Japan · Pharmaceuticals and Medical Devices Agency · Medical devices
Review target
304 days
performance goal
Legal time limit
-
Not published
Steps
4
5 requirements
Application fee
¥9,381,400
Rates in the fee order version in force from 2026-05-01
A device that is neither new nor equivalent to an approved device needs approval after PMDA review. Review targets differ for files with and without clinical data. Devices with changes to approved device designs that are not clearly new and not the same as an approved device.
The official review target is 304 days (performance goal, met in 60% of cases). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The pmda review fee, improved device with clinical data, class iv is ¥9,381,400 for Rates in the fee order version in force from 2026-05-01.
1. File the application through PMDA; 2. Review (304 days); 3. QMS inspection; 4. Approval by the health minister.
Outcome: Product approval from the health minister.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 23-2-5
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 304 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal, met in 60% of cases. About 10 months for improved devices with clinical data approved in FY2026, and about 6 months without clinical data. This is an official performance target, not an actual review time. It counts total time from filing to approval, including the applicant's time. | 304 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| PMDA review fee, improved device with clinical data, Class IVApplication · Rates in the fee order version in force from 2026-05-01 · Small and venture companies that meet set conditions can get half of PMDA consultation and application fees back for qualifying innovative devices, regenerative products and IVDs, under a government-funded program. | ¥9,381,400 |
| PMDA review fee, improved device with clinical data, Class II or IIIApplication · Rates in the fee order version in force from 2026-05-01 · Small and venture companies that meet set conditions can get half of PMDA consultation and application fees back for qualifying innovative devices, regenerative products and IVDs, under a government-funded program. |
Other routes in Japan: Approval held by a foreign manufacturer through a designated marketing authorization holder, Priority review, Fast priority review of a product already sold abroad during a supply shortage, Conditional approval, Pioneering product designation (SAKIGAKE), Orphan designation, Specific-use product designation, Notification of a Class I device or a low-risk IVD, Third-party certification by a registered certification body, Approval of a new medical device, Approval of a generic (equivalent) medical device, Two-step approval for software as a medical device, Combination products (drug, device or regenerative product). See all routes on the or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (21 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
| ¥5,618,800 |
| PMDA review fee, improved device without clinical data and without approval standard, Class IVApplication · Rates in the fee order version in force from 2026-05-01 · Small and venture companies that meet set conditions can get half of PMDA consultation and application fees back for qualifying innovative devices, regenerative products and IVDs, under a government-funded program. | ¥2,991,200 |