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Malaysia: Malaysia-China Medical Device Regulatory Reliance Programme Launches Pilot Phase 1 (30 July 2025 - 30 September 2025)

In a landmark move for international medical device regulation, the Medical Device Authority (MDA) and National Medical Products Administration (NMPA) have jointly launched the Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase 1), running from 30 July to 30 September 2025.


This strategic collaboration, formed under the Global Harmonization Working Party (GHWP) framework, marks the first reciprocal regulatory reliance initiative between Malaysia and China – a first of its kind globally. It represents a new benchmark for regulatory trust, mutual recognition, and market access efficiency, while reinforcing Malaysia’s leadership in international regulatory cooperation.


What Is the Regulatory Reliance Programme?

The programme facilitates mutual recognition of regulatory decisions for in-vitro diagnostic (IVD) medical devices, enabling faster market entry into each country without duplicative evaluations. Approved IVDs from China can access Malaysia’s market via the Verification Pathway, and Malaysian IVDs can enter China through the Green Channel, the fast-track regulatory route.


The pilot programme’s core objectives are to:

  • Accelerate time-to-market for eligible IVD devices

  • Reduce redundant regulatory assessments

  • Strengthen regulatory alignment between Malaysia and China

  • Encourage innovation and improved patient access to medical technology


Who Is Eligible?

The programme sets specific eligibility requirements for manufacturers in both countries:

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Benefits for Industry Stakeholders

This initiative significantly reduces barriers for eligible manufacturers by:

  • Streamlining conformity assessments

  • Enhancing international visibility and recognition

  • Shortening approval timelines without compromising safety or quality

  • Encouraging collaboration in innovation for critical and rare diseases


It also supports Malaysia’s strategic ambition to become a global hub for medical device development, particularly in IVD technology and diagnostics.


Summary Process Flow for Chinese Manufacturers

For Chinese companies aiming to access Malaysia’s market, here’s a simplified application workflow under the Verification Pathway:


  1. Appoint a Malaysian Authorised Representative (AR) and must hold an establishment license issued by MDA

  2. Submit premarket documentation to MDA, including:

    1. ISO 13485 / MDSAP / QSR or equivalent QMS certification

    2. Device info, risk analysis, CSDT documents, and registration certificate from NMPA

  3. Screening by MDA: If eligible, MDA appoints a Conformity Assessment Body (CAB)

  4. CAB conducts verification and issues a certificate and report

  5. AR submits the final registration application via the MeDC@St system

  6. MDA evaluates and issues device registration, valid for 5 years


Final Thoughts 

This pilot programme symbolises more than just regulatory efficiency – it reflects trust, innovation, and the future of cross-border healthcare collaboration. As the medical device industry becomes increasingly globalised, regulatory reliance mechanisms like this are crucial to keeping pace with innovation, ensuring public health safety, and addressing urgent healthcare needs.


MDA encourages all eligible stakeholders to take part in this pilot phase and seek further guidance where needed.


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