Medical device reimbursement in Japan, Korea, Taiwan and Australia runs on four different systems, and a figure that looks like a price means something different in each. If you're a startup planning Asia-Pacific entry, registration is the step you budget for. What comes after it decides whether anyone gets paid to use your device.
We read each market's fee schedules and device lists at the official issued copies, as of November 9, 2026. Each market below answers the same questions in the same order. Then come six ways a reimbursement figure gets misread, which is where a plan built on "they pay 100" meets a hospital that's paid 300, or 30.
Key takeaways
- Registration isn't payment. In all four markets a separate list decides how a device is paid, and many devices are paid only inside a procedure fee.
- None of these figures is paid to the manufacturer. Japan's reimbursement price, Korea's ceiling, Taiwan's points and Australia's minimum benefit pay for a hospital's use of a device. Your own price is negotiated separately.
- Points aren't money. Japan fixes 1 point at ¥10, Korea's won per point depends on the institution, and Taiwan's point value floats.
- Korea is the exception on AI. A technology listed as an innovative medical technology can carry its own fee, paid by the patient up to a ceiling: ₩18,100 per use for the MRI and CT analysis listed so far.
- Taiwan lists AI at zero; Australia's device list excludes it. Taiwan's two AI items carry 0 points, and the Prescribed List excludes devices used solely for diagnosis.
- Check the edition date. Japan revised its prices on June 1, 2026, and Australia's list changes three times a year.
How do the four markets compare?
| Japan | South Korea | Taiwan | Australia | |
|---|---|---|---|---|
| Own listing after registration? | Depends on the category: A1 and A2 devices are paid inside a procedure fee; B devices get their own price | Devices billed on their own are on the treatment-materials list, each with a ceiling and a status | Devices billed separately are listed as special materials, each code against a TFDA license | Prescribed List for devices used in private hospital admissions; the procedure is paid through Medicare (MBS) |
| Who sets it | MHLW (Ministry of Health, Labour and Welfare) | MOHW by notice; HIRA publishes the lists | NHIA (National Health Insurance Administration) | The Minister, in the Prescribed List Rules |
| What the figure is | A fixed national fee in points, or a fixed reimbursement price in yen | Device: a ceiling. Procedure: points × a won value per point | Points; the point value floats | A minimum benefit: a floor |
| Who is paid | The hospital or clinic | The hospital or clinic | The hospital | Paid by the patient's private insurer for the admission, never to the sponsor |
| AI software paid separately? | MR workstation programs are on the bundled list | Yes, if listed as an innovative technology: a ceiling the patient pays | No: two AI items at 0 points | No Prescribed List route; no MBS imaging item names AI |
How does Japan pay for a medical device after approval?
- Separate decision? It depends on the category. A1 devices are covered inside the procedure fee, with no separate payment. For A2 devices, the device type is a condition for billing a particular fee item, and the device earns nothing itself. B devices are specified insurance materials (特定保険医療材料) with their own reimbursement price, billed on top of the procedure fee. A new technique (C2) needs its own decision.
- Who decides. MHLW (the Ministry of Health, Labour and Welfare) sets the fee schedule and the material prices. For A1 and A2, the deciding fact is the generic name PMDA gives your device, because MHLW's bundled lists are written by generic name.
- Who's on the listing. A B device's functional category, and so its price, is decided on application. One generic name can sit in several categories at very different prices, so a competitor's price is a reference, not a promise.
- What the figure is, and who's paid. Everything goes to the hospital or clinic. A fee item is fixed in points, at 1 point = ¥10. A reimbursement price (償還価格) is what insurance pays the hospital for the material; the hospital buys below it, and the manufacturer's own price is lower still and not published. Insurance pays 70–90% of each amount and the patient 10–30%, up to a monthly high-cost cap.
- What changes the real amount. MRI is paid by scanner tier: 1,700 points at 3 T or more, 1,330 at 1.5 to 3 T. The top tiers and most add-ons need a facility standard notified to MHLW. Material prices are revised every two years, last on June 1, 2026, and are usually cut.
