Singapore: Launch of Medical Device Regulatory Reliance Pilot

On 1 September 2025, Singapore’s Health Sciences Authority (HSA) and Malaysia’s Medical Device Authority (MDA) launched a six-month pilot programme to streamline the approval process for medical devices. Known as the Medical Device Regulatory Reliance Programme, it applies to devices in Classes B, C, and D.

Through this initiative, regulators in both countries will rely on each other’s prior assessments when reviewing new device applications. This reduces the need for repetitive evaluations, helping to accelerate market entry and reduce costs while ensuring that safety and quality standards remain in place. For patients and healthcare systems, the programme is expected to improve access to innovative medical technologies without compromising oversight.

Beyond administrative improvements, the pilot signals a growing trend of regional regulatory cooperation. By sharing review outcomes and building mutual trust, regulatory authorities can optimize resources, strengthen safety evaluation processes, and foster faster innovation in the medical device sector.

For manufacturers and distributors, this collaboration means smoother submissions and closer alignment of requirements across both countries. It also indicates a shift toward a more unified regulatory approach in Southeast Asia, which could pave the way for broader harmonization in the future.

As with any pilot, several aspects will be closely monitored. These include the degree of reliance given to prior approvals, how differences in device classification are managed, the documentation required for cross-country assessments, and the handling of accountability in the event of safety concerns.

Overall, this initiative marks a positive step for patients, healthcare providers, and the medical technology industry. It reflects a shared commitment to improving efficiency, strengthening cooperation, and enhancing timely access to safe medical devices in the region.

Source: Health Sciences Authority (HSA), Singapore & Medical Device Authority (MDA), Malaysia