Laily UPN
The 2024 launch of the Healthy Taiwan Cultivation Plan has signaled a transformative era for the nation’s healthcare landscape, placing the concepts of system resilience and sustainable access to high-quality care at the forefront of the government’s agenda. As part of a broader national vision championed by the current administration, the policy seeks to bridge the gap between Taiwan’s clinical standards and the rapid evolution of global medical technology. However, industry experts and regulatory committees are now signaling that for this vision to succeed, Taiwan must urgently address structural bottlenecks in its medical device registration and reimbursement frameworks.
To maintain its standing as a regional leader in healthcare, Taiwan is facing increasing pressure to optimize its regulatory efficiency and create more predictable pathways for market entry. The current climate, characterized by rapid innovation in digital health, precision medicine, and minimally invasive technologies, requires a regulatory environment that can keep pace with international standards. Without these reforms, there are growing concerns that Taiwanese patients may face significant delays in accessing life-saving technologies, while the nation’s healthcare sector could see a decline in its international competitiveness.
Strengthening Supply Chain Resilience through Regulatory Flexibility
One of the primary concerns raised by industry stakeholders involves the rigidity of the current medical device licensing system. In a post-pandemic world, global manufacturers have increasingly shifted toward decentralized manufacturing networks to mitigate risks associated with natural disasters, geopolitical instability, and material shortages. Despite these global shifts, Taiwan’s regulatory framework for single medical products remains tethered to a model that often restricts a license to a specific production site.
In 2023, the Taiwan Food and Drug Administration (TFDA) took a step toward flexibility by allowing a single manufacturer to register multiple production sites for kits and equipment with accessories under one license. While this move was welcomed, it has not yet been extended to single products. For many multinational medical technology firms, this creates a significant hurdle. These companies often utilize identical manufacturing processes and quality control systems across different countries to ensure a stable global supply.
The Committee advocating for these changes suggests that Taiwan should adopt a model similar to its own pharmaceutical regulatory framework for biologic drugs, which allows for the simultaneous listing of multiple manufacturing sites. By permitting manufacturers to register multiple global production lines under a single license for the same product, Taiwan could significantly enhance its supply chain resilience. This would allow healthcare institutions to quickly pivot to alternative approved sources during a supply chain disruption, ensuring that essential medical services remain uninterrupted and patient safety is not compromised.
Aligning with Global Standards through Regulatory Reliance
The concept of "regulatory reliance" has become a cornerstone of modern medical device oversight, promoted by the World Health Organization (WHO) as a means to avoid the duplication of work and accelerate access to safe medical products. Under this model, a national regulatory authority considers the scientific assessments and decisions of trusted international peers—such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)—when making its own authorization decisions.
While the TFDA has begun studying the potential for an international reliance review mechanism, stakeholders are calling for a more formal and expansive adoption of this strategy. Currently, the medical device review process in Taiwan can be redundant, requiring manufacturers to resubmit extensive data that has already been rigorously vetted by other major global authorities.
The proposed "one-way reliance model" would allow the TFDA to reference foreign review outcomes while retaining final approval authority. This approach would not only improve the efficiency of the pre-market review timeline but also enhance market predictability. Stakeholders recommend a phased implementation, starting with alignment with mature regulatory bodies in the U.S., EU, and Japan, followed by a gradual expansion. Furthermore, there is a strong push for the TFDA to relax or eliminate the requirement for a "Certificate of Free Sale" (CFS) for innovative technologies, as this traditional requirement often causes unnecessary delays for products that are already proven safe in other advanced markets.
Enhancing Transparency in the National Health Insurance (NHI) Process
While regulatory approval is the first step, the second—and often more difficult—hurdle is securing reimbursement under Taiwan’s National Health Insurance (NHI) system. The NHI is the backbone of Taiwan’s healthcare, covering over 99% of the population, but its reimbursement review process for new medical devices has been criticized for a lack of transparency and predictability.
