The Medical Device Authority (MDA) of Malaysia has announced the launch of the Malaysia–China Joint Evaluation Pilot Programme (Phase 2), which will be conducted from 1 July to 30 September 2026. This programme is a collaboration between the MDA and China's National Medical Products Administration (NMPA) under the Global Harmonization Working Party (GHWP) Common Evaluation Reliance Practice (CERP) framework. This collaboration allows eligible medical device registration applications to be assessed simultaneously by both the MDA and NMPA. The aim of this pilot phase 2 program is to enhance regulatory efficacy and market access, and minimizing duplication of assessment.
Manufacturers intending to participate should ensure that their applications meet the programme's eligibility requirements as shown in the table below.
Programmed Eligibility Requirements
| Requirement | Malaysian-Made Devices | China-Made Devices |
| Regulatory Pathway | Full Conformity Assessment | Special Channel Pilot Programme |
| Manufacturer Requirements | Must be based in Malaysia (own & operate the manufacturing facility) | Must be based in China (own & 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 |
The MDA encourages eligible local manufacturers to participate in this pilot initiative. However, participation is limited to local manufacturers and does not apply to third-party brand owners, including rebranders, relabellers, or contract assemblers.
Manufacturers interested in submitting an application under this programme, must first submit complete premarket documentation or the submission of Class B, C, and D medical devices. The MDA will screen these documents to determine if the application eligibility for Pilot Phase 2. The required premarket documentation includes the following:
- Quality Management System (QMS): ISO 13485, MDSAP, QSR (FDA 31 CFR Part 820), or Japan MHLW Ordinance 169
- Medical device information: Device name, intended use, classification, rule, and grouping
- CSDT documentation
- Post-Market Surveillance (PMS)
- Declaration of Conformity (DoC)
If the application meets the eligibility requirements, MDA will appoint a Conformity Assessment Body (CAB) with the relevant technical code to conduct the conformity assessment for registration in Malaysia, while the application proceeds to the NMPA for registration in China. A detailed step-by-step guide for manufacturers intending to submit applications under the Malaysia–China Joint Evaluation Pilot Programme (Pilot Phase 2) is illustrated in Figure 1.
The Malaysia–China Joint Evaluation Pilot Programme offers eligible manufacturers an opportunity to streamline medical device registration in both markets. With local regulatory teams in Beijing and Selangor, Qualtech supports organizations with eligibility assessment, documentation preparation, and medical device registration in Malaysia and China. Contact us today to discuss your regulatory strategy.
Clarification through Visuals
Process Flow & Explanatory Notes: Submission of Class B, C, and D Devices
Reference
MALAYSIA - CHINA JOINT EVALUATION PILOT PROGRAMME (PILOT PHASE 2: 1ST JULY TO 30 SEPTEMBER 2026)