- Software and AI. MR workstation programs are on the bundled list, and the MRI fee is paid whatever image processing is used. A few analyses have their own fee item, such as CT-based fractional flow reserve analysis (E200-2). Whether a bundled device still needs a coverage filing is a question to settle with a Japan specialist.
- First step for a startup. Confirm the generic name you'll be filed under before you model revenue: it decides whether you sit inside someone else's fee or have a price of your own.
How one fee becomes a bill. On the 2026 schedule, a 3 T brain MRI at a hospital holding the top imaging-management add-on adds up to: scan 1,700 + head MRI add-on 100 + reading fee 450 (once a month) + electronic image management 120 + imaging management add-on 340 = 2,710 points (¥27,100). The scan fee alone is ¥17,000. The lowest management add-on is 70 points, so a given hospital's bill depends on the add-ons it qualifies for.
How does South Korea pay for a medical device after licensing?
- Separate decision? Devices billed on their own sit on the treatment-materials list (치료재료 급여·비급여 목록 및 급여상한금액표), each code with a ceiling and a status: covered, selective pay (partly covered, with a set patient share) or non-covered. The current notice, No. 2026-203, took effect on October 1, 2026, and the list is amended many times a year.
- Who decides. The Ministry of Health and Welfare (MOHW) sets the lists by notice (고시). HIRA, the Health Insurance Review and Assessment Service, publishes them.
- Who's on the listing. Each code names its maker and, for an imported device, its importer. MFDS publishes a link from a device's UDI and license to its insurance claim code.
- What the figure is, and who's paid. A device ceiling (상한금액) is the most insurance recognizes for the code. The hospital is reimbursed up to it, and for imports it moves with the exchange rate. Procedures are paid in points times a won value per point, set each year by type of institution: in 2026, ₩83.8 at hospitals and ₩95.6 at clinics. That gives a schedule amount, insurer and patient together, paid to the institution.
- What changes the real amount. The institution type, the coverage criteria, selective pay and the patient's share. An MRI's scan and its reading are separate codes.
- Software and AI. Korea pays AI separately, but only for technologies listed in Part 5 of the procedure schedule, the innovative medical technology list. A non-covered listing carries a ceiling the patient pays in full, and the hospital may charge less: ₩18,100 per use for the MRI and CT analysis listed so far. Hospitals' disclosed charges sit at or below it. The annex names each product; unlisted AI is paid inside the scan.
- First step for a startup. Make sure your MFDS license maps to an insurance claim code. If you make software, decide early whether to seek innovative-technology listing, and remember that an application, which NECA publishes, isn't a listing.
How does Taiwan's National Health Insurance pay for a device?
- Separate decision? Devices billed separately are NHIA special materials (特殊材料). Each code carries its points, the date they apply from, whether prior review (事前審查) is required, and the TFDA license number it's listed under. A license with no code doesn't mean "not paid": many devices are paid inside a procedure's fee.
- Who decides. NHIA, the National Health Insurance Administration, under the National Health Insurance Act. The list's legal copy is Annex 3 of regulation L0060035, last amended on August 24, 2026.
- Who's on the listing. Each code names the firm and the license it's listed against. That makes license ownership a reimbursement question too: settle who holds your Taiwan license before you sign a distributor.
- What the figure is, and who's paid. Points, not dollars, paid to the hospital, which pays its doctors. A device's points are NHI's payment for it, billed by the hospital on top of the procedure; the maker sells to the hospital at a negotiated price. A brain MRI is 6,500 points without contrast and 11,500 with it (33084B and 33085B), paid per examination and only at facilities NHIA has approved.
- What changes the real amount. The point value floats under the global budget, and whether device points are paid at a fixed NT$1 or at the floating value isn't settled. For balance-billed devices, such as premium intraocular lenses, drug-eluting stents and special hips, the patient pays the difference above NHI's payment (Art. 45), and NHIA publishes each hospital's charge. Prior review, the co-payment (Art. 43), Tw-DRG case payments and mid-year price moves matter too.
