Japan Medical Device Reimbursement (C1/C2 listings, in English)

Latest Chuikyo device listings (last 2)

Each line is one reimbursement price or fee decided at a Chuikyo general meeting (a product with two sizes or parts can have two lines). “Peak forecast” = peak-year sales and patients as printed in the paper (Y10 = tenth year after listing). “vs foreign avg.” = price ÷ foreign average price. “PMDA approval” links to the Japan new medical device approvals list when the brand matches.

Click a column header to sort. JP = no English name found; Japanese kept. Source: MHLW / Chuikyo (PDL1.0). Unofficial English translation, edited by Japan Pharma Regulatory Brief.

Earlier decisions (counts)

Earlier Chuikyo decisions are shown as counts only. The full archive — every product, price, premium, foreign price ratio and peak forecast, with CSV — is in the subscriber edition.

Download: counts per Chuikyo decision (CSV, aggregated).

How Japan medical device reimbursement works

PMDA approval (or certification) lets a company sell a device in Japan. It does not decide whether hospitals are paid for using it. For that, the marketing authorisation holder files a separate insurance application (保険適用希望書) with MHLW, which assigns a reimbursement category. Most devices are simply covered inside existing procedure fees. Devices that are paid separately are special treatment materials (STM, 特定保険医療材料): catheters, stents, implants, electrodes, wound dressings and the like, reimbursed at a price set for each functional category (機能区分), not for each brand. Genuinely new products need a new category or a new procedure fee, decided by Chuikyo, the Central Social Insurance Medical Council. Those decisions are what this page tracks.

Reimbursement categories (FY2026 rules, in force from 1 June 2026)

Sources: MHLW notice on insurance coverage of medical devices (産情発0213第4号・保発0213第6号, 13 Feb 2026) and MHLW notice on insurance coverage of in-vitro diagnostics (産情発0213第5号・保発0213第8号, 13 Feb 2026). Short English descriptions are ours.

Timelines: C1 about 4 months, C2 about 5 months, then a quarterly listing

• Standard processing period. For applications filed by the end of a month, the clock starts on the 1st of the next month. MHLW decides the category within 4 months for C1, B3 and R (when at least 80 days of review time are available) and within 5 months for C2 (at least 100 days). Time for corrections, additional data and holidays is not counted, and a company objection restarts part of the process.
• Listing dates. C1, C2, B3 and R products are listed four times a year, in March, June, September and December, if the category was decided by the end of the month before. Chuikyo's general meeting approves each batch, usually 1–3 months ahead (for example, the 1 December 2026 batch was approved on 16 September 2026).
• Exception. A C2 device used to decide whether a patient should receive a drug (a companion diagnostic) can be covered from the 1st of the month after the decision, to line up with the drug.
• By contrast, A1 devices are covered 20 working days after the application, and A2/B1 devices from the 1st of the next month if the application arrives by the 10th.

Source: MHLW notice, sections 2 and 4; quarterly months and cut-off also in MHLW filing procedure notice (医政産情企発0213第2号・保医発0213第10号). Third-party guides that give January/April/July/October or “6–18 months” do not match the current notice.

How a new STM price is set

• Similar-function comparison (類似機能区分比較方式): the new category takes the price of the most similar existing functional category (or a sum, difference or pro-rata share of existing categories), then premiums are added.
• Cost accounting (原価計算方式): used when there is no similar category. Price = manufacturing or import cost + selling and general expenses + operating profit + distribution cost + consumption tax. Premiums are multiplied by a coefficient that depends on how much of the cost the company discloses: 1.0 (80% or more disclosed), 0.6 (50–80%), 0.2 (under 50%).
• Premiums (補正加算), base rate A: innovativeness (画期性) 50–100%; usefulness (有用性) 5–30%; improvement (改良) 1–20% (1–10% for the time-limited premium); marketability I (市場性I, orphan devices) 10%; marketability II (市場性II, small patient population) 1–5%; pioneering / SAKIGAKE (先駆) 10%; specified use (特定用途) 10%. The applied rate is scaled by price level (between 0.5A and 1.5A). A separate economy premium (経済性加算) rewards devices that cut material costs.
• Foreign average price adjustment (外国平均価格に基づく価格調整): the foreign average price is the simple average of the prices of the most similar device in the US, UK, Germany, France and Australia. If the calculated price (with premiums) is above 1.25× that average, it is cut to 1.25×. The cap is 1.5× for orphan, pioneering or specified-use devices, devices developed at MHLW's request, and new categories that received an innovativeness or usefulness premium of 10% or more. If the highest country price is more than 2.5× the lowest, the highest is left out. The “vs foreign avg.” column below is that ratio as printed by Chuikyo.
• At each biennial revision, existing categories priced at 1.3× or more of the foreign average are repriced.
• Chuikyo papers also state whether a product falls under cost-effectiveness evaluation; products with a forecast peak market under ¥5 billion are marked “not applicable”.

Source: MHLW standards for calculating STM reimbursement prices (保発0213第5号, 13 Feb 2026), chapter 1 and tables 1-1, 2 and 4; cost-effectiveness line from the Chuikyo listing papers. Rules as of FY2026; they are revised every two years.

From approval to reimbursement

New device approvals come first: Japan new medical device approvals (PMDA list in English). Review fees and times: PMDA consultation fees & timelines. Drugs: Japan new drug approvals. For drugs, the subscriber edition also has the quarterly NHI new-drug price listing digest (price, comparator, premiums, peak sales).