to high-risk products.

Malaysia (MDA) Verification Route

Medical devices approved by the Thai FDA can:

• Utilise a verification pathway

• Bypass full conformity assessment

• Benefit from a faster registration process

Thailand (Thai FDA) Reliance Pathway

Medical devices approved by Malaysia’s MDA can:

• Skip external expert evaluation

• Avoid a full Common Submission Dossier Template (CSDT) review

• Achieve streamlined approval

  
  

  Why This Matters for Medical Device Manufacturers

This development brings significant strategic advantages for companies operating in Southeast Asia.

1. Faster Market Access

Manufacturers can leverage prior approvals to reduce time-to-market in neighbouring countries.

2. Reduced Regulatory Burden

Duplicative evaluations are minimised, lowering administrative complexity.

3. Stronger Regional Strategy

Companies can adopt a multi-market regulatory approach, using one approval to support entry into another.

A Step Toward ASEAN Regulatory Harmonisation

The full implementation of this programme signals a broader regional trend toward regulatory convergence and cooperation.

By aligning processes and recognising each other’s regulatory decisions, Malaysia and Thailand are:

• Strengthening the regional medical device ecosystem

• Supporting innovation and faster access to healthcare technologies

• Enhancing efficiency while maintaining safety and quality standards

This initiative positions both countries at the forefront of ASEAN regulatory modernisation.

Strategic Considerations for Manufacturers

To fully benefit from the reliance programme, companies should:

• Plan regulatory submissions strategically across both markets

• Identify the most efficient primary approval pathway (Malaysia or Thailand)

• Ensure compliance with both authorities’ documentation requirements

• Monitor further developments as reliance models expand within the region

A well-structured regulatory strategy can significantly improve market entry timelines and operational efficiency.

How ARQon Can Support

At ARQon International Group, we support medical device manufacturers in navigating complex and evolving regulatory environments across Asia.

Our services include:

• Regulatory strategy across multi-market frameworks

• Medical device registration and reliance pathway support

• Regulatory intelligence and monitoring

• Market entry and expansion planning

As reliance models continue to reshape regulatory pathways in ASEAN, we help companies leverage these opportunities for faster, smarter, and compliant market access.