Singapore attains WHO’s ML4 classification for medical devices

• The World Health Organisation (WHO) announced today that Singapore’s Health Sciences Authority (HSA) has achieved the highest level of regulatory performance for medical devices under WHO’s global benchmarking framework.  

• Following a comprehensive assessment using WHO’s Global Benchmarking Tool Plus for medical devices (GBT+MD), HSA reached maturity level 4 (ML4), the highest classification in WHO’s system for national regulatory authorities overseeing medical products. 

• Singapore is the first WHO Member State to attain this level for medical device regulation.

• Singapore is a major global hub for medical technology innovation, with around 200 manufacturers producing a wide range of devices, from in vitro diagnostics to software as a medical device. 

• Singapore previously achieved WHO’s highest maturity level for medicines and imported vaccines regulation in 2022. 

• Regulatory authorities reaching ML4 may qualify as a WHO Listed Authority (WLA) after additional performance assessments — a designation recognising health regulators that can serve as reference authorities for other countries when making decisions about approving medical products. 

WHO’s Global Benchmarking Tool

• WHO Global Benchmarking Tool Plus for medical devices (GBT+MD) is an extension of WHO’s Global Benchmarking Tool, designed to assess and strengthen national regulatory systems for medical devices. 

• While based on regulatory principles common to other medical products such as medicines and vaccines, the GBT+MD addresses the specific challenges associated with regulating medical technologies. 

• The GBT incorporates the concept of ‘maturity level’ or ML (adapted from ISO 9004), allowing WHO and regulatory authorities to assess the overall ‘maturity’ of the regulatory system on a scale of 1 (existence of some elements of regulatory system) to 4 (operating at advanced level of performance and continuous improvement).

• WHO’s benchmarking framework evaluates regulatory authorities against more than 260 indicators covering key functions such as regulatory systems, product registration and market authorisation, laboratory testing, post-market surveillance, clinical trials oversight, regulatory inspections and licensing of establishments. 

• The assessment determines the maturity and functionality of national regulatory systems and supports their continuous improvement. 

• Globally, regulatory capacity remains uneven. Only 32 per cent of regulatory authorities worldwide have the capacity to fully ensure that medicines, vaccines and other health products meet required standards of safety, quality and effectiveness. 

• WHO benchmarking therefore helps identify areas for improvement towards establishment of stable, well-functioning and integrated regulatory systems in WHO Member States.

ML3 classification for India’s vaccine regulatory system

India’s Central Drugs Standard Control Organisation (CDSCO) operates at GBT Maturity Level 3 for vaccine regulatory system. This indicates a stable, well-functioning, and integrated regulatory system that meets international standards for vaccine production, licensing, and surveillance.