- Software and AI. Two AI items, intracranial-bleed detection on non-contrast CT (N21902) and thyroid-nodule ultrasound analysis (N21903), are listed at 0 points as health-technology-assessment items, in force from January 1, 2025. NHI pays nothing for them, and there's no AI item for MRI.
- First step for a startup. Look up your category: is there a code, does it need prior review, and is it balance-billed?
How does Australia pay for a medical device after ARTG inclusion?
- Separate decision? Yes, for devices used in private hospital admissions: the Prescribed List, Schedule 1 of the Private Health Insurance (Medical Devices and Human Tissue Products) Rules. The procedure is paid separately through Medicare's schedule, the MBS. The current list, F2026L01393, commenced on November 1, 2026.
- Who decides. The Minister makes the Rules. MBS items sit in regulations and section 3C determinations, and a new item comes through an application to MSAC.
- Who's on the listing. Each billing code names its sponsor. The Rules set the fees: $1,520 to apply, $4,340 for clinical assessment, and $12,480 to $35,690 for economic assessment.
- What the figure is, and who's paid. A minimum benefit: the least a complying private hospital policy must pay for the device in an admission. It's a floor, not a price. The sponsor never receives it, and what a hospital pays the sponsor is negotiated. No maximum is printed. It's owed only when the patient's cover includes the treatment, and some codes carry printed conditions.
- What changes the real amount. For specified ablation and electrophysiology items used in one treatment, the Rules cap the combined minimum benefits at $6,399, shared in proportion. With amounts on today's list, a $6,399 catheter used with a $2,200 mapping catheter, a $1,550 intracardiac catheter and a $499 patch falls to about $3,846. How insurers apply the cap to newer catheter types isn't settled. The list changes on March 1, July 1 and November 1, and post-listing reviews can propose cuts. On the Medicare side, the benefit is 75% of the MBS fee in hospital and 85% out of hospital.
- Software and AI. Part A excludes a device "used solely for diagnosis, prediction, or prognosis" (s 12(3)), and Part C takes only the kinds named in s 14(2). No MBS imaging item names AI. Head MRI item 63001 (a tumor of the brain or meninges) carries a fee of $463.80 from July 1, 2026, and each head-MRI item is written for specified indications.
- First step for a startup. Work out which schedule you belong in, the Prescribed List or a procedure paid through the MBS, then check whether your indication fits an existing MBS item.
What does an AI brain-MRI tool earn in each market?
Here's a worked example. Say your AI software analyzes brain MRI scans and is registered in all four markets.
- Japan. Filed as an MR workstation program, it's on the bundled list. The hospital bills the MRI, 1,700 points for a 3 T scan, whether or not your software ran.
- Korea. Unlisted, it's paid inside the scan. Once listed as an innovative medical technology, the hospital may charge the patient up to its group's ceiling, ₩18,100 per use for MRI and CT analysis so far. Which group a new product lands in isn't settled.
- Taiwan. The hospital is paid 6,500 points for the MRI. There's no AI item for MRI.
- Australia. There's no Prescribed List route, and no MBS imaging item names AI. Medicare pays for the scan only where an MBS item fits the indication.
Here's the catch. In three of the four markets, the hospital's payment for the scan is the same whether or not it uses your software. Your price is a conversation with the hospital, and the figure on the fee schedule is what the hospital is paid, not what you are.
Why does the same reimbursement figure mean different things? The 100 vs 300 problem
A planning sheet that copies "the reimbursement" from four markets into one column is usually comparing four different things. Six ways it goes wrong:
- Points aren't money. Japan converts at a fixed ¥10, Korea's won per point differs by institution, and Taiwan's point value floats.
- One line isn't the whole bill. Japan's MRI scan fee is ¥17,000; the schedule adds up to ¥27,100 with the top add-ons. Korea bills the scan and its reading as separate codes.
- A ceiling, a floor and a fixed price look identical. Korea's device figure is a maximum, Australia's a minimum, Japan's a fixed price, and Taiwan's only part of the charge on a balance-billed device.
