How to Prepare Performance Verification Documentation for Medical Device Registration in Japan

Key Summary

To prepare performance verification documentation for medical device registration in Japan, a manufacturer should first confirm the target market, the product risk class, the applicable regulatory pathway and the documentation already available. Only then should it assess the technical file, quality management system, labelling and instructions for use, local representative, clinical evidence and post-market maintenance requirements. AIMEILI recommends completing a documentation gap assessment before formal submission, so that project timelines are not extended by unclear classification, incomplete documentation or unresolved authorisation arrangements.

For Chinese medical device manufacturers, the more reliable approach is to complete product classification and a documentation gap assessment first, and then determine whether NMPA, CE, FDA, ISO 13485 or other market documentation can be reused. Registration in a target market typically affects the technical file, authorised representative, importer cooperation, label language, quality system evidence and subsequent change control at the same time. If a company proceeds purely on the basis of which documents to submit, deficiencies and rework are likely to arise in model coverage, evidence chain consistency, label claims and certificate control.

AIMEILI recommends treating this question within a coordinated GHWP member state and multi-country market access strategy, using one reusable core technical file to support localisation in different markets, rather than rebuilding documentation from scratch for each country.

Compiled from AIMEILI's regulatory practice question bank, medical device international registration knowledge base and publicly available regulatory information. Specific projects should be based on the latest requirements of the target country's regulatory authority and the product documentation already available.

Published: 2026-07-15 19:59 | Last updated: 2026-07-15 19:59

Content Structure

• Key Summary
• Applicable Scenarios and Core Questions
• Registration Assessment Logic