This year Taiwan marks the 15th anniversary of the Taiwan Food and Drug Administration (TFDA), the 30th anniversary of the National Health Insurance (NHI) system, and the first anniversary of the Healthy Taiwan policy initiative. These milestones underscore the government’s steadfast commitment to the “Health for All” vision of the World Health Organization (WHO). By strengthening alignment with international standards and accelerating the adoption of innovative medical technologies, Taiwan continues to build healthcare resilience and reinforce its healthcare system as a pillar of public wellbeing.

The Committee remains focused on improving the speed and predictability of regulatory approval and market access for new medical devices manufactured abroad. As the global healthcare sector becomes increasingly interconnected, Taiwan’s compact yet highly advanced medical market must retain its international competitiveness by maintaining a flexible regulatory framework, transparent and sustainable NHI reimbursement mechanisms, and clearly defined pathways for the introduction of novel medical technologies under self-pay models.

These elements are essential for ensuring that Taiwan remains a preferred market for launching innovative medical solutions that benefit patients and strengthen healthcare outcomes. In light of these considerations, the Committee makes the following recommendations:

Suggestion 1: Streamline the Quality System Documentation review process and clarify the definition of manufacturers under the Medical Devices Act.

The Medical Devices Act, which came into effect on May 1, 2021, offers more detailed definitions of manufacturers and manufacturing processes than the preceding Pharmaceutical Affairs Act did for medical devices. However, this additional specificity has brought interpretive inconsistencies in implementation. To facilitate the timely introduction of innovative medical devices, the Committee suggests the following changes:

1. Align Quality System Documentation (QSD) requirements with Article 10 of the Medical Devices Act.
   For imported medical devices, QSD applications are required to demonstrate compliance with quality management system operations, including design, manufacturing, packaging, labeling, sterilization, and final product release. In practice, divergent interpretations by the TFDA’s Division of Quality Compliance and Management and the Division of Medical Devices and Cosmetics have led to approval content that is misaligned with subsequent product registration requirements. Under the current regulatory framework, there are two types of qualifications eligible to apply for a QSD license: design and final inspection, or actual manufacturing, labeling, and final inspection and release. Article 10 of the Medical Devices Act does not require these two qualification types to be combined. Each qualification represents a distinct function within the manufacturing process, and companies should be permitted to apply for QSD certification based on the scope of their actual responsibilities.
   To ensure consistency and reduce administrative delays, the Committee recommends aligning QSD documentation requirements with Article 10 of the Medical Devices Act. Specifically, we recommend grouping activities such as manufacturing, packaging, labeling, sterilization, and product release under a single category and treating design and market distribution functions separately.
   Additionally, a more flexible interpretation of the term “manufacturer” under Article 10, Paragraph 1 (recognizing that the company making the product is not always the one responsible for its final approval) would better reflect current industry practice regarding delegated operations.
2. Extend review streamlining to include all Medical Device Single Audit Program (MDSAP) countries.
   MDSAP is an international program that allows a single audit to satisfy the quality system requirements of multiple regulatory authorities, helping to reduce duplication and speed up approval processes. Since 2021, the Ministry of Health and Welfare has accepted audit reports from MDSAP to streamline QSD reviews for medical devices manufactured in certain territories, such as the United States. Considering that Taiwan became an affiliate member of MDSAP in 2023, the Committee recommends extending this recognition to all MDSAP member countries and to subsidiary manufacturers of U.S.-based companies holding MDSAP audit reports. This expansion would reduce duplicative regulatory burdens and promote alignment with international best practices.

Suggestion 2: Streamline Certificate to Foreign Government and Certificate of Free Sale requirements to support timely product registration and launch.

Under current regulations, medical device registration in Taiwan requires submission of a Certificate to Foreign Government (CFG) or Certificate of Free Sale (CFS) issued by the competent authority of the country of origin, unless otherwise exempted by the TFDA. This requirement delays Taiwan’s product registration timeline, as applicants must first obtain approval in the originating market or other jurisdictions before initiating the TFDA review process. The resulting time lag weakens Taiwan’s potential as a priority launch destination within Asia and limits timely access to medical innovations for healthcare professionals and patients.

While the Committee has previously recommended waiving the CFG/CFS requirement in line with practices observed in other Asia-Pacific markets, the TFDA has maintained that submission of such certificates remains necessary. In light of this position, the Committee proposes the following procedural enhancements to improve efficiency and minimize delays:

1. Accept electronic CFGs or CFSs with verifiable authenticity in lieu of requiring legalized hard copies.
   This approach would align with global regulatory trends and reduce administrative burdens for both applicants and authorities.
2. Permit applicants to submit alternative documentation.
   Such documentation, to be submitted at the preliminary screening stage, could include proof of regulatory approval in another jurisdiction, with the CFG or CFS to be provided prior to final registration approval. This adjustment would enable the TFDA to begin its review without requiring full documentation upfront, thus accelerating time-to-market.
3. Exempt CFG/CFS submission during the license renewal process for products already approved in Taiwan.
   This exemption should be in place provided that the manufacturer’s quality management system remains valid and the medical device file confirms continued production. Given that manufacturing licenses are renewed every three years and updated documentation is already required, this exemption would avoid unnecessary duplication while ensuring that regulatory oversight remains intact.

Suggestion 3: Facilitate timely access to innovative medical devices in NHI-contracted hospitals.

