On July 16, 2025, the Ministry of Health Malaysia announced the launch of the Medical Device Regulatory Reliance Programme with China. This landmark initiative, revealed during the HIMSS Asia-Pacific Health Conference & Exhibition 2025 in Kuala Lumpur, marks a strategic breakthrough in accelerating patient access to safe and innovative medical technologies.
The programme builds on the Memorandum of Understanding signed between Malaysia’s Medical Device Authority (MDA) and China’s National Medical Products Administration (NMPA) in November 2023, creating a new pathway for mutual recognition of regulatory approvals. It will officially commence on July 30, 2025.
Read the official announcement here: Malaysia Leads the World in Medical Device Regulatory Reliance
Scope and Pathways
The reliance mechanism enables both countries to recognise each other’s pre-market approvals for medical devices, significantly reducing approval timelines.
Direction | Eligible Products | Pathway | Estimated Approval Time | Requirements |
Malaysia → China | IVDs manufactured in Malaysia | Green Channel (NMPA) | ~60 working days | • Facility must be manufacturer-owned and operated in Malaysia • Product registered with MDA |
China → Malaysia | Devices manufactured in China | Verification Pathway (MDA) | ~30 working days | • Facility must be manufacturer-owned and operated in China • Product registered with NMPA |
Key Benefits for Stakeholders
- Reduced regulatory duplication: Fewer repetitive assessments across jurisdictions.
- Improved patient access: Faster availability of safe, quality medical technologies.
- Strengthened regional role: Positions Malaysia as a regulatory hub while boosting investor confidence in its healthcare ecosystem.
Next Steps for Industry
The Ministry of Health and MDA welcome industry participation in this historic programme. Stakeholders are strongly encouraged to engage directly with MDA ahead of the official launch on July 30, 2025, to ensure timely alignment with the new requirements.
This initiative helps minimize regulatory redundancies, accelerates market entry, and enhances patient access to high-quality healthcare technologies.
Register Your Medical Device in Malaysia with Andaman Medical
Andaman Medical is a leading regulatory affairs and market access consultancy in Southeast Asia, including medical device and IVD registration in Malaysia. We support manufacturers entering the Malaysian market with services that include authorized representation, importation, and master distribution to ensure smooth and compliant market entry.
Our in-country experts work directly with the Medical Device Authority (MDA) to provide efficient, end-to-end regulatory support. With full-time local teams and a focus on personalized service, we help manufacturers succeed in Malaysia’s evolving regulatory landscape.
Contact us at sales@andamanmed.com or click below to connect with our Malaysia team.
