How the 2026 Malaysia-China Reliance Program Accelerates IVD Registration

1. Programme Overview and Launch

The Malaysia-China Medical Device Regulatory Reliance Programme Pilot Phase I was officially launched on 30 July 2025. This bilateral initiative enables the Medical Device Authority (MDA) of Malaysia to rely on the prior evaluation and approval decisions made by China's National Medical Products Administration (NMPA) for certain in vitro diagnostic (IVD) products. Source: 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

The programme aims to facilitate faster market access for qualified IVDs in Malaysia by leveraging NMPA's rigorous review process, while MDA retains final decision-making authority and ensures compliance with Malaysian-specific requirements.

2. Scope and Eligible IVD Products

The pilot phase covers Class B, C, and D IVDs that have already obtained NMPA marketing approval. Key eligibility criteria include:

• The IVD must be identical in intended use, design, specifications, manufacturing process, and labelling as approved by NMPA
• The product must not have undergone significant post-approval changes
• No unresolved safety or performance concerns from NMPA or other regulators Source: 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

Excluded products include those requiring special local testing or those with unresolved issues in Malaysia.

3. How Reliance Shortens the Registration Timeline

Under the standard MDA registration pathway, IVD review can take 6–12 months or longer depending on class and completeness of submission. The reliance programme significantly accelerates this process:

• Abbreviated Review: MDA relies on NMPA's scientific evaluation, focusing primarily on local requirements (e.g., labelling in Bahasa Malaysia, importer/sponsor obligations, post-market surveillance plans)
• Target Timeline: Approximately 30 working days for review and decision once a complete reliance application is submitted
• No Duplication of Technical Assessment: Eliminates redundant review of core technical dossiers already assessed by NMPA Source: 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

This reduction enables manufacturers to reach the Malaysian market much faster than through the conventional route.

4. Application Process and Required Documents

Applicants must submit a reliance application through the MDA online portal, including:

• Proof of NMPA approval (certificate and decision letter)
• Full technical dossier as submitted to NMPA
• Declaration of conformity to Malaysian requirements
• Local labelling and instructions for use
• Post-market surveillance plan adapted for Malaysia Source: 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

MDA conducts a targeted review focusing on local compliance rather than re-evaluating technical data.

5. MDA Oversight and Local Requirements

While relying on NMPA decisions, MDA maintains full authority and requires:

• Compliance with Malaysian labelling and language requirements
• Appointment of an Authorized Representative in Malaysia
• Establishment of local post-market surveillance and vigilance systems
• Payment of applicable fees Source: 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

Any deviations or Malaysian-specific conditions may extend the timeline beyond the 30-day target.

6. Benefits and Expected Impact

The programme offers several advantages:

• Reduced time-to-market for high-quality Chinese IVDs
• Lower regulatory burden through avoidance of duplicate assessments
• Increased availability of diagnostic tools in Malaysia
• Strengthened bilateral regulatory cooperation Source: 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

The pilot phase will evaluate feasibility and inform potential expansion or permanent implementation.

7. Programme Status and Next Steps

As of the document date (July 2025), the programme is in its pilot phase with ongoing applications accepted. MDA continues to monitor outcomes and gather feedback to refine the process. Future phases may expand scope to other device types or additional regulators. Source: 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

This reliance mechanism represents a significant step in harmonizing regulatory pathways between Malaysia and China, benefiting patients through faster access to safe and effective IVDs.