On 16 July 2025, the Ministry of Health Malaysia and the Medical Device Authority (MDA) announced a groundbreaking achievement at the HIMSS APAC Health Conference & Exhibition 2025 in Kuala Lumpur, the launch of the Malaysia–China Medical Device Regulatory Reliance Program.
This initiative is the first of its kind globally, setting a new benchmark in international regulatory collaboration for medical devices. It reflects Malaysia's growing leadership role in shaping efficient and forward-looking regulatory ecosystems.
What This Means
Through this arrangement, Malaysia and China will mutually recognize regulatory decisions for in-vitro diagnostic (IVD) medical devices:
- Malaysian IVD devices will be eligible for China's Green Channel.
- Chinese IVD devices will be eligible for Malaysia's Verification Pathway.
This marks a significant shift away from duplicative regulatory processes, allowing both countries to leverage trusted systems for faster, more predictable device approvals.
Why It Matters
The program is expected to deliver wide-reaching benefits:
- Patients gain quicker access to safe, effective, and innovative healthcare technologies.
- Manufacturers benefit from shorter time-to-market and reduced regulatory burden.
- Malaysia strengthens its position as a regional regulatory hub, reinforcing global investor confidence.
What’s Next
The reliance initiative will officially commence on 30 July 2025, kicking off with a pilot phase. Industry stakeholders are encouraged to actively engage with MDA for guidance on participation and to prepare for the program's implementation.
Official Source: Malaysia Leads the World in Medical Device Regulatory Reliance
Published by MDA on 16 July 2025