Under current procedures, when license holders seek to introduce a newly approved medical device into an NHI-contracted hospital, they are required to provide a “reimbursement status review certificate” in accordance with the guidelines for non-reimbursed medical devices and Article 14 of the “Regulations Governing Contracting and Management of National Health Insurance Medical Care Institutions.” However, in practice, many innovative devices encounter significant delays in obtaining reimbursement status due to the complexity of product classification, pricing mechanisms, and multi-stakeholder involvement. This results in uncertainty and postpones clinical access to needed technologies.

The Committee urges the government to uphold and enhance real-time transparency in the reimbursement review process for new functional medical devices via the National Health Insurance Administration (NHIA) tracking system. Timely public disclosure of review status, milestones, and full decision history is essential to support healthcare providers in offering self-pay options in accordance with the Medical Care Act. Transparency at each stage of the review process allows physicians and patients to make informed clinical decisions and facilitates earlier access to innovative medical technologies prior to formal inclusion in the NHI reimbursement system.

Suggestion 4: Accelerate the implementation of evidence-based differential payment mechanisms for special medical devices in alignment with the Healthy Taiwan plan.

1. Expand reimbursement for special medical devices in critical and acute care through balance billing.
   Patients in urgent need of care often face the choice of incurring high out-of-pocket expenses or forgoing the use of high-value medical devices that are not yet reimbursed under the NHI system. To ensure access to optimal treatment while preserving system sustainability, the Committee urges the NHIA to consider leveraging the existing balance billing mechanism, which allows patients to pay the difference between the NHI reimbursement and the actual cost of a medical device, to provide partial reimbursement for devices supported by robust clinical evidence or endorsed by international guidelines. This approach would reduce patient financial burden and improve access to advanced medical care for critically ill individuals.
2. Broaden the application of balance billing and define a clear pathway to full reimbursement.
   Given the rapid pace of technological advancement and budgetary limitations for newly reimbursed high-value devices, the Committee recommends the expansion of balance billing to encompass innovative or functionally enhanced medical devices that have yet to meet full reimbursement criteria. Doing so would allow patients to benefit from medical innovation in a timely and affordable manner.
   Currently, the NHIA initiates the full reimbursement review process only when balance billing usage exceeds 70%. However, many devices reach this threshold after extended market use. The Committee recommends establishing a predictable review timeline and clear criteria for transitioning from balance billing to full reimbursement. Referencing domestic self-pay prices in determining reimbursement point values would facilitate more consistent decision-making and enable stakeholders to prepare for reimbursement transitions.
3. Improve pricing competitiveness to attract medical innovation.
   For product categories with limited competition, particularly those led by manufacturers from the world’s 10 most advanced pharmaceutical and healthcare markets, the Committee recommends that reimbursement pricing be benchmarked against domestic self-pay prices. If international pricing is used as a reference, adjustments should be made to reflect differences in healthcare spending as a share of GDP and population size, which heavily affect sales and production costs. A more competitive pricing structure will help maintain Taiwan’s attractiveness as an early launch market for innovative technologies and support the introduction of advanced treatments into the healthcare system.

Suggestion 5: Enhance transparency in the NHI reimbursement review process and ensure pricing rationality.

1. Improve transparency in the NHI reimbursement and pricing review processes.
   The expert-written review and consultation meetings conducted by the NHIA are essential components of the pricing and reimbursement assessment for new medical technologies. However, limited visibility into the progress and outcomes of these reviews creates asymmetries of information that hinder engagement with stakeholders and fall short of the Executive Yuan’s stated commitment to administrative transparency. To improve clarity and ensure a more participatory process, the Committee recommends the following:
   5.1.1        Ensure the timely listing of products under consideration. The Committee strongly suggests that the NHIA publish a preliminary list of high-value medical devices under consideration for NHI reimbursement in the coming year no later than in October of the preceding year. Publication should be accompanied by structured engagement with key stakeholders, including manufacturers, hospital representatives, and relevant medical associations. Implementation should proceed only after a consensus is reached, allowing adequate time for preparation to maintain stable market supply and ensure timely access for patients.

   5.1.2        Ensure timely publication of meeting records. Records from expert consultation meetings should be made available before the issuance of preliminary decisions or prior to the convening of the Pharmaceutical Benefit and Reimbursement Scheme Joint Committee (PBRS). Access to this information would allow manufacturers to assess preliminary outcomes, evaluate their readiness to participate, and provide supplementary evidence or clarifications to support the review process.

2. Refine classification and pricing for procedure-based devices and high-value reimbursement items.
   For devices integrated into medical procedures, pricing should reflect their clinical function and utility. If supported by treatment guidelines or robust evidence, these devices should either be reimbursed separately under the special materials category or reflected in an appropriate increase in the procedure’s NHI reimbursement level.
   In determining reimbursement pricing categories for high-value devices, the Committee underscores the importance of adhering to the NHI’s principles for the classification of special materials. These principles consider clinical function, product specifications, and patterns of medical use.
   The practice of relying on “me-too” declarations during TFDA registration, which serve a different regulatory purpose focused on product safety and efficacy, should not be the basis for reimbursement classification. These declarations indicate that a product is similar to an already approved item, but they are intended for regulatory approval, not for determining how much the NHIA will pay for the product.
   The NHIA should maintain its established approach of using clinically relevant distinctions in device function and application to determine appropriate reimbursement levels, preserving alignment with clinical realities and ensuring a fair and rational pricing environment that encourages the adoption of meaningful medical innovations.