Malaysia–China Medical Device Reliance Programme Launches Pilot for IVD Fast-Track Access

Following our previous update on the Malaysia–China Medical Device Reliance 2025 published on July 23; we are pleased to inform stakeholders that the Medical Device Authority (MDA) of Malaysia has officially launched the Pilot Phase I of the Malaysia–China Medical Device Regulatory Reliance Programme.

Running from 30 July to 30 September 2025, this pilot enables expedited cross-border market access for in-vitro diagnostic (IVD) medical devices via mutual recognition with China’s National Medical Products Administration (NMPA). This groundbreaking initiative reinforces regulatory trust and cooperation under the Global Harmonization Working Party (GHWP) framework and marks a significant step toward regional harmonization and streamlined approvals.

Key Details of the 2025 Pilot Phase

The Pilot Phase I runs from 30 July to 30 September 2025 and is based on the MoU signed in November 2023 between MDA and NMPA. This regulatory reliance arrangement is designed to:

• Enhance regulatory efficiency

• Reduce duplicative assessments

• Improve access to high-quality IVD devices

Eligibility Criteria: Who Can Apply?

Submission Contacts:

• To Malaysia: cab.registration@mda.gov.my

• To China: info@ChinaMedDevice.com

How to Submit: Process for Chinese IVD Devices into Malaysia

Step-by-Step Process:

1. Appoint a Malaysian Authorized Representative (AR)

2. Submit premarket documents to MDA

3. MDA reviews application for eligibility

4. CAB conducts verification upon approval

5. AR submits full registration via MeDC@St system

6. Upon MDA’s approval, device is listed in MDAR for 5 years

Required Documents Include:

• ISO 13485 / MDSAP / QSR compliance

• Class II or Class III registration from China

• Full CSDT dossier

• Clinical & lab data

• Risk analysis and PMS documentation

• Labeling, IFU, brochures

• Declaration of Conformity

Full submission details: MDA Announcement update

Impact on Market Access

This bilateral pilot allows faster parallel access to two of Asia’s largest MedTech markets. Manufacturers save time, reduce regulatory burden, and boost competitiveness. This also signals Malaysia’s rising leadership in international regulatory convergence within the GHWP and ASEAN Medical Device Directive (AMDD) frameworks.

Why This Update Matters

This is the implementation phase—not a proposal. Eligible manufacturers can now act to benefit from a streamlined approval process that could shape the future of global medical device regulation.

Next Steps for Manufacturers

• Chinese IVD firms: Begin preparing documentation and appoint your AR in Malaysia.

• Malaysian IVD firms: Contact your China liaison and confirm eligibility under the Green Channel.

Resources

• Pure Global - Malaysia Medical Device Classification

• Pure Global - MDA Malaysia Medical Device Registration

• Pure Global - NMPA China Medical Device Registration & Approval

Malaysia’s MDA and China’s NMPA are piloting a 2025 reliance programme for IVD devices. Qualified Class II/III devices from China and Class B–D devices from Malaysia may apply for fast-track approval. Pure Global outlines how to apply and benefit from this bilateral pathway.

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