As medical technology continues to advance rapidly, the proliferation of self-funded medical devices has become increasingly common. According to medical regulations, the standards for medical service charges are approved by the health bureaus of various counties and cities. However, with the advent of digital medical devices and cell therapy, the National Health Insurance Administration (NHIA) is developing a "Self-Funded Medical Device Approval and Pricing Platform." This initiative will feature a single-window submission process, standardized application documentation, and a joint review mechanism with 22 county and city health bureaus, aiming to expedite the approval and pricing of self-funded medical devices. A trial implementation of this platform is expected to commence by the end of the year.
NHIA Director-General Shi Chongliang, speaking at the "Taiwan Digital Therapy Industry Development Trends Forum," addressed the issue: "Many might think that the approval of self-funded medical devices is a matter for local health bureaus, not the NHIA." However, he pointed out that in the absence of a regulatory body, the NHIA must step in. Currently, many self-funded medical device companies seek guidance from the NHIA on pricing their devices, and then submit applications to one or multiple county or city health bureaus. The different review procedures and pricing methods across these bureaus, especially with advancements in medical technology such as CAR-T cell therapy and digital medical devices, often result in prolonged review times.
To resolve the lengthy approval times for self-funded medical devices, Shi stated that the NHIA is working on the "Self-Funded Medical Device Approval and Pricing Platform." This platform will feature a single-window submission process and standardized application documentation. It will also establish a joint review mechanism with health bureaus' medical review committees across all counties and cities. Unlike the previous system where medical institutions had to initiate the approval and pricing process, the new system will allow medical device manufacturers to apply directly, speeding up the application and review process. This eliminates the need for companies to submit proposals individually to 22 different county and city health bureaus, as coordination is ongoing.
Shi explained that under the new system, when a medical device company applies for approval, they must provide evaluation reports from two medical institutions. These institutions must be regional hospitals or teaching hospitals. If the evaluation determines that the medical device falls under the NHIA's bundled payment items, it cannot be classified as a self-funded item. Otherwise, it will be categorized as a self-funded medical device. The application will then be submitted to the health bureau of the county where the evaluating medical institution is located for review. Post-review, the information will be made publicly available on a shared information platform for reference by other counties and the public, thus accelerating the market entry of self-funded medical devices.
Shi also noted that while the approval and pricing of self-funded medical devices will be unified, final pricing authority currently resides with the individual county health bureaus. Therefore, final prices may vary between counties. For instance, some counties might find Taipei’s pricing too high and prefer lower prices. Even in such cases, companies will not need to reapply; county health bureaus can directly reference the approved data for quick pricing adjustments.
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