Japan · Pharmaceuticals and Medical Devices Agency · Software as a medical device
Review target
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Not published
Legal time limit
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Not published
Steps
3
2 requirements
Application fee
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Software that is a medical device is regulated as a device and needs approval, certification or notification by risk. Under ministry guidance, software can first be approved for a limited purpose that current data can show. After clinical evidence builds up in use, the holder applies for a partial change approval to expand the claims. Software as a medical device whose clinical significance is not yet established but whose function or performance can be shown for a narrower purpose.
1. First approval with limited claims; 2. Use in clinical practice; 3. Partial change application.
Outcome: A first approval with limited claims, followed by a partial change approval when evidence is available.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 2(13) and Article 23-2-5; MHLW notice on two-step approval of 16 November 2023 and guidance of 2024
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Japan: Approval held by a foreign manufacturer through a designated marketing authorization holder, Priority review, Conditional approval, Pioneering product designation (SAKIGAKE), 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, Approval of a generic (equivalent) medical device. 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.