Regulatory cooperation initiatives are intensifying in East and Southeast Asia, aiming to streamline medical device evaluation processes and shorten time-to-market. Two pilot programs, Malaysia-Singapore and Malaysia-China, represent the most recent and tangible examples of this trend.

Malaysia and Singapore: Memorandum of Understanding and Regulatory Reliance Pilot

On August 22, 2025, the Medical Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore signed a Memorandum of Understanding (MoU) and launched the “Medical Device Regulatory Reliance Programme” pilot project, which runs for six months from September 1, 2025, to February 28, 2026.

This regulatory cooperation under the Malaysia-Singapore Medical Device Regulatory Reliance Programme was created to facilitate a simplified medical device registration process between the two countries for Class B, C, and D devices.

Manufacturers who choose to participate in the project can expect reduced review times for medical device registration in both countries:

• In Malaysia: Devices already approved by the HSA can be submitted via a verification route (abridged review pathway) through an MDA-recognized Conformity Assessment Body (CAB). Review via this pathway is expected to take approximately 30 working days instead of the 60 days for the full conformity assessment route.
• In Singapore: Devices registered with the MDA in Malaysia can be evaluated with an abridged review process that reduces evaluation times by up to 30% for all Class B and D Medical Devices, compared to current standard timelines.

At the end of the pilot project (February 28, 2026), the authorities will evaluate the results and may decide whether to extend or make the reliance scheme permanent.

Malaysia and China: Pilot Project on IVDs

The MDA of Malaysia and China’s National Medical Products Administration (NMPA) have activated a pilot project for IVD devices, based on a Memorandum of Understanding (MoU) signed in November 2023. This initiative, which represents the world’s first reciprocal regulatory agreement under the Global Harmonization Working Party (GHWP), aims to accelerate market access for selected IVDs.

Pilot Phase I runs from July 30, 2025, to September 30, 2025, with the goal of accelerating market access for selected IVDs.

Thanks to these agreements, bilateral cooperation translates into concrete advantages in terms of timelines. For IVDs manufactured in Malaysia, access to the Chinese market can be significantly accelerated through the Green Channel program. Similarly, Chinese-made IVDs benefit from a more streamlined review in Malaysia through the Verification Pathway.

The eligibility criteria to participate in this pilot project are strict and operational:

• Malaysian IVDs in China: Class B, C, or D IVDs approved by the MDA can access the so-called “China Green Channel.” The program offers an accelerated pathway, with a significant reduction in approval times compared to standard practices.
• Chinese IVDs in Malaysia: Class II IVDs approved by the Provincial MPA or Class III IVDs approved by the NMPA can use the MDA’s Verification Pathway.

Among the eligibility requirements for joining the project:

• Third-party brand owners (e.g., rebranders, relabelers, or assemblers) are excluded.
• There is a limit of 6 applications per contact (for submission to the MDA).
• Applications for rare diseases and innovative Medical Devices will be given priority.

A Key Step for Companies in the Sector

The regulatory cooperation initiatives in Malaysia-Singapore and Malaysia-China signal that this drive for harmonization is creating a new regulatory and economic force in the region. This scenario not only offers fabricantes faster pathways but also prompts new market access strategies.

Manufacturers who are able to leverage the evolution of these agreements and position themselves strategically will be the first to benefit from the consolidation of these new regulatory alliances.

Update of October 15, 2025

• Expansion of Recognized Countries: With MDA Circular No. 2/2025 (October 15, 2025), the MDA has formally added Singapore and Thailand to the list of Recognized Regulatory Authorities (which already includes the USA, EU, Canada, Australia, Japan, and UK).
• Procedural Clarification: The application of this abbreviated pathway is now defined in detail by the new guides MDA/GD/0068 (for Conformity Assessment Bodies) and MDA/GD/0070 (for Manufacturers/Establishments).

Sources

• https://www.hsa.gov.sg/medical-devices/international-collaboration-medical-devices/regulatory-reliance
• https://mda.gov.my/index.php/announcement/1623-press-release-singapore-reliance
• https://www.mda.gov.my/index.php/announcement/1611-press-release-malaysia-leads-the-world-in-medical-device-regulatory-reliance
• https://portal.mda.gov.my/index.php/documents/ukk/3707-implementation-of-the-malaysia-china-medical-device-regulatory-reliance-programme-pilot-phase-i-30072025-2/file