The Medical Device Authority (MDA) has officially launched the Malaysia–China Medical Device Regulatory Reliance Program (Pilot Phase 1), running from 30 July to 30 September 2025. This initiative represents the first reciprocal regulatory arrangement of its kind under the Global Harmonization Working Party (GHWP) framework, marking a major step in international regulatory cooperation.
What the Program Involves
Under this pilot program, Malaysia (MDA) and China (NMPA) will mutually recognize regulatory decisions for in-vitro diagnostic (IVD) medical devices, aiming to speed up approvals and reduce duplicative evaluations. This cooperation follows the MoU signed in November 2023 between the two regulators.
The arrangement will allow:
- Chinese-made IVD devices: Eligible for Malaysia's Verification Pathway
- Malaysian-made IVD devices: Eligible for China's Green Channel
Both sides will prioritize devices addressing rare diseases or demonstrating innovation, reflecting the program's focus on public health impact and regulatory efficiency.
For more background on how this bilateral initiative came about, you can read the earlier post on the press release announcement here:
Eligibility Highlights
- Manufacturer location: Must be based in the home country (China or Malaysia).
- Facility ownership: Manufacturer must own and operate its facility locally.
- Exclusions: Third-party brand owners (e.g., rebranders, relabelers, assemblers) are not eligible.
- Device classes:
- For Chinese-made devices: Class II (Provincial MPA approved) or Class III (NMPA approved)
- For Malaysian-made devices: Class B, C, or D (MDA approved)
- Application limits: Maximum of 6 applications per side during the pilot phase.
Why It Matters
This pilot is not just a bilateral arrangement, it signals a new era of regulatory reliance and trust, aligning with global efforts to harmonize medical device regulations. By cutting redundancies in approval processes, the initiative is expected to:
- Enable faster market access for IVD devices in both Malaysia and China
- Encourage regulatory efficiency and innovation
- Provide patients with quicker access to safe, effective, and high-quality diagnostic devices
MDA is encouraging all eligible stakeholders to take part in this program. Manufacturers are advised to carefully review the documentation requirements and consult directly with MDA or NMPA for further guidance.
For application procedures, submission flow, and detailed requirements (including CSDT documentation and verification steps), please refer to the full announcement and guidance document provided by MDA:
Official Source: Announcement Update: Implementation of the Malaysia–China Medical Device Regulatory Reliance Program (Pilot Phase 1: 30 July - 30 September 2025)
Published by MDA on 30 July 2025
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