Esteemed Hosts from the Government of Sri Lanka, distinguished Guests from national regulatory authorities
Esteemed experts from the Pharmaceuticals and Medical Devices Agency of Japan and the Therapeutic Goods Administration of Australia
Colleagues from WHO headquarter, country offices and Regional Office,
Welcome to Colombo for this Regional hybrid workshop to improve the regulation of medical devices.
First, I would like to extend my thanks to the National Medicines Regulatory Authority of Sri Lanka for hosting this gathering. Sri Lanka has recently made excellent progress towards strengthening its regulatory system, including medical devices, with the full engagement of the Government of Sri Lanka. This is evident in the excellent decision of NMRA to organize the first assisted self-assessment of the risk of corruption. There is no doubt that this will serve as inspiration not just in our South-East Asia region, but beyond as well. I am pleased that UNODC and WHO are partners in this.
Sri Lanka has also been an active member of the South-East Asia Regulatory Network (SEARN). You have not only participated in the steering group but have also chaired the Mpox ad hoc working group since October. I thank you for being such and active, engaged and valuable part of our community.
Access to medical devices - including in-vitro diagnostics and assistive devices - is a prerequisite for achieving Universal Health Coverage (UHC). The Lancet Commission on Diagnostics estimated that only 19% of people in low- and lower-middle-income countries have access to the simplest of diagnostic tests at the primary care level. Only 10% of the population needing assistive devices has access to it, and the gap is even wider in our South-East Asia region.
However, the regulation of medical devices has unique challenges compared to medicines and vaccines. This is because of the very large number and diversity of products, and the range of expertise required to assess these.
It is most fortunate that the finalization of the WHO Global Benchmarking Tool Plus Medical Devices (GBT+MD), in December 2024, coincided with this request from SEARN to organize this workshop during the 2024-2025 work plan.
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, and I am certain you are all pleased to finally start it.
At the end of this week, you will have developed your draft roadmaps towards strengthening your regulatory systems and would have identified the support required. You will also discuss how the current SEARN strategies dedicated to medical devices can support you in these efforts.
This workshop shows the commitment of WHO to give the regulation of these life-enabling and life-saving products long deserved attention.
I wish each of you a fruitful and productive workshop. I urge you all to actively engage and contribute and learn from the experience of each other and from our esteemed experts.
I look forward to being briefed of the outcomes. Be reassured that WHO stands with you and supports your endeavours.
Thank you.