Japan · Pharmaceuticals and Medical Devices Agency · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
4 requirements
Application fee
-
General medical devices (Class I) and IVDs that do not need approval or certification are notified before marketing. There is no review. The maker must hold a marketing license and notify changes within 30 days. Class I general medical devices, and IVDs outside the approval and certification routes.
1. File the notification before marketing; 2. Marketing.
Outcome: The product can be marketed after the notification is filed.
Legal basis: Pharmaceuticals and Medical Devices Act, Articles 23-2-12 and 23-2-13
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, 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, 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, Approval of an in vitro diagnostic, Two-step approval for software as a medical device. 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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.