Malaysia-China Joint Evaluation Pilot Programme 2026

The Malaysia-China Joint Evaluation Pilot Programme 2026 marks a significant milestone in regulatory collaboration between Malaysia's Medical Device Authority (MDA) and China's National Medical Products Administration (NMPA). Running from 1 July to 30 September 2026, the second pilot phase introduces a joint evaluation approach that enables simultaneous regulatory assessment by both authorities to streamline medical device registration while maintaining safety and performance standards.

What is the Malaysia-China Joint Evaluation Pilot Programme?

Following the Malaysia-China Medical Device Regulatory Reliance Programme (Pilot Phase I) in 2025, MDA has launched Pilot Phase 2 under the Global Harmonization Working Party (GHWP) Common Evaluation Reliance Practice (CERP) framework.

Unlike the previous reliance model, the new programme allows MDA and NMPA to conduct collaborative, simultaneous evaluations of eligible medical devices. The objective is to reduce duplicate regulatory reviews, improve regulatory efficiency, and accelerate patient access to safe, effective, and high-quality medical devices in Malaysia and China while maintaining rigorous regulatory standards.

Pilot programme timeline

The second phase of the Malaysia-China Joint Evaluation Pilot Programme will accept applications during the following period:

Manufacturers intending to participate should prepare all required documentation before the submission window closes.

Eligibility criteria

The programme is available to eligible manufacturers in Malaysia and China.

MDA also notes that the programme does not apply to third-party brand owners, relabelers, rebranders, or contract assemblers.

Submission process for Malaysian manufacturers

Manufacturers participating through Malaysia must complete several regulatory steps before obtaining registration.

The process includes:

• Hold a valid MDA Establishment Licence.
• Submit premarket documentation to MDA for eligibility screening.
• Undergo screening for participation in Pilot Phase 2.
• Complete a full conformity assessment with an assigned Conformity Assessment Body (CAB).
• Submit the medical device registration application through the MeDC@St system.
• Following successful evaluation, receive an MDA registration certificate.
• The device is listed in the Medical Device Register (MDAR) for five years.
• Submit the corresponding application to NMPA for the joint evaluation process.

Required premarket documentation

To participate in the pilot programme, manufacturers must submit complete documentation during the initial screening stage.

The required submission includes:

• Quality Management System certification (ISO 13485, MDSAP, FDA QSR, or Japan MHLW Ordinance 169)
• Medical device information, including intended use and classification
• Common Submission Dossier Template (CSDT) documentation
• Executive Summary
• Essential Principles of Safety and Performance (EPSP)
• Design verification and validation summary
• Pre-clinical and software validation data
• Clinical performance information
• Labelling and Instructions for Use (IFU)
• Risk analysis documentation
• Manufacturing process information
• Post-Market Surveillance (PMS) documentation
• Declaration of Conformity (DoC)

Incomplete applications will not proceed to the conformity assessment stage.

Conformity assessment requirements

Eligible devices must undergo a full conformity assessment conducted by an MDA-designated Conformity Assessment Body (CAB) with the appropriate technical expertise.

The conformity assessment is performed in accordance with MDA/GD/0031 - Conformity Assessment for Medical Devices. Upon successful assessment, the CAB issues the conformity assessment certificate and report, allowing the registration process to continue.

Why this pilot programme matters

The Malaysia-China Joint Evaluation Pilot Programme demonstrates the growing adoption of regulatory reliance and collaborative assessment models in the Asia-Pacific region.

For eligible manufacturers, the programme may offer several potential benefits, including:

• Reduced duplication of regulatory evaluations.
• Improved regulatory efficiency between Malaysia and China.
• Faster access to two important medical device markets.
• Greater alignment with international regulatory harmonization initiatives under the GHWP framework.

Manufacturers developing innovative medical devices or IVDs may benefit from more coordinated market access strategies through this pilot initiative.

Planning for participation

Manufacturers interested in participating should begin preparing before the application window closes.

Key preparation activities include:

• Confirming eligibility under the pilot programme.
• Verifying that the manufacturing facility satisfies programme requirements.
• Reviewing technical documentation against CSDT requirements.
• Ensuring Quality Management System certificates remain valid.
• Coordinating submission timelines with regulatory teams in Malaysia and China.

Early preparation can help avoid delays during eligibility screening and conformity assessment.

Conclusion

The Malaysia-China Joint Evaluation Pilot Programme 2026 represents an important step towards greater regulatory collaboration between MDA and NMPA. By enabling simultaneous assessments under the GHWP CERP framework, the programme aims to improve regulatory efficiency while maintaining high standards of safety and performance. Eligible manufacturers should review the programme requirements carefully and prepare their technical documentation in advance to maximize the opportunity for streamlined market access in both countries.

Internal links

• MDA Malaysia Medical Device Registration
• Malaysia-China Medical Device Reliance Programme Launches Pilot for IVD Fast-Track Access
• Malaysia-China Medical Device Reliance 2025 Launch
• NMPA China Medical Device Registration & Approval

External links

• Official MDA announcement for Malaysia-China Joint Evaluation Pilot Programme Phase 2