TIMELINE / COST

Japan Medical Device Approval Timeline and Costs

Written and edited by MK Consulting K.K.

The time needed to obtain medical device marketing approval in Japan depends on the application category and the readiness of the supporting evidence. PMDA conducts the approval review; the Minister of Health, Labour and Welfare grants approval. Published total review-time targets cover submission to approval, not pre-submission testing and dossier preparation or post-approval launch work. Estimate official review, consultation, and QMS assessment fees separately from testing, clinical evaluation, translation, document preparation, and inquiry-response costs.

ESTIMATING

Estimate the Time and Cost Required from Application Preparation Through Commercial Launch

In addition to PMDA's total review time, allow time for confirming the application strategy, testing and document preparation, PMDA consultation, QMS conformity assessment, and post-approval labeling and release preparation.

In addition to official fees, the budget should include additional testing, clinical evaluation, translation, application dossier preparation, inquiry responses, and QMS preparation.

For the distinction between review and approval, see the section on marketing procedures and device classification in PMDA’s medical device overview (Japanese).

PMDA Total Review-Time Targets in the FY2026 Annual Plan

New medical device (standard review)
14 months (80th percentile)
New medical device (priority review)
10 months (target to be achieved)
Improved medical device (with clinical data)
10 months (60th percentile)
Improved medical device (without clinical data)
6 months (60th percentile)
Generic medical device
4 months (60th percentile)

Source: PMDA FY2026 Annual Plan, section 3(2), medical device review, items A–B, printed pages 12–13 (Japanese). Total review time runs from submission to approval; these targets do not guarantee an individual approval date. The 80th and 60th percentiles indicate the time within which 80% and 60% of the included applications fall. Standard new, improved with clinical data, improved without clinical data, and generic devices exclude cases with applicant document-preparation periods of at least 14, 10, 6, and 4 months, respectively. The plan does not specify a percentile for the priority-review target.

For launch planning, distinguish pre-submission testing and dossier preparation, consultation, review and inquiry responses, QMS assessment, and post-approval preparation. Some work runs in parallel, so do not simply add every activity’s duration.

TIMELINE

Six Stages That Affect the Time to Approval

Confirm the Application Strategy

Confirm the generic name, classification, certification standards, application category, and comparator. If testing begins before the strategy is finalized, additional testing or document revisions may be required.

Prepare Testing and Application Documents

Prepare performance and safety testing, clinical evaluation, STED, Essential Principles documentation, risk management, and labeling. The timeline varies substantially depending on which existing documents can be used.

PMDA Consultation

Prepare the issues and materials for consultation and follow the procedure for the applicable consultation category. Reflect the outcome of the consultation in the test plan and application materials.

Approval Review and Inquiry Responses

Respond to PMDA inquiries and, where necessary, revise application materials or provide additional explanations. The schedule should also include internal confirmation and coordination with overseas manufacturers needed to prepare responses.

QMS Conformity Assessment

Confirm the relevant manufacturing sites, product group, and availability of certificates of conformity, and proceed with the assessment in parallel with the approval review.

Post-Approval Launch Preparation

Confirm labeling and package insert, release decisions, reimbursement, and post-market safety management. The approval date and commercial launch date are not necessarily the same.

COST ITEMS

Six Cost Categories to Include in the Application Budget

PMDA review and related fees
These are the approval review fees applicable according to the application category and product. Because fee amounts are revised, check PMDA's current fee schedule at the time of application.
PMDA consultation fees
Fees are set for each consultation category. Estimate them based on the issues to be confirmed and the consultation category required, rather than simply on the number of consultations.
QMS conformity assessment fees
Required procedures and costs vary depending on the assessment category, manufacturing sites, product group, and certificate status.
Testing and evaluation costs
Depending on the product characteristics, costs may arise for performance, biological safety, electrical safety, software, sterilization, packaging, stability, clinical evaluation, and other areas.
Application dossier preparation costs
Allow for work needed to prepare the application form, STED, Essential Principles documentation, clinical evaluation, translations, and cross-document consistency checks.
Inquiry and additional-response costs
Allow for effort required for inquiry responses, additional analyses, document revisions, additional testing, and coordination with overseas manufacturers.

