31/07/2025
Malaysia Takes Global Lead in Medical Device Regulatory Reliance 🌍🔬
Exciting news from Malaysia! 🇲🇾
The Ministry of Health Malaysia and the Medical Device Authority (MDA) have launched a first-of-its-kind international Medical Device Regulatory Reliance Programme with China.
This initiative, announced during HIMSS APAC 2025, allows both countries to mutually recognize regulatory decisions for faster medical device approvals. 🇲🇾🤝🇨🇳
✅ Malaysian IVDs may access China’s Green Channel
✅ Chinese IVDs can use Malaysia’s Verification Pathway
⏱ Approval timelines reduced to 60 and 30 days!
This move reduces duplication, boosts market access, and positions Malaysia as a regional regulatory hub — attracting global healthcare innovation and investment.
📅 Official rollout: 30 July 2025
🗣 Industry stakeholders are invited to engage with MDA for collaboration.