Medical Device Approval Process in Japan

Written and edited by MK Consulting K.K.

This guide follows the decisions and documents passed from one approval stage to the next: establishing the pathway, planning evaluations, preparing the dossier and responding to review questions. The aim is to keep the rationale traceable throughout the process.

For how Japan distinguishes new, improved, and generic medical devices in approval applications, see New, Improved, and Generic Medical Devices in Japan.

During the approval review, consistency across the entire dossier is important, including the application form, STED, performance and safety data, risk management, clinical evaluation, QMS, labeling, and package insert.

Confirm the Regulatory Pathway Before Starting an Approval Application

The main regulatory pathways for medical devices in Japan are:

Marketing notification
Certification by a Registered Certification Body
Marketing approval

Whether approval is required is not determined by classification alone.

The generic name, JMDN code, classification, availability and scope of certification standards, intended use, structure and principle of operation, and differences from approved devices must be reviewed.

Even if a device is approved and marketed overseas, the same regulatory pathway may not apply in Japan.

If testing begins before the regulatory pathway and comparator are clear, issues may later arise regarding the representativeness of test samples or missing evaluation endpoints, resulting in rework.

Confirm the applicant and Japan-side MAH/DMAH arrangement for the proposed application. See DMAH requirements in Japan when considering a designated MAH structure.

New, Improved, and Generic Medical Devices

For an approval application, the application category—new, improved, or generic—is considered separately from device classification by comparing the device with previously approved products. The category affects how the comparison is made and how the required evidence is planned. For the detailed decision points, see “New, Improved, and Generic Medical Devices in Japan.”

For registration planning across approval, certification and notification, see medical device registration in Japan.

From Classification Confirmation to Post-Approval Launch Preparation

01
Establish the Classification Rationale
Compare the intended use, design and operating principle, site of use and contact duration with the generic device definition. Record the proposed generic device name, JMDN code and classification, together with the rationale.
02
Decide Whether Approval Is Required
Compare the device with the relevant certification standard to determine whether marketing approval is required. Identify any unresolved questions about eligibility for certification before finalizing the pathway.
03
Define the Application Category and Consultation Questions
Use the comparison with approved devices to explain the proposed new, improved or generic application category. For unresolved issues, set out the company's position and supporting evidence alongside the questions for a PMDA consultation.
04
Link Evaluation Questions to Supporting Evidence
For each difference from approved devices, identify the performance, safety or clinical question and the evidence intended to address it. Separate what existing data support from what needs further evaluation, and reflect this in the evaluation plan.
05
Assemble a Consistent Application Dossier
Link the application form and STED explanations to the test reports, Essential Principles documentation, risk management and clinical evaluation. Align the intended use, specifications, results and conclusions across the dossier.
06
Submit the Application and Track QMS Preparation
Submit the dossier. For the parallel QMS conformity assessment, track the quality documents and submission status for the relevant manufacturing sites and product group, keeping the product and manufacturing information consistent with the approval dossier.
07
Respond to Each PMDA Inquiry with Traceable Evidence
Identify the issue behind each question and ensure consistency among the response, supporting evidence, and any revisions to the application dossier.
08
Identify the Remaining Work Before Launch
Review the readiness of labeling and package inserts, manufacturing and release, and post-market safety management, and identify the work still needed for launch after approval. Where reimbursement is relevant, consider its evaluation approach and documentation alongside the regulatory application.

Main Documents Prepared for an Approval Application

Application Form

Describe the product name, intended use, shape and structure, principle of operation, product specifications, operating method, manufacturing method, and other required information.

STED

Organize the product overview, development history, comparison with approved devices, Essential Principles, performance and safety, clinical evaluation, and related information.

Performance and Safety Data

Depending on the characteristics of the device, prepare data on performance testing, biological safety, electrical safety, sterilization, packaging, stability, software, and other relevant areas.

Risk Management

Link hazards, risk control measures, and residual risks with design, testing, labeling, and other controls.

Clinical Evaluation

Explain safety and effectiveness using comparisons with approved devices, literature, overseas clinical data, clinical study results, and other evidence.

Labeling and Package Insert

Ensure that the intended use, warnings, contraindications, precautions, operating method, and other information are consistent with the application content.

Main Issues That May Require Explanation During PMDA Review

Intended use	Align the target patient population, site of use, and clinical purpose with the test and clinical data.
Differences from approved devices	Explain differences in structure, principle of operation, materials, performance, and method of use, and the impact of those differences on safety and effectiveness.
Validity of testing	Explain why the test method, test samples, worst-case conditions, and acceptance criteria are appropriate for evaluating the product under application.
Clinical rationale	Clarify which issues can be addressed by nonclinical testing and which require explanation with clinical data.
Consistency across documents	Keep terminology, specifications, and conclusions consistent across the application form, STED, test reports, risk management, clinical evaluation, labeling, and package insert.

Medical Device Approval Review

PMDA's medical device page links to its review, consultation and QMS conformity assessment guidance. Use the relevant section for the procedures and documents needed at each stage.

PMDA medical device review, consultation and QMS guidance (Japanese)

Common Causes of Rework During Approval Review

Preparing for an approval application without first confirming whether the device falls within a certification standard
Starting testing before the application category and comparator are finalized
Being unable to explain differences between the test sample and the product under application in model, materials, or manufacturing process
Misalignment between the intended use and performance testing or clinical evaluation
Inconsistent descriptions across the application form, STED, test reports, labeling, and package insert
Managing the approval review and QMS conformity assessment separately, causing delays in document preparation
Adding a new explanation in an inquiry response that creates inconsistencies with other application materials

For hands-on support with approval, certification, notification, application dossiers, and inquiry responses, see Approval, Certification & Notification Support.

Frequently Asked Questions

Can a Class II medical device still require a marketing approval application?

Yes. A Class II medical device may require marketing approval, for example when it does not fall within the scope of an applicable certification standard.

Can we submit an approval application without a PMDA consultation?

A PMDA consultation is not mandatory for every product.

If there is uncertainty regarding the application category, comparator, clinical evaluation, or testing strategy, consider consulting PMDA before finalizing the strategy for major tests and application materials.

Is QMS conformity assessment conducted after approval?

In general, it is handled in parallel with the approval review.

The relevant manufacturing sites, product group, and any existing certificates of conformity should be confirmed at an early stage.

Can overseas test data be used in a Japanese approval application?

In some cases, yes.

The applicable test standards, relationship between the test samples and the product to be submitted in Japan, acceptance criteria, and applicability to the Japanese use environment should be confirmed.

You Can Consult Us from the Early Stage of Considering an Approval Application

We review the product information and approved devices and help organize the regulatory pathway, application category, required testing, clinical evaluation, application dossier, and whether a PMDA consultation should be considered.