Japan · Pharmaceuticals and Medical Devices Agency · Medical devices
Review target
426 days
performance goal
Legal time limit
-
Not published
Steps
6
5 requirements
Application fee
¥16,431,300
Rates in the fee order version in force from 2026-05-01
A device that clearly differs from approved devices in structure, use, effect or performance needs approval from the health minister after PMDA review. The council is consulted. New devices can be designated for use-results evaluation after approval. Devices that are new in structure, use, effect or performance compared with approved devices.
The official review target is 426 days (performance goal, met in 80% of cases). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The pmda review fee, new medical device, class iv is ¥16,431,300 for Rates in the fee order version in force from 2026-05-01.
1. File the application through PMDA; 2. Review (426 days); 3. QMS inspection; 4. Pharmaceutical Affairs Council opinion; 5. Approval by the health minister; 6. Use-results evaluation.
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 426 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 80% of cases. About 14 months for standard new devices approved in FY2026. For priority new devices the target is about 10 months. This is an official performance target, not an actual review time. It counts total time from filing to approval, including the applicant's time. | 426 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| PMDA review fee, new medical device, 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. | ¥16,431,300 |
| PMDA review fee, new medical device, 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 an improved 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 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
| ¥11,727,000 |