The Medical Device Authority (MDA) announced the commencement of the Malaysia–China Joint Evaluation Pilot Programme, Pilot Phase 2, from 1 July to 30 September 2026 under the Global Harmonization Working Party (GHWP) Common Evaluation Reliance Practice (CERP) framework.
The pilot introduces a Joint Evaluation approach between MDA Malaysia and NMDA / NMPA China, where both regulatory authorities will conduct a collaborative and simultaneous assessment of medical device applications.
This aims to improve regulatory efficiency, reduce duplicated evaluations, and accelerate market access for safe and high-quality medical devices in both countries.
The programme is open to eligible Malaysia-made and China-made medical devices that meet the specified requirements. However, it is not open to third-party brand owners, including rebranders, relabellers, or contract assemblers.
Read the full update here:
https://portal.mda.gov.my/index.php/documents/ukk/4222-malaysia-china-joint-evaluation-pilot-programme-phase-2/file
Purpose of the Pilot Programme
To introduce a Joint Evaluation approach between MDA Malaysia and NMDA / NMPA China under the GHWP Common Evaluation Reliance Practice (CERP) framework.
To support collaborative and simultaneous assessment of eligible medical device applications by both regulatory authorities.
To improve regulatory efficiency, reduce duplicated evaluations, and support faster market access for safe and high-quality medical devices in Malaysia and China.
Scope of Application
The programme is open to eligible Malaysia-made and China-made medical devices that meet the specified requirements.
It is not open to third-party brand owners, including rebranders, relabellers, or contract assemblers.
Key Highlights
Eligible Criteria for the Malaysia–China Joint Evaluation Pilot Programme, Pilot Phase 2
| Requirement | Malaysian-Made Devices | China-Made Devices |
| Regulatory Pathway | Full Conformity Assessment | Special Channel Pilot Programme |
| Manufacturer Requirements | Must be based in Malaysia and own and operate the manufacturing facility | Must be based in China and own and operate the manufacturing facility |
| Device Classes | Class B, C, or D, GMD or IVD | Class II or Class III, GMD or IVD |
| Prior Registration Status | The device must not have obtained registration certificates in Malaysia or China | The device must not have obtained registration certificates in China or Malaysia |
| Submission Authority | MDA, Malaysia | NMPA, China |
| Contact Email | cab.registration@mda.gov.my | info@ChinaMedDevice.com |
Submission Guidance
For detailed process information, applicants should refer to Appendix 1 for further guidance and explanatory notes on the submission requirements to MDA.
Implications 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.
Effective Date
1 July 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.