Japan · Pharmaceuticals and Medical Devices Agency · Diagnostics (IVD)
Review target
213 days
performance goal
Legal time limit
-
Not published
Steps
4
5 requirements
Application fee
-
IVDs are drugs used only for diagnosis that are not used directly on the body. In Japan they follow the device chapter of the law. IVDs that are not covered by notification or certification need approval from the health minister after PMDA review. IVDs not set as notification products and not covered by a certification standard, including companion diagnostics.
The official review target is 213 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.
1. File the application through PMDA; 2. Review (213 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 2(14) and 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 213 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 7 months for standard IVDs approved in FY2026, and about 12 months for IVDs that need expert consultation. This is an official performance target, not an actual review time. It counts total time from filing to approval, including the applicant's time. | 213 days |
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, Third-party certification by a registered certification body. 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.