Singapore’s Health Sciences Authority (HSA) has attained maturity level 4 (ML4) under the World Health Organization’s global benchmarking framework for medical devices, making it the first WHO Member State to reach this classification.

• Assessment: HSA evaluated using WHO’s Global Benchmarking Tool Plus for medical devices (GBT+MD).
• Scope: Confirms regulatory oversight from market authorisation and clinical evaluation to post-market surveillance.
• Impact: Supports continuous improvement and safeguards device safety, quality and performance throughout their life cycle.

Singapore hosts around 200 medical device manufacturers, spanning in vitro diagnostics to software as a medical device, and HSA participates actively in international regulatory harmonisation initiatives.

This summary is based on a news article by BioSpectrum Asia.

Image for illustrative purposes only. Source: Canva.