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The importance of Health technology assessment (HTA) in influencing the assessment, approval, and adoption of medical devices in healthcare systems is increasingly being realised, particularly in the Asia Pacific (APAC) region.(1) Unlike pharmaceuticals where HTA frameworks are comparatively mature and globally consistent, HTA for medical devices poses unique challenges with their rapid innovation cycles, shorter lifespans, iterative design developments, and requirement of user training and system readiness. These challenges make their evaluation complicated, yet increasingly important, as policymakers must assess technological progress with fair access and sustainable healthcare expenditure.(1-3) 

The APAC is a region known for its huge diversity, ranging from high-income countries with well-established health systems to developing countries with limited resources and vast unmet clinical needs.(4) This diversity necessitates distinct HTA methodologies. For instance, countries like Australia, South Korea, Japan have HTAs well-integrated into reimbursement and procurement decisions,(2, 5-9) while others like India, Thailand, and the Philippines are still developing institutional guidance and capability. Middle-income countries usually only barely focus on costs and limit coverage of new innovations, while higher-income countries use HTA to improve both cost and utilization, largely encouraging broader coverage if technologies meet clinical and economic criteria.(10) As a result, HTA practices in the APAC region are variable, ranging from highly organized systems to emerging models just beginning to incorporate evidence-based assessments into policy decisions.(3, 4)  

Medical devices are dynamic and context-sensitive, which makes real-world evidence (RWE), as well as data from local health registries and pragmatic trials, particularly important. In addition, differences in infrastructure, cultural backgrounds, and epidemiological patterns may hinder the applicability of evidence across healthcare settings.(2-4) 

In the APAC region, South Korea requires medical technologies seeking reimbursement to undergo HTA evaluation by the Health Insurance Review and Assessment Service (HIRA), while also using approaches like conditional approval, rapid review, and coverage with evidence development to balance timely access with rigorous evaluation.(5) In Australia, HTA evaluations for medical devices are performed by the Medical Services Advisory Committee (MSAC), requiring systematic reviews and pharmacoeconomic evidence but also often apply alternative strategies, like linked evidence approaches, when randomized trials are unfeasible, while also taking into account equity and ethical concerns along with cost-effectiveness.(6, 7) 

In contrast, Japan has a unique model with medical device reimbursement heavily reliant on comparisons with available functional categories or cost-calculation approaches.(8) Japan’s HTA process (since 2019) necessitates cost-effectiveness analysis for expensive devices, with price cuts upon failure to demonstrate value. (8, 9) Other APAC countries, including China, India, Thailand, and Indonesia, are in earlier stages of HTA for medical devices, primarily emphasizing cost containment and limited coverage, but are gradually evolving towards guidance adapted to local healthcare needs and increasing regional collaboration.(2-4) 

By integrating context-specific considerations, HTA frameworks in the APAC region are expected to go beyond narrow cost-control strategies to achieve tactical investments in technologies that truly cater to the local preferences, sustainability, and equitable access.(3, 4) The future of medical device HTA in APAC region warrants collective and adaptive strategies, including digital therapeutics and AI-powered diagnostics, with many countries beginning to implement these advances in their evaluations. Initiatives like HTAsiaLink are also instrumental in promoting knowledge-sharing and avoiding effort duplication, while global partnerships and capacity-building programs continue to support local expertise.(11) With countries investing in data networks, standardizing approaches, and focusing on fair access, HTA will continue to guide decisions on reimbursement and procurement, thus shaping innovation that aligns with the health preferences of diverse populations across the region. 

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References 

1. Liu G, Wu EQ, Ahn J, Kamae I, Xie J, Yang H. The Development of Health Technology Assessment in Asia: Current Status and Future Trends. Value Health Reg Issues. 2020; 21:39-44. 
2. Shiroiwa T, Fukuda T, Ikeda S, Takura T, Moriwaki K. Development of an Official Guideline for the Economic Evaluation of Drugs/Medical Devices in Japan. Value Health. 2017; 20(3):372-378. 
3. Bhattacharyya D. HTA of Medical Devices in Asia Pacific. ISPOR Asia Pacific 2018. [Accessed online on 5th September 2025]. Available online at: https://www.ispor.org/docs/default-source/conference-ap-2018/hta_of_medical_devices_in_asia_pacific_devarshi.pdf?sfvrsn=b71c1b82_0 
4. Kao C, Lakhanpal S. Health Technology Assessment (HTA) for Medical Devices in Asia Pacific – Webinar Summary. APACMed – Avalere Health. [Accessed online on 5th September 2025]. Available online at:  https://apacmed.org/wp-content/uploads/2024/04/HTA-for-medical-devices-in-Asia-Pacific_FINAL.pdf 
5. Oh J, Kim MJ, Hur S, Oh J, Kim DS. Institutionalizing Health Technology Assessment and Priority Setting in South Korea’s Universal Health Coverage Journey. Health Systems & Reform. 2023; 9(3). 
6. Hill H, Mittal R, Merlin T. Evidence-based funding of new imaging applications and technologies by Medicare in Australia: How it happens and how it can be improved. J Med Imaging Radiat Oncol. 2022; 66(2):215-224. 
7. Centre for Health Economics Research & Evaluation (CHERE) – University of Technology, Sydney. Health Technology Assessment Policy and Methods Review: HTA Methods: Economic Evaluation. [Accessed online on 8th September 2025]. Available online at:  https://www.health.gov.au/sites/default/files/2024-07/hta-policy-and-methods-review-hta-methods-economic-evaluation.pdf 
8. Tamura M, Nakano S, Sugahara T. Reimbursement pricing for new medical devices in Japan: Is the evaluation of innovation appropriate? Int J Health Plann Manage. 2019; 34(2):583-593. 
9. Hasegawa M, Komoto S, Shiroiwa T, Fukuda T. Formal Implementation of Cost-Effectiveness Evaluations in Japan: A Unique Health Technology Assessment System. Value Health. 2020; 23(1):43-51. 
10. Alkhaldi M, Al Basuoni A, Matos M, Tanner M, Ahmed S. Health Technology Assessment in High, Middle, and Low-income Countries: New Systematic and Interdisciplinary Approach For Sound Informed-policy Making: Research Protocole. Risk Manag Healthc Policy. 2021; 14:2757-2770. 
11. HTAsiaLink. [Accessed online on 5th September 2025]. Available online at: https://htasialink.com/about-us