Malaysia–Thailand Regulatory Reliance Pilot Opens Faster Pathway for Medical Device Approvals

On December 4, 2025, the Medical Device Authority (MDA) of Malaysia and the Thai Food and Drug Administration (Thai FDA) signed a bilateral confidentiality agreement enabling the exchange of non-public regulatory information. The agreement accompanies the launch of a Medical Device Regulatory Reliance Pilot Program between the two authorities.

Running from February 1, 2026, to April 30, 2026, the pilot will test whether each regulator can rely on assessment outcomes from the other when reviewing medical device applications.

For overseas manufacturers seeking approval in both markets, the initiative could reduce duplicate technical reviews and support faster regulatory timelines for eligible devices.

Malaysia and Thailand Establish Confidentiality Framework for Regulatory Cooperation

The Confidentiality Agreement establishes the legal foundation that allows Malaysia’s MDA and the Thai FDA to securely exchange regulatory information during product evaluations.

Under the agreement, both authorities may share:

• Non-public regulatory information
• Technical assessment reports
• Evaluation outcomes and regulatory conclusions

By formalizing data-sharing mechanisms, the agreement ensures that reliance activities can occur within a controlled and transparent regulatory environment. This structure also allows each authority to review counterpart assessment findings while maintaining regulatory independence.

Regulatory Reliance Pilot Program Timeline and Scope

The Medical Device Regulatory Reliance Pilot Program will operate for three months, from February 1 to April 30, 2026. During this period, participating applications may be evaluated using a reliance-based review approach.

Under the pilot framework, one regulatory authority may reference assessment outcomes already conducted by the counterpart authority when reviewing eligible medical device submissions. This approach is intended to reduce duplication in technical evaluations and potentially shorten regulatory review timelines.

The program applies to medical device registrations in the following risk classifications:

• Class B medical devices
• Class C medical devices
• Class D medical devices

These categories represent moderate- to high-risk devices under the classification systems used in both Malaysia and Thailand. Applications within these classifications may be considered for reliance-based evaluation during the pilot period.

The initiative is designed to assess whether structured regulatory reliance can improve review efficiency while maintaining safety, quality, and performance standards. Importantly, both regulators will continue to retain full decision-making authority for approvals issued within their respective jurisdictions.

What the Pilot Means for Medical Device Manufacturers

For medical device manufacturers and authorized representatives seeking approvals in both Malaysia and Thailand, the pilot program may provide a more coordinated regulatory pathway.

Potential benefits include:

• More efficient dual-market registration strategies
• Reduced duplication in technical dossier reviews
• Greater predictability in regulatory timelines

Medical Device Registration Certificate Holders participating in the pilot can expect reduced review times for medical device registration in both countries:

Malaysia: Verification Route for Devices Approved by Thai FDA

Medical devices already registered with the Thai FDA may qualify for a verification route (abridged review pathway) through the Medical Device Authority’s Conformity Assessment Body (CAB).

Under this pathway:

• Technical review is expected to take 30 working days, compared with 60 working days under the full conformity assessment route.
• Following CAB verification, the device may be registered within an additional 30 working days.

Thailand: Accelerated Review for Devices Approved by MDA

Medical devices registered with the Malaysian Medical Device Authority (MDA) may proceed through the full submission pathway without external expert review in Thailand.

This change provides two key efficiencies:

• The regulatory review timeline may be reduced from 150 calendar days to 120 calendar days.
• The external expert review fee is waived.

Preparing Submissions for the Malaysia–Thailand Reliance Pathway

Manufacturers planning medical device submissions in Malaysia or Thailand during the pilot period should review eligibility requirements and consider how regulatory documentation prepared for one authority may support reliance-based evaluation by the other.

Supporting Medical Device Compliance Across Asia

Regulatory cooperation initiatives such as the Malaysia–Thailand reliance pilot reflect a broader shift toward more coordinated and efficient medical device oversight across Asia. For international manufacturers, these developments can create opportunities to streamline regulatory strategies across multiple markets.

However, taking advantage of these pathways still requires careful regulatory planning. Technical documentation, regulatory data, and submission timelines must be aligned across jurisdictions to ensure efficient approvals.

Cisema supports international manufacturers through this process, providing end-to-end regulatory compliance services for medical device registration and lifecycle management across Southeast Asia — including Malaysia and Thailand — as well as China, Hong Kong, and Taiwan.

For companies planning medical device market entry or regulatory submissions in the region, contact Cisema to help streamline approvals and maintain compliance across Asia’s evolving regulatory landscape.

Further Information

Learn more about Cisema’s medical device registration services across Southeast Asia, or explore our country-specific services:

• Malaysia medical device registration services
• Thailand medical device registration services

References

Medical Device Authority (MDA), Malaysia. “Malaysia and Thailand Sign Confidentiality Agreement and Launch Medical Device Regulatory Reliance Pilot to Fast-Track Medical Device Market Access.”