On July 30, 2025, the Medical Device Authority (MDA) released an official announcement regarding the Implementation of the Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I). The programme is a result of a Memorandum of Understanding (MoU) signed between the MDA (Malaysia) and the National Medical Products Administration (NMPA) (China), aligning with the principles of the Global Harmonization Working Party (GHWP).
To view the official announcement, refer to:
Implementation of the Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I)
Key Highlights
Programme Objective:
To enhance regulatory efficiency and accelerate market access for eligible medical devices in both Malaysia and China.
Pilot Phase Duration:
30 June 2025 – 30 September 2025
Background:
The programme follows a Memorandum of Understanding (MoU) signed between the MDA (Malaysia), NMPA (China), and the National Medical Products Administration (NMPA) (China) on medical devices. It aligns with the Global Harmonization Working Party (GHWP) principles.
Contact for Further Guidance:
Call Registration Unit (CABMU) and MDA contacts provided at the end of the document.
Eligible Criteria for the Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I)
Requirement | Chinese-Made IVD Devices | Malaysian-Made IVD Devices |
Regulatory Pathway | Eligible for Malaysia’s Verification Pathway | Eligible for China’s Green Channel |
Manufacturer Location | Based in China | Based in Malaysia |
Facility Ownership | Manufacturer must own and operate its facility in China | Manufacturer must own and operate its facility in Malaysia |
Exclusions | Third-party brand owners (e.g., rebranders, relabelers, assemblers) | Third-party brand owners (e.g., rebranders, relabelers, assemblers) |
Device Classes | Class II approved by Provincial MPA or Class III approved by NMPA | Class B, C, or D approved by MDA |
Priority | Priority given to applications involving rare diseases and innovative medical devices | Not stated |
Application Limit | 6 applications* | 6 applications |
Contact Email |
For detailed process information, please kindly refer to Appendix 1, titled “Submission of Class B, C and D Chinese-Made IVD Devices to MDA for Malaysia’s Verification Pathway.” This appendix includes a flowchart and detailed steps covering documentation and contact procedures for successful submission
Implementation Date:
30 July 2025 – 30 September 2025
Implication to Clients
Eligible clients are strongly advised to take timely action by preparing the necessary documentation, appointing a licensed Malaysian Authorized Representative (AR), and submitting their applications within the specified timeframe. This pilot initiative represents a significant advancement in regulatory efficiency and international collaboration. Companies that meet the criteria are encouraged to leverage this opportunity to expedite market entry into Malaysia.
For more information or assistance, contact us at sales@andamanmed.com or click the button below.
