A lack of affordable, quality-assured medical equipment can severely impact an individual’s health status and push families into poverty through devastating out-of-pocket costs. An ecosystem that provides safe and affordable medical devices could be an important step forward in reducing these high costs.
A well-implemented regulatory framework will accelerate domestic production of medical products and ensure safe and affordable public distribution. However, complex regulatory processes and timelines can slow the introduction of new technologies. In the Asia-Pacific region, small and medium-sized enterprises with developing medical device manufacturing markets and primarily import-reliance often struggle to innovate due to high costs and regulatory complexity. Therefore, for the region’s medical device sector to realize its full potential, it is through stakeholder cooperation, global institutional initiatives, and cooperation between national regulatory authorities (NRAs) at different maturity levels. , these challenges need to be addressed. Increasing efforts to strengthen regulatory harmonization, convergence, and trust can play a catalytic role in conserving NRA resources and time, especially in public health situations of pressing concern.
Countries need to be prepared to develop and implement guidelines and pathways for emerging technologies such as software as medical devices (SaMD) and other AI-enabled digital health tools, and innovations in data storage and sharing. Conducting medical technology assessments can further advance policies regarding the introduction of new technologies. These efforts need to be integrated with existing efforts and built on global standards. Furthermore, to overcome the challenges of managing health care costs, especially in resource-constrained countries, regulations for medical device pricing need to be better defined, with appropriate considerations for maintaining incentives for innovation.
The Asian Development Bank (ADB) can play a role in helping countries in the region meet these challenges. By providing technical assistance, capacity building, and investments, ADB can help governments and NRAs modernize regulatory frameworks, promote integration with international standards, and make medical products more accessible and affordable. . ADB’s efforts to foster regional cooperation, seen through initiatives such as the Central Asia Regional Economic Cooperation (CAREC) Health Strategy, will promote regulatory harmonization among member countries and facilitate more efficient cross-border trade in medical equipment. and ensure faster access to lifesaving aid. Technology during a health crisis.
