Singapore’s medical device sector is poised for significant advancement with the introduction of the first regulatory reliance pilot, a collaborative effort between Singapore’s Health Science Authority (HSA) and Malaysia’s Medical Devices Authority (MDA). This initiative aims to accelerate access to advanced medical technologies in the region by reducing duplicate regulatory reviews and leveraging mutual approvals.
The six-month Medical Device Regulatory Reliance Programme, running from 1 September 2025 to 28 February 2026, targets Class B, C, and D medical devices. It reflects a broader trend in Asia towards regulatory convergence, aligning with global best practices and reducing compliance costs for manufacturers.
Nidhi Bharti, a Medical Devices Analyst at GlobalData, stated, “Operationalising regulatory reliance marks a decisive move towards greater regulatory sophistication in the region, building shared expertise, accelerating innovation pipelines, and positioning Southeast Asia as an influential driver in global medtech development.”
Under this programme, both agencies will utilise reliance pathways, drawing on each other’s regulatory assessments to fast-track device evaluations whilst maintaining high standards of patient safety and product quality. This approach is expected to reduce review times by up to 30% for manufacturers in Singapore, encouraging more cross-border filings and improving patient access to life-saving innovations.
Bharti concluded, “By embracing regulatory reliance and deepening cross-border collaboration, Singapore is not only accelerating access to vital medical devices but also reinforcing its standing as a hub for regulatory excellence and global medtech innovation.” If successful, the pilot could serve as a model for broader ASEAN cooperation, boosting investor confidence and stimulating growth in the region’s medical devices industry.
