To market an in vitro diagnostic product (IVD) in Japan, manufacturers first need to identify the applicable Japanese generic name, classification and standards based on the analyte, intended use and product characteristics.
The next step is to determine whether the product is subject to marketing notification, third-party certification or marketing approval.
An IVD that is already marketed outside Japan cannot automatically be sold in Japan. Performance evaluation, QMS, Japanese labeling and package inserts, and the Japanese marketing authorization structure must also be prepared in accordance with the Pharmaceuticals and Medical Devices Act.
In Japan, in vitro diagnostic products are regulated as a separate product category known as in vitro diagnostic pharmaceuticals.
They include reagents and kits used to examine specimens such as blood, serum, plasma or urine in order to detect or measure specific substances or parameters for diagnostic purposes.
Although IVD products are regulated separately from medical devices, their manufacturing and quality management are subject to Japan's QMS requirements.
Japanese IVD products are assigned generic names according to their intended use and analyte.
Each generic name is associated with a classification code and regulatory class.
Before determining the regulatory pathway, manufacturers should clarify:
The product name or measurement principle alone is not sufficient to determine the applicable Japanese regulatory category.
If no existing Japanese generic name appropriately covers the product, a new generic name may need to be established as part of the approval process.
Japanese IVD products are classified from Class I to Class III according to the potential risk associated with incorrect diagnostic information and its effect on clinical decisions.
In general, products whose incorrect results could have a greater impact on diagnosis or treatment are assigned a higher class.
However, classification alone does not determine whether a product can follow notification, certification or approval.
For Class I and Class II products, manufacturers must also confirm whether an applicable exemption or certification standard exists and whether the product falls within its scope.
Marketing notification when the applicable criteria are met
Certification by a Registered Certification Body when the certification standard applies
Marketing approval in principle
Approval may be required even for Class I or II
The practical sequence is therefore:
Generic name → Classification → Applicable standard → Conformity with the standard
Certain Class I IVD products that meet the applicable criteria can be marketed through a marketing notification.
Even for a notification product, the generic name, intended use, structure and principle, reagents involved in the reaction system, specifications and instructions for use must be appropriately defined.
A Class II IVD may be eligible for certification by a Registered Certification Body when a certification standard has been established and the product falls within its scope.
A product is not eligible for certification simply because it is Class II.
The analyte, intended use, performance and other characteristics must remain within the applicable certification standard.
Class III products, products involving new analytes, products for which no applicable standard exists, and products outside the scope of an existing standard may require marketing approval with PMDA review.
The application must provide scientifically reliable evidence supporting the quality, performance, effectiveness and safety of the product.
For an IVD application, it is not enough to demonstrate that the reagent produces a measurement.
The manufacturer must demonstrate that the product provides appropriate performance for its intended diagnostic use.
Depending on the product and application category, the dossier may need to address:
The required studies depend on the analyte, intended use, application category and differences from existing products.
For a new analyte or a product with a new clinical significance, correlation with an existing IVD alone may not be sufficient. Required clinical performance evidence should therefore be considered early in development.
On March 31, 2026, Japan's Ministry of Health, Labour and Welfare revised the notification governing marketing approval applications for IVD products.
The revised requirements apply to approval applications submitted on or after May 1, 2026.
The revised framework addresses supporting documentation including:
Manufacturers preparing a new Japanese IVD approval application should therefore confirm the latest requirements rather than relying only on the structure of older Japanese submissions.
IVD products are subject to Japan's QMS requirements.
A compliant QMS requires not only documented procedures and responsibilities but also evidence that the system is implemented and records are maintained.
For approval or certification, the marketing authorization holder, manufacturing sites and applicable product groups should be identified and a QMS conformity inspection may be required.
Overseas manufacturing sites may also be included in the scope of the inspection.
For foreign manufacturers, comparing the existing ISO 13485 quality system with Japanese QMS requirements before submission can help avoid delays during the regulatory process.
IVDs are regulated in Japan as in vitro diagnostic pharmaceuticals, separately from medical devices. Labeling review therefore needs to follow the IVD product category and diagnostic intended use, including the analyte, specimen types, measurement principle and performance information relevant to the Japanese submission.
IVD products marketed in Japan require labeling and package inserts that are consistent with the approved, certified or notified product information.
The package insert may include information such as:
Japanese labeling should not be prepared simply by translating an overseas IFU.
The content should be aligned with the Japanese regulatory submission and the product authorized for the Japanese market.
Foreign manufacturers planning to market an IVD in Japan should consider both the product application and the Japanese marketing authorization structure.
In Japan, the marketing authorization license required for in vitro diagnostic pharmaceuticals is separate from the Type 1, Type 2 and Type 3 marketing authorization licenses used for medical devices. A Japanese company that markets an IVD must hold an In Vitro Diagnostic Pharmaceutical Marketing Authorization Holder license.
When a foreign manufacturer applies through a Japanese Marketing Authorization Holder (MAH), that Japanese entity must hold the appropriate IVD marketing authorization license. If the foreign manufacturer uses Japan's foreign special approval route, it must appoint a Japanese Designated Marketing Authorization Holder (DMAH). The DMAH must also hold the marketing authorization license required to handle in vitro diagnostic pharmaceuticals.
Key items include:
Existing FDA, EU IVDR or other overseas documentation may be usable as supporting information, but it must be assessed against the Japanese intended use, classification, application category and documentation requirements.
The regulatory pathway should be clarified before unnecessary testing is started.
A practical sequence is:
Generic name → Classification → Applicable standard → Regulatory pathway → Required evidence
Once these points are established, the manufacturer can plan performance testing, QMS, Japanese labeling and preparation of the application dossier more efficiently.
MK Consulting K.K. supports IVD manufacturers by reviewing product information and overseas regulatory documentation and organizing the expected Japanese generic name, classification, regulatory pathway and required documentation for Japan market entry.
Not automatically.
The Japanese generic name, analyte, intended use, classification and applicable standards must be reviewed under Japanese requirements.
No.
An applicable certification standard must exist, and the product must fall within the scope of that standard. Otherwise, marketing approval may be required.
Not necessarily.
The product must meet the applicable criteria for exemption from approval. A Class I product outside those criteria may require approval.
Potentially.
The data must be relevant to the Japanese intended use, specimens, performance specifications and application category. Additional studies may be required depending on the product.
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