Scaling Medical Devices in Asia and the Pacific Through Stronger Regulations, Greater Harmonization

The market for medical devices in the Asia-Pacific region is projected to reach a 7.3% compound annual growth rate from 2023 to 2030. Medical device companies further contribute 2% to the region’s gross domestic product, according to the Asia Pacific Medical Technology Association. Two major drivers seen to sustain this momentum are technological advancements and a strengthened regulatory ecosystem, which includes harmonization of standards and conformity to assessment procedures.

However, Asia and the Pacific economies differ significantly with respect to the maturity level of their National Regulatory Authorities (NRAs). Australia, Japan, and Singapore have well-established, globally benchmarked regulatory bodies, while other countries like India are evolving to meet the growing market demands on performance, safety and efficacy. At the other end of the spectrum, Brunei, Georgia, Mongolia, Timor-Leste, and other low- and middle-income countries (LMICs) either lack a national regulatory authority (in which case the Ministry of Health oversees regulation for medical devices) or have NRAs with limited capacity.

In general, countries categorize medical devices based on risk to humans but with varying number of levels or classes. Under a risk-based classification system, an increasing level of regulation is applied as the potential risk rises. Depending on the country, medical device regulations may include registration, licensing, and in-country testing, among others.

Rapid technological advancements and globalization of the medical device sector necessitates the harmonization of regulations beyond national boundaries.

In the Asia–Pacific region, regulatory harmonization is critical because of the large and growing population base, differential economic growth, and significant differences in the maturity of National Regulatory Authorities. Further, as more countries enter into multi- or bilateral trade agreements, harmonization can help reduce the non-tariff and compliance aspects of negotiations and support trade for medical devices. Toward this endeavor, Australia’s Therapeutic Goods Administration and Japan’s Pharmaceuticals and Medical Devices Agency, along with the PRC’s National Medical Products Administration, have long been members of the International Medical Device Regulators Forum (IMDRF). Additionally, ROK’s Ministry of Food and Drug Safety, and India’s Central Drugs Standard Control Organization have been taking considerable steps toward harmonization with internationally benchmarked regulations. The later recently joined the IMDRF as an affiliate member.

Singapore and Japan have been emerging as “reference countries” for regulatory reliance. During the COVID-19 pandemic, the Thai Food and Drug Administration set a successful example by evaluating the devices based on safety assessment and performance results from Singapore’s Health Sciences Authority, which led to the establishment of a formal regulatory reliance pathway between Singapore and Thailand, the first of its kind in the region.

Another successful example, the Philippines implemented a program to encourage regulatory reliance within the Association of Southeast Asian Nations (ASEAN). With Singapore, Thailand, Indonesia, and Malaysia, it leveraged abridged pathways for submission of medical device information to support faster approval processes. Viet Nam has also expanded its abridged pathway and added the Ministry of Food and Drug Safety of ROK and National Medical Products Administration of the PRC as reference markets for expediting review and approval. Provisions to harmonize medical device regulations in the region are also within the scope of the ASEAN Medical Device Directive established in 2015.

At the global level, WHO supports Good Reliance Practices to optimize resources and expertise available; facilitate timely access to safe, effective, quality-assured medical products; and support regulatory preparedness and public health response especially during emergencies. In 2023, the United States Food and Drug Administration also released a draft of the Center for Devices and Radiological Health (CDRH) International Harmonization Strategic Plan. It describes specific strategies to encourage regulatory harmonization, convergence, and reliance for medical devices among the regulatory authorities, as applicable. Meanwhile, the European Medicines Agency regulates conformity assessment, a requirement for manufacturers tasked with placing a Conformité Européenne (CE) mark on products sold in the European Economic Area.

Lack of affordable and quality assured medical devices severely impact the health outcomes of individuals and can push families into poverty due to catastrophic out-of-pocket expenditures. An ecosystem conducive to safe and affordable medical devices can be a significant step forward toward reducing such high costs.

