Singapore medical device sector is set for a transformative shift with the launch of the first regulatory reliance pilot, a landmark collaboration between Singapore’s Health Science Authority (HSA) and Malaysia’s Medical Devices Authority (MDA) that promises to accelerate access to advanced medical technologies across the region. These efforts will further solidify Singapore's reputation as a hub for cutting-edge medical research and technological progress, says GlobalData.

The six-month pilot of the Medical Device Regulatory Reliance Programme, running from 1 September, 2025 to 28 February, 2026, aims to expedite market access for Class B, C and D medical devices by reducing duplicate regulatory reviews and leveraging each other's approvals. The pilot also reflects a broader trend across Asia to embrace regulatory convergence, fostering stronger alignment with global best practices while reducing compliance costs for manufacturers.

Nidhi Bharti, Medical Devices Analyst, GlobalData, commented, “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.

“For Singapore, this enhances its competitiveness as a preferred entry point into the ASEAN market, while Malaysia stands to strengthen its regulatory credibility and attract higher-quality medical technologies.”

Under this programme, both agencies will leverage reliance pathways by drawing on each other’s regulatory assessments to fast-track device evaluations while upholding the highest standards of patient safety and product quality.

The reliance pathway is expected to help manufacturers in Singapore with up to 30 percent shorter review times across multiple device categories. Such efficiency gains are expected to encourage more cross-border filings, reduce time-to-market and ultimately improve 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 the pilot proves successful, it could become a blueprint for broader ASEAN-wide cooperation, significantly boosting investor confidence and stimulating growth in the region’s rapidly expanding medical devices industry.”