Currently, the National Health Insurance Administration (NHIA) operates an online platform for tracking applications, but industry members argue it lacks the real-time detail necessary for effective planning. There is a call to upgrade this platform to match the standards of the TFDA, providing applicants with real-time status updates, anticipated review steps, and indicative timelines. Furthermore, providing applicants with the minutes of expert review meetings would offer much-needed clarity on why certain decisions are made, allowing for a more collaborative approach to introducing new technologies.
A significant issue also exists regarding non-reimbursed medical devices. Applicants often wait several years for a Health Technology Assessment (HTA), by which time the clinical evidence submitted at the start may be obsolete. To address this, stakeholders recommend that the NHIA disclose review schedules at least one year in advance. This would allow hospitals, medical societies, and manufacturers to prepare the most up-to-date clinical value and safety data, ensuring that evaluations are based on the latest medical science.
Bridging the Gap between Statutory Authority and Hospital Practice
A peculiar regulatory disconnect has emerged regarding "self-pay" medical devices—products that have received regulatory approval but are not yet covered by the NHI. Under Article 21 of the Medical Care Act, the Department of Medical Affairs and local health bureaus are the designated authorities for supervising medical institutions. However, in practice, hospitals often look to the NHIA for guidance on how to manage and charge for these devices to avoid audit risks.
This administrative ambiguity has led to inconsistent management standards across different regions and institutions. To resolve this, there is a recommendation for the Department of Medical Affairs to consolidate existing regulations and issue formal, unified guidance on the management of self-pay medical devices. By aligning supervisory practices with the statutory allocation of responsibilities, the government can provide medical institutions with a consistent framework, thereby improving transparency and ensuring that patients have more predictable access to the latest medical tools.
The Role of Innovation Funds and the "NHI Sandbox"
Perhaps the most forward-thinking recommendation involves the creation of an "NHI Sandbox" and a dedicated "Taiwan Medical Innovation Acceleration Fund." As the NHI global budget faces increasing pressure from an aging population and rising healthcare costs, traditional reimbursement models may no longer be sufficient to support the entry of high-cost, high-impact innovations.
The proposed sandbox mechanism would allow imported innovative medical devices—not just those developed domestically—to enter the market under a controlled environment. During this period, the NHIA could collect real-world evidence (RWE) from Taiwanese patients to determine the device’s clinical efficacy and cost-effectiveness. This evidence-based approach would allow for more informed pricing decisions while providing patients with early access to breakthrough treatments.
To complement this, a Taiwan Medical Innovation Acceleration Fund would provide dedicated annual funding to support early clinical adoption and health services research. This fund would act as a bridge, reducing the financial risk for hospitals and ensuring that Taiwan remains a priority market for global medical technology innovators.
Chronology of Reform Efforts and Future Implications
The push for these reforms did not emerge in a vacuum. It is the result of years of advocacy and a series of white papers that have highlighted the growing gap between Taiwan’s regulatory speed and global innovation cycles.
- 2023: The TFDA responds to industry feedback by allowing multiple production sites for kits and equipment, a move that set the stage for current discussions on expanding this to all medical devices.
- Early 2024: The launch of the Healthy Taiwan Cultivation Plan provides the political impetus to rethink healthcare resilience and patient rights.
- Mid-2024: Stakeholders submit formal recommendations to the government, emphasizing the need for regulatory reliance and NHI transparency.
The implications of these proposed changes are profound. For patients, the reforms mean faster access to advanced diagnostics, robotic surgeries, and personalized implants. For the government, it means a more resilient healthcare system capable of weathering global supply shocks. For the economy, it reinforces Taiwan’s reputation as a "biotech island," attracting foreign investment and fostering a more vibrant medical technology ecosystem.
As the government evaluates these suggestions, the focus remains on the ultimate goal: ensuring that the "Healthy Taiwan" vision is not just a policy statement, but a lived reality for every citizen. By modernizing the regulatory and reimbursement landscape, Taiwan has the opportunity to turn its healthcare challenges into a blueprint for international excellence in medical innovation.
Nana Wu
Layla Zulfa
