Japan · Ministry of Health, Labour and Welfare · Medical devices
Review target
-
Not published
Legal time limit
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Not published
Steps
4
5 requirements
Application fee
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Class II and some Class III devices, and some IVDs, that meet a standard set by the health minister are certified by a registered certification body instead of being approved by the minister. The body checks conformity with the standard and the quality system. Products that do not fit a standard go to approval. Controlled or highly controlled devices and IVDs for which the minister has set a certification standard.
1. Apply to a registered certification body; 2. Conformity review; 3. QMS inspection by the certification body; 4. Certification.
Outcome: Certification for each product by the registered certification body.
Legal basis: Pharmaceuticals and Medical Devices Act, Articles 23-2-23 and 23-3
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, Notification of a Class I device or a low-risk IVD, 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.