- The payee isn't you. The money goes to the hospital or for the admission, and your own price is negotiated separately.
- Conditions decide which figure applies. Scanner tiers and facility standards in Japan, approved facilities and prior review in Taiwan, indication-specific items in Australia, coverage criteria in Korea.
- Caps, top-ups and dates move the number. Australia's $6,399 shared cap, Taiwan's patient top-ups, Japan's two-yearly cuts and Australia's three editions a year.
See these lists in one place
Meridian Trace's Reimbursement page shows each market's official lists inside the product, market by market, and labels every figure with what it is and who is paid.
Try it free →Frequently asked questions
Does registration mean my device is reimbursed in Japan, Korea, Taiwan or Australia?
No. In all four, a separate list decides how a device is paid, and many devices are paid only inside a procedure fee.
Is AI software reimbursed separately in Asia-Pacific?
In Korea, yes, for technologies listed as innovative medical technologies: the patient pays up to a ceiling, 18,100 won per use for the MRI and CT analysis listed so far. Taiwan lists two AI items at 0 points, and Australia's Prescribed List excludes devices used solely for diagnosis.
Are Taiwan NHI points the same as Taiwan dollars?
No. National Health Insurance pays in points, and the point value floats under a global budget.
What is the minimum benefit on Australia's Prescribed List?
The least a complying private hospital policy must pay for a listed device used in an admission. It's a floor, not a price, and the sponsor never receives it.
Who receives Japan's reimbursement price for a device?
The hospital or clinic. It buys the device below that price, and the manufacturer's own selling price is lower still and not published.
The short version
After registration, Japan sorts your device into a category, Korea and Taiwan list it with a ceiling or points, and Australia lists it with a minimum benefit or pays for the procedure through Medicare. Every payment goes to the hospital or for the admission. Before you put a reimbursement figure in a plan, write down what it is, who receives it, and which edition it came from.
Sources, read between November 6 and 9, 2026. Japan: MHLW, 2026 medical fee schedule (in force June 1, 2026), items E200-2, E202, E203 and the imaging management add-ons, as published in MHLW's medical fee information service, shinryohoshu.mhlw.go.jp; MHLW notice 保医発0305第3号, 別表2 (devices bundled into procedure fees). South Korea: MOHW Notice No. 2026-203, 치료재료 급여·비급여 목록 및 급여상한금액표 (in force October 1, 2026), law.go.kr; MOHW Notice No. 2025-186, 건강보험요양급여비용의 내역 (point values for 2026), law.go.kr; MOHW, 건강보험 행위 급여·비급여 목록표 및 급여 상대가치점수 (Notice No. 2026-228, in force November 1, 2026), including Part 5, 혁신의료기술 급여·비급여 목록, and its annex as in force September 1, 2026 (Notice No. 2026-174); HIRA, 디지털의료기술 비급여 금액 공개, hira.or.kr; MFDS, 의료기기 UDI/EDI 정보 조회 서비스 (data.go.kr 15138675). Taiwan: NHIA, 健保特材收載品項, info.nhi.gov.tw; 全民健康保險藥物給付項目及支付標準 (L0060035), Annex 3, law.moj.gov.tw; NHIA, 醫療服務給付項目及支付標準, items 33084B, 33085B, N21902 and N21903, info.nhi.gov.tw; NHIA, 民眾自付差額品項收費情形, info.nhi.gov.tw; National Health Insurance Act, Articles 43, 45 and 62. Data source: 衛生福利部中央健康保險署 (National Health Insurance Administration), under the Open Government Data License. Australia: Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 4) 2026, F2026L01393, Volumes 1 and 2, legislation.gov.au; Private Health Insurance Act 2007, section 333-20; Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020, compilation F2026C01146; MBS item 63001, MBS Online. Australian instruments: based on content from the Federal Register of Legislation, November 2026, under CC BY 4.0. This is a summary for planning, not legal, regulatory or reimbursement advice; check the current instrument before acting.