Malaysia-Thailand 2026 Medical Device Regulatory Reliance Pilot

The Malaysia-Thailand Medical Device Regulatory Reliance Pilot 2026 is a 3-month program running from 1 February to 30 April 2026, designed to streamline registration of class B/C/D (2/3/4) medical devices. By leveraging mutual regulatory assessments, the pilot reduces duplicated reviews, shortens time-to-market, lowers costs, and gives patients faster access to safe and high-quality devices. Manufacturers with prior approval in either country can take advantage of this fast-track regulatory pathway.

Strategic Importance of the Pilot

• Marks a new chapter in regulatory convergence and industry cooperation between Malaysia and Thailand.

• Serves as a sandbox for ASEAN member states in regulatory reliance.

• Reduces duplication of regulatory assessments and accelerates device availability.

Benefits of the Malaysia-Thailand Regulatory Reliance Program

• Faster approvals: Both countries rely on each other’s regulatory assessments.

• Cost efficiency: Minimizes duplicated reviews and associated fees.

• Improved patient access: Innovative and high-quality devices reach the market sooner.

Malaysia Registration Pathway

• Eligible Devices: Class 2/3/4 medical devices registered with Thai FDA.

• Review Route: Verification route (abridged pathway) via Conformity Assessment Body (CAB).

• Timeline: Review in 30 working days (compared with 60 days under full route) and device registration completed within 30 working days.

• Benefits: Reduces regulatory burden and accelerates market entry.

Learn more about MDA Malaysia Medical Device Registration

Thailand Registration Pathway

• Eligible Devices: Class B/C/D devices registered with MDA Malaysia.

• Review Route: Full submission pathway without external expert review.

• Timeline: Reduced from 150 to 120 calendar days; expert review fees waived.

• Benefits: Streamlines approvals and reduces costs for manufacturers.

Learn more about Thai FDA Medical Device Registration

Who Benefits Most

• Devices without reference country approval (USA, EU, Canada, Australia, Japan) gain significant advantages under this pilot.

• Devices already approved in reference countries do not gain additional benefits under this Reliance pathway.

• Products with reference country approval older than 1 year already qualify for Thailand’s expedited pathway.

Future Reliance Programs

• At the Malaysia Pharma and Healthcare Expo 2025, MDA indicated plans to explore reliance with India, Brazil, Indonesia, Pakistan, Egypt, UAE, and Turkey.

• Thailand is the first confirmed pilot, but more Reliance programs may be announced later in 2026.

Duration and Limitations

• A prior Malaysia-China Reliance program (30 July–30 September 2025) has no confirmed extension.

• Similarly, there is no guarantee that the Malaysia-Thailand Reliance Pilot will continue after 30 April 2026.

• Manufacturers with non-reference country approved devices should take advantage while the pilot is active.

Key Takeaways for Manufacturers

• Streamlined approval pathways can significantly shorten time-to-market.

• Cost and regulatory burden are reduced.

• Early adoption is crucial due to the limited pilot duration.

• Supports regional harmonization and sets a precedent for future ASEAN regulatory reliance initiatives.

External Links:

• Medical Device Authority (MDA) Malaysia

• Thai FDA Official Website

• Official LinkedIn Announcement

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