Malaysia-Singapore Regulatory Reliance Pilot Speeds Medical Device Registration

Malaysia and Singapore regulatory reliance pilot, starting 1 September 2025, introduces a six-month program to simplify medical device registration, helping international manufacturers achieve faster approvals, minimize duplication, and reach ASEAN markets sooner.

Background and Purpose

On 22 August 2025, the Medical Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore signed a Memorandum of Understanding (MOU) to deepen regulatory cooperation and officially launched a 6-month pilot of the Medical Device Regulatory Reliance Programme as part of the MOU.

Purpose:

Faster approvals: Reliance on each other’s regulatory assessments and approvals.
Reduced duplications: Cutting costs and time-to-market.
Earlier patient access: Safe, innovative, and high-quality medical technologies.

What the Industry Can Expect

Through this pilot programme, both regulators will test streamlined pathways, refine operating procedures for the reliance pathway, validate shortened processing timelines, and gather stakeholder feedback.
For Malaysia: Devices registered with HSA may undergo a verification route (abridged review pathway) through MDA’s Conformity Assessment Body (CAB). The review is expected to take 30 working days, compared to 60 working days under the full route, and registration will then be completed within 30 working days.
For Singapore: Devices registered with MDA will benefit from an abridged review pathway, achieving up to 30% shorter review times across all Class B to D medical devices.

Next Steps

This MOU is a testament to the commitment of both countries to work together towards advancing regional economic integration. At the conclusion of the pilot, MDA and HSA will jointly evaluate the outcomes and consider full scale implementation of the regulatory reliance programme. Interested stakeholders are encouraged to contact the respective regulatory authorities for further details.

What This Means for Manufacturers

The pilot creates concrete opportunities for manufacturers to accelerate their device registration strategies across ASEAN. Key benefits include:

Origin of Device RegistrationFast-Track PathwayExpected TimelineSingapore (HSA)Fast-track entry into Malaysia via abridged CAB review~30 working daysLeverage approvals for faster pathways into Thailand, Philippines, Hong KongDependent on respective regulatorsMalaysia (MDA)Fast-track entry into Singapore via abridged review pathway~30% shorter review timelines

This pilot reduces duplications, lowers costs, and speeds up patient access to safe and innovative medical devices. Running from 1 September 2025 to 28 February 2026, it represents a golden opportunity for manufacturers aiming to expand across ASEAN.

Further Information

To read the original announcement about the Memorandum of Understanding and regulatory reliance pilot signed by the Health Sciences Authority (HSA) and the Medical Device Authority (MDA) on 22 August 2025, please click here.

If you are a medical device manufacturer with questions about how long it takes or how much it costs to register your product in Malaysia or Singapore, please contact Cisema.