Since the launch of the Healthy Taiwan Cultivation Plan in 2024 under the broader national vision of “Healthy Taiwan,” strengthening healthcare system resilience and ensuring sustainable access to high-quality care have become central priorities in the healthcare policy agenda.

As global medical technology continues to evolve rapidly, ensuring the timely introduction of innovative medical devices is increasingly important for maintaining standards of care, protecting patient rights, and supporting the continued competitiveness of Taiwan’s healthcare sector. In this context, regulatory efficiency and predictable reimbursement pathways play a vital role in enabling Taiwan to keep pace with international medical innovation.

The Committee continues to focus on strengthening Taiwan’s regulatory framework for medical devices and enhancing the market’s attractiveness for innovative international technologies. To support these objectives, the Committee recommends optimizing the medical device registration and review framework, accelerating pre-market review timelines, and improving the transparency and pricing competitiveness of the National Health Insurance (NHI) reimbursement review process for medical devices.

Strengthening these mechanisms will help ensure timely patient access to innovative medical technologies while reinforcing the resilience of Taiwan’s medical technology supply chain in an increasingly complex global environment.

To facilitate more rapid clinical adoption of innovative medical technologies, the Committee emphasizes the importance of establishing forward-looking policy tools. These measures should include improving the fee management framework for medical devices that have received regulatory approval but are not yet covered by the NHI. Strengthening this framework would allow such products to enter the market and become available for patients’ out-of-pocket use soon after regulatory approval. The Committee also encourages the development of mechanisms to support the evaluation and diffusion of innovative medical technologies.

These reforms will help strengthen Taiwan’s attractive-ness as a priority market for the introduction of innovative international medical technologies while ensuring timely patient access to new and innovative medical devices. In light of these considerations, the Committee respectfully submits the following recommendations:

Suggestion 1: Enhance the medical device license registration framework to allow multiple global production sites under a single license.

The Committee acknowledges with appreciation the Taiwan Food and Drug Administration’s (TFDA) written response to our recommendation in the 2023 Taiwan White Paper to permit a single manufacturer to register multiple production sites for the same product under one license, provided that documentation on manufacturing processes and quality control is submitted. However, implementation of this policy since 2023 has been limited to kits and equipment with accessories, and has not been extended to single products.

To strengthen supply chain resilience, many companies operate multiple production lines across different countries using identical manufacturing processes to produce the same medical devices. The current policy regarding single products does not reflect the global reality of decentralized manufacturing networks and may create challenges for maintaining stable supply chains for medical devices when disruptions occur because of natural disasters, geopolitical events, material shortages, or capacity adjustments in the original source.

To address increasing global supply chain uncertainty, the Committee recommends adopting a flexible approach such as that currently applied to biologic drug licenses under Taiwan’s pharmaceutical regulatory framework. That approach allows the simultaneous listing of more than one manufacturing site. A similar framework for medical devices would permit manufacturers to register multiple production sites across different countries under the same product license when identical manufacturing processes and quality systems are used.

This change would better reflect current global manufacturing practices and strengthen supply chain resilience for medical devices. It would also enable healthcare institutions to switch quickly to alternative approved production sources in the event of supply disruptions, helping to maintain continuity of medical services and safeguard patient access to essential medical devices.

Suggestion 2: Advance alignment with international regulatory frameworks and otherwise transform Taiwan’s pre-market medical device review system..

The Committee commends the TFDA for studying the potential introduction of an international reliance review mechanism under which the TFDA would be able to reference regulatory decisions made by trusted international authorities. Such an initiative could significantly enhance the efficiency and predictability of medical device market authorization.

Reliance, recognition, and regulatory work-sharing approaches have become increasingly common internationally and are used in various forms across mature markets, including the United States, the European Union, Japan, and several ASEAN member states. Under a regulatory reliance framework, one country’s regulatory authority considers and gives significant weight to the scientific assessments, decisions, or inspection outcomes of another trusted regulatory authority. The World Health Organization has promoted this strategy Regulatory reliance is a principle whereby one regulatory authority considers and gives significant weight to the scientific assessments, decisions, or inspection outcomes performed by another trusted regulatory authority when making its own regulatory decisions. This approach is promoted by the World Health Organization (WHO) as a strategy to avoid duplication of work and facilitate faster access to quality, safe, and effective medical products.