A well-executed regulatory framework can accelerate domestic production of medical products and ensure their public distribution in a safe and affordable manner. However, complicated regulatory processes and timelines can delay the introduction of new technologies. In Asia and the Pacific, the developing medical device manufacturing market and the LMICs that depend primarily on imports often struggle in innovation due to high costs and regulatory complexities. Thus, for the region’s medical device sector to fully achieve its potential, these challenges need to be addressed through stakeholder cooperation, efforts of global agencies, and collaborations between the National Regulatory Authorities (NRAs) of different maturity levels. Increased efforts to strengthen regulatory harmonization, convergence, and reliance can play a catalytic role in saving the resources and time of the NRAs, especially in public health situations of immediate concern.

Country readiness is needed to formulate and implement guidelines and pathways for emerging technologies, including Software as a Medical Device (SaMD) and other AI-enabled digital health tools and innovations in data storage and sharing. Undertaking health technology assessments can further guide policies on the adoption of new technologies. These endeavors should integrate with existing efforts and build on global standards. Additionally, regulations in medical device pricing vis-à-vis due consideration to maintaining incentives for innovation need to be better defined to overcome the challenges of managing healthcare costs, especially in resource-constrained countries.

Asian Development Bank (ADB) can play a role in helping countries in the region address these challenges. By providing technical assistance, capacity building, and investment, ADB can support governments and NRAs in modernizing their regulatory frameworks, facilitating convergence with international standards, and ensuring that medical products are both accessible and affordable. ADB's efforts to foster regional cooperation, as seen through initiatives like the Central Asia Regional Economic Cooperation (CAREC) Health Strategy, can promote regulatory harmonization across member countries, enabling more efficient cross-border trade in medical devices and ensuring faster access to life-saving technologies during health crises.

The Sustainable Development Goal 3 strives to achieve health and well-being for all by 2030. In particular, Target 3.8 aims to achieve Universal Health Coverage that includes access to quality health services, along with safe, effective, and quality medicines and health products. However, according to the Lancet Commission report (2021), 47% of the world's population has little to no access to diagnostics. The report also stated that reducing this gap, particularly for the six tracer conditions, to at least 10% could lead to significant reduction in the annual number of premature deaths and annual disability-adjusted life-year in LMICs. A strong and interoperable regulatory framework and harmonized standards can strengthen the market for medical devices including in vitro diagnostics and help ensure that new technologies benchmarked for clinical performance and patient safety are accessible to all, while saving the resources of National Regulatory Authorities.

Note: This work is supported by ADB Regional Technical Assistance: Strengthening Integrated Primary Health Care Management of Noncommunicable Diseases (Project 56072-001/TA10106) and part of a conference Bridging Gaps for Noncommunicable Diseases (NCDs) and Mental Health: Leveraging Technology Innovations for Impact (18–20 June 2024, ADB Manila). The authors team wishes to thank Dr. Dinesh Arora, ADB Principal Health Specialist, whose comments helped improve the article. PATH acknowledges Dr. Saahil Khandelwal for his contribution in scoping market information and developing the infographic for the article.

B. Banga. 2024. Asia’s Changing Medical Device Landscape: Navigating Regulations and Trends. Medical Technology.

International Medical Device Regulators Forum. GHTF Archives.

M. Xu et al. 2022. Regulatory Reliance for Convergence and Harmonisation in the Medical Device Space in Asia-Pacific. BMJ Global Health. 7: 8.

Statista Research Department. 2024. Total Sales Value of the Medical Device Market in the Asia-Pacific Region from 2018 to 2022, with Forecasts Until 2030.

World Health Organization. 2024. WHO Health Topics: Medical Devices.

WHO Expert Committee on Biological Standardization. 2023. WHO Global Model Regulatory Framework for Medical Devices Including In Vitro Diagnostic Medical Devices, Annex 3. WHO Technical Report Series.