Japan · Pharmaceuticals and Medical Devices Agency · Medical devices
Review target
122 days
performance goal
Legal time limit
-
Not published
Steps
4
5 requirements
Application fee
¥2,244,900
Rates in the fee order version in force from 2026-05-01
A device that is the same as an approved device in structure, use, effect and performance, but is not covered by a certification standard, needs approval after PMDA review. Fees are lower when an approval standard exists. Devices equivalent to approved devices that do not fall under third-party certification.
The official review target is 122 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, generic device without clinical data and without approval standard, class iv is ¥2,244,900 for Rates in the fee order version in force from 2026-05-01.
1. File the application through PMDA; 2. Review (122 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 122 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 4 months for generic devices approved in FY2026. This is an official performance target, not an actual review time. It counts total time from filing to approval, including the applicant's time. | 122 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| PMDA review fee, generic 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. | ¥2,244,900 |
| PMDA review fee, improved or generic device without clinical data and without approval standard, 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. | ¥1,790,500 |
| PMDA review fee, generic device with an approval standard, 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. | ¥437,000 |
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 an improved medical device, Two-step approval for software as a medical device, Combination products (drug, device or regenerative product). See all routes on the Japan page or explore them in the Regulatory section.
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.