A recognition system is a more formal process in which the regulatory authority accepts authorization by another trusted authority as evidence of compliance, often eliminating the need for independent review.

Our recommendation is that Taiwan adopt a flexible one-way reliance model that allows the TFDA to reference decisions made by trusted international regulatory authorities while retaining full authority over final approval decisions. Incorporating foreign review outcomes as reference, clarifying data requirements to avoid the need for repeated review, and establishing transparent and consistent review procedures would support the effective implementation of reliance mechanisms.

Taiwan may also consider introducing abridged review, verification, or partial review pathways that allow regulators to rely in part on prior reviews conducted by trusted international authorities, thereby facilitating greater alignment with international regulatory practices.

The following recommendations are proposed as foundational elements for the design and implementation of a future reliancebased premarket review framework, rather than as a general assessment of the existing regulatory system.

2.1   Issue clear and detailed regulatory and review guidelines. Clear guidance would enhance regulatory transparency and facilitate industry compliance.

2.2   Establish predictable and standardized review timelines. Predictable timelines would reduce regulatory uncertainty for manufacturers and support effective market planning.

2.3   Implement a phased approach, initially aligning with major mature regulatory authorities. Initial alignment could focus on the U.S. FDA, European Union regulatory authorities, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), followed by gradual expansion to other trusted agencies.

2.4   Strengthen post‑market surveillance mechanisms. The result would be sustained safety and performance following market entry.

2.5   Evaluate phased relaxation of Certificate of Free Sale or equivalent proof-of-sale requirements under a reliance-based framework. Adopting a reliance-based framework could eliminate delays in the review process caused by the traditional requirement for a “Certificate of Free Sale” or equivalent proof that the product is approved for manufacture and sale in the country of origin. The Committee recommends that the TFDA consider using such an approach to initiate the phased relaxation or elimination of proof-of-sale requirements, particularly for innovative medical technologies. Such adjustments would help facilitate more timely patient access to advanced medical devices while maintaining appropriate regulatory oversight.

These measures would reduce duplicative review requirements, improve regulatory efficiency, and enhance market predictability. Strengthening these mechanisms would also support Taiwan’s competitiveness and help align its regulatory framework with international best practices.

Suggestion 3: Enhance transparency and predictability in the NHI medical device reimbursement review process.

3.1   Upgrade the NHIA online platform for tracking the status of new functional medical device reimbursement applications to improve transparency and case tracking. The Committee recommends that the National Health Insurance Administration (NHIA) upgrade the current online tracking platform by benchmarking the system standards adopted by the TFDA. In addition to updating case review histories, the platform could disclose real-time case status, anticipated review steps, and indicative timelines. Greater transparency would provide healthcare institutions with a reliable reference point and reduce the administrative burden associated with responding to case-by-case inquiries.

We further urge the NHIA to provide applicants with the minutes of expert review meetings, together with the preliminary review results for new medical devices. Providing such documentation would support the government’s objective of strengthening information transparency. Improved access to review information would allow patient groups, industry stakeholders, and other relevant parties to better understand the review process and facilitate the introduction of innovative medical technologies through greater predictability.

3.2   Increase transparency in the review scheduling and evidence update process for non-reimbursed medical devices. For certain new functional medical devices not yet covered by the NHI, applicants often need to wait several years after submission before their cases enter the Health Technology Assessment (HTA) phase. As a result, the clinical evidence originally submitted may be outdated by the time the review begins, no longer reflecting the device’s most recent clinical value and safety profile.

To align with sound international regulatory practices, we recommend that the NHIA publicly disclose the review schedule for non-reimbursed medical devices at least one year in advance. Early communication would allow applicants, hospitals, and medical societies to prepare updated clinical evidence prior to the start of the HTA review.