Review Fees and Face-to-Face Advice Fees

Check PMDA’s latest fee schedule for the amount and applicable category at the time of application. Review/QMS fees and consultation fees use separate tables; check the relevant category and revision date.

Check PMDA fees (Japanese)

Before estimating clinical evaluation work, use the CER preparation guide to define the evaluation scope and assess the available evidence.

DELAY FACTORS

Five Factors That Increase Time and Cost

The application category has not been determined
Because the comparator and scope of required documents may change, the test plan and estimate cannot be finalized.
The product to be submitted differs from the test sample
If differences in model, materials, process, sterilization conditions, or other aspects cannot be explained, additional evaluation may be required.
Documents are inconsistent
Revising and rechecking the application form, STED, test reports, clinical evaluation, and labeling takes additional time.
Responses from overseas are delayed
If design, manufacturing, or clinical information needed to answer inquiries cannot be obtained within the deadline, review activities may stop.
QMS preparation starts too late
If confirmation of the relevant manufacturing sites and required documents is delayed, the commercial launch date may remain uncertain even if the approval review is progressing.

To plan QMS work early, use the QMS conformity assessment preparation guide to confirm the relevant manufacturing sites and documents for your product and assessment route.

ESTIMATE PROCESS

How to Estimate Time and Cost from Product Documentation

01
Confirm the Application Category
Confirm whether the application is new, improved, or generic, whether clinical study results are available, and what comparator will be used.
02
Inventory Existing Documentation
Confirm the versions of overseas application materials, test reports, clinical documents, and QMS documents, and determine the extent to which they apply to the product planned for submission.
03
Estimate Missing Tests and Documents
Estimate the time and cost required for additional testing, translation, Japan-specific application documents, and draft labeling.
04
Build the Consultation, Review, and QMS Schedule
Organize PMDA consultation, submission, inquiry responses, and QMS conformity assessment into a timeline with the expected duration of each activity.
05
Allow for Changes and Additional Work
Build in time and cost for possible design changes, additional testing, inquiry responses, and document revisions.
For an example of organizing existing evidence and additional evaluation, see our pancreatic duct stent approval support case. It illustrates planning work, not a guarantee of the same timeline or cost.

For support with approval applications, dossier preparation, and QMS coordination, see Approval, Certification & Notification Support.

FAQ

Frequently Asked Questions About Approval Timelines and Costs

Is the Time from Submission to Approval Fixed?

No. It varies depending on the application category, completeness of the documentation, the nature of inquiries and response speed, additional testing, QMS conformity assessment, and other factors.

Can We Estimate the Application Cost Using Only PMDA Fees?

No. In addition to official fees, costs should be budgeted for testing, clinical evaluation, translation, application dossier preparation, QMS preparation, inquiry responses, and related work.

Does a PMDA Consultation Shorten the Application Timeline?

Simply holding a consultation does not necessarily shorten the review period. However, confirming major issues such as the application category, testing strategy, and clinical evaluation before submission can help avoid substantial rework after submission.

Can Existing Overseas Approval Reduce Testing Costs?

Existing test data may be usable, but the relationship to the product planned for submission, the applicable standards and versions, test samples, test conditions, and Japanese requirements must be confirmed.

At What Stage Can an Estimate Be Prepared?

If the intended use, structure and principle of operation, model configuration, overseas approval status, and existing test and clinical documentation are available, we can organize the additional points to confirm and the likely cost categories.

CONTACT

Review Testing, Documentation, and QMS Costs in Addition to Official Fees

We review product information, application category, overseas testing, clinical documentation, and QMS documents to identify the required work and overall schedule.