Global experts and national regulators from the WHO South-East Asia Region came together to strengthen regulatory systems for medical devices, including in-vitro diagnostics and assistive devices, during a regional hybrid workshop hosted by the World Health Organization (WHO) in collaboration with the National Medicines Regulatory Authority (NMRA) of Sri Lanka.
Medical devices play a critical role in healthcare by enabling accurate diagnosis, effective treatment, and efficient rehabilitation. The five-day workshop, held from 17-21 February in Colombo, focused on advancing the safety, quality, and accessibility of medical devices, a key step toward achieving Universal Health Coverage (UHC) across the Region.
The workshop brought together national regulators from Bangladesh, Bhutan, India, Indonesia, Maldives, Sri Lanka, Thailand, and Timor-Leste, along with international experts from Japan’s Pharmaceuticals and Medical Devices Agency, Australia’s Therapeutic Goods Administration, and representatives from WHO headquarters, regional, and country offices. Participants collaborated to address regulatory challenges, share experiences and best practices, and develop strategies to ensure medical products meet international standards and improve healthcare outcomes.
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(Participants at the regional workshop in Colombo, Sri Lanka)
The Importance of effective regulatory systems
Effective regulatory systems are a vital component of strong healthcare frameworks, ensuring medical products are safe, effective, and accessible. Regulators play a critical role in maintaining these standards, contributing to improved public health outcomes and enhancing the quality of healthcare services. However, weak regulatory systems can become significant barriers, limiting access to essential medical devices, and compromising patient safety.
Regulating medical devices presents unique challenges compared to medicines and vaccines, given the vast range and complexity of products and the specialized expertise needed for their evaluation and assessment.
A recent survey from the South-East Asia Regulatory Network (SEARN) further showed that while a few countries in South-East Asia have well-established regulatory systems, others are still in the process of developing legal frameworks or have yet to fully implement existing provisions. These gaps underscore the need for a unified approach and capacity building to ensure medical device safety and accessibility.
Fostering regional collaboration through SEARN
WHO plays a pivotal role in supporting countries strengthen their regulatory systems and promote equitable access to high-quality, safe, effective, and affordable medical and health products.
Since 2016, the South-East Asia Regulatory Network (SEARN) established by the 11 Member States of the WHO South-East Asia Region has been instrumental in advancing regional collaboration, and convergence of regulatory practices in medical products. The network provides a platform for direct interaction among over 100 regulators, fostering a deeper understanding of the complex regulatory frameworks for medicines, vaccines, medical devices, and diagnostics. Through its meetings throughout the year and ongoing initiatives, SEARN actively supports countries in building regulatory capacity, sharing best practices, and aligning standards to enhance and protect public health across the Region and beyond.
The importance of such initiatives is underscored by a study from the Lancet Commission on Diagnostics, which found that only 19% of people in low- and lower-middle-income countries have access to basic diagnostic tests at the primary care level. In the WHO South-East Asia Region, the situation is even more challenging for assistive devices with just 10% of those needing assistive devices having access.
A Milestone for Healthcare Systems
Participants at the workshop engaged in discussions and developed strategies to enhance regulatory systems. They delved into the WHO Regulatory Systems Strengthening (RSS) Programme and the WHO Global Benchmarking Tool Plus for Medical Devices (GBT + MD), comparing national regulatory systems with international benchmarks for safety, quality, and effectiveness.
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(Participants exchange experiences and deliberate on strategies to strengthen safety and access to medical devices at the WHO regional workshop in Colombo, Sri Lanka)
A critical focus of the workshop was on developing effective models for market and post-market surveillance of medical devices, with particular attention to assistive devices. Participants highlighted the importance of maintaining the quality of assistive devices, addressing challenges such as limited public awareness about regulatory standards and the need to report issues to manufacturers or National Regulatory Authorities (NRAs). They also pointed out the current limited oversight of lower-risk medical devices, which may impact compliance with quality and manufacturing standards.
Participants also discussed emergency use authorizations (EUAs) for medical devices to boost preparedness and response capabilities, including for ongoing threats such as mpox.
“Access to quality medical devices-including in-vitro diagnostics and assistive devices-is a prerequisite for achieving Universal Health Coverage (UHC) and aligns with the WHO South-East Asia ROADMAP through reaffirming investment in vulnerable populations,” said Saima Wazed, Regional Director, WHO South-East Asia. She added, “This workshop will be a key milestone in strengthening the existing regulatory systems in the countries of South-East Asia. It is a much-needed beginning of what will be a long journey.”
Building a stronger healthcare system
The hybrid format of the workshop allowed for broader participation, combining in-person and virtual engagement to maximize learning and collaboration. At the conclusion of the event, participants had developed draft roadmaps for regulatory strengthening and identified specific areas where WHO and SEARN support would be critical.
As countries in the WHO South-East Asia Region continue to advance their regulatory systems, WHO remains a steadfast partner, providing technical guidance, sharing best practices, and supporting implementation strategies, including through acting as SEARN’s secretariat. The workshop reinforced ongoing efforts, building momentum for sustained progress and long-term benefits for healthcare systems and the communities they serve.