We further recommend revising the current NHIA operational guidelines for health technology assessment of special materials by adopting an approach similar to that used for Health Technology Reassessment (HTR). Applicants could be allowed to submit the most up-to-date clinical evidence before the HTA review formally begins, thus improving the completeness of HTA evaluations and helping reduce delays in patient access to innovative medical technologies available internationally.

Suggestion 4: Allow hospitals to charge for newly approved medical devices before NHI reimbursement is completed.

Although the NHIA has stated that self-pay medical devices fall outside its jurisdiction, hospitals in practice continue to follow the operational guidelines and related official correspondence issued by the NHIA when managing such devices.

At the same time, Article 21 of the Medical Care Act designates the Department of Medical Affairs under the Ministry of Health and Welfare and local health bureaus as the competent authorities for the supervision of medical institutions. This situation creates inconsistencies between the statutory regulatory framework and practical compliance requirements for healthcare providers.

While the NHIA’s operational guidelines are administrative in nature, hospitals commonly rely on them in practice to reduce audit risks. This reliance has contributed to differences between statutory authority and operational practice, resulting in limited transparency and inconsistent management standards for self-pay medical devices.

To enhance regulatory coherence and improve predict-ability in the clinical adoption of new medical technologies, we recommend that the Department of Medical Affairs, in accordance with its authority under Article 21, consolidate existing regulations and issue formal guidance on the management of self-pay medical devices. Clear guidance would provide medical institutions with a consistent regulatory framework for operational compliance.

We further recommend that local health bureaus conduct inspections in accordance with the Medical Care Act. Aligning supervisory practice with the statutory allocation of responsibilities would improve transparency, strengthen administrative efficiency, and support more predictable access to innovative medical technologies.

Suggestion 5: Establish an NHI sandbox mechanism for imported innovative technologies and create a Taiwan Medical Innovation Acceleration Fund.

Given the limited availability of NHI global budget, innovative and resilient mechanisms need to be adopted for introducing new medical technologies into the Taiwan market:

5.1   Adopt a reimbursement pricing methodology that reflects real market conditions for new medical devices. To maintain Taiwan’s global competitiveness in medical technology and sustain clinical innovation, we recommend adopting a reimbursement pricing approach that is aligned with international practice. For new medical devices, reimbursement prices should reference actual procurement prices in hospitals, as well as the prices at which patients obtain these devices in the market. Such an approach would help ensure fair pricing, maintain supply stability, and support the continued introduction of innovative medical devices into Taiwan.

When international prices are used as references, the pricing methodology should also account for market size and each country’s medical technology expenditure as a percentage of GDP. Incorporating these factors would provide a more accurate reflection of market conditions and reduce the risk of systemic undervaluation that can limit patient access to innovative technologies.

5.2   Provide an NHI sandbox mechanism that includes imported innovative medical devices. For innovative medical devices that demonstrate clinical potential and have received regulatory approval overseas but may face delays in obtaining NHI coverage, the Committee proposes establishing an NHI sandbox mechanism that allows the continued collection of real-world evidence from Taiwanese patients. Such a mechanism would help address urgent clinical needs while enabling the NHIA to make evidence-based decisions on pricing and reimbursement.

At present, policy discussions and pilot programs related to an NHI sandbox have primarily focused on domestically developed medical innovations. Expanding such mechanisms to include imported innovative technologies would better reflect the global nature of medical technology development and improve Taiwan’s ability to respond to rapid advances in healthcare innovation. Allowing early clinical use together with parallel evidence generation would support more timely patient access while strengthening the evidence base for reimbursement decisions.

5.3   Establish a Taiwan Medical Innovation Acceleration Fund to support early clinical adoption and evaluation of innovative technologies. To further reduce delays associated with reimbursement approval, we recommend establishing a Taiwan Medical Innovation Acceleration Fund with dedicated annual funding to support innovative care models and health services research. Such a fund could facilitate the clinical adoption and evaluation of emerging medical technologies and strengthen Taiwan’s position within the global healthcare innovation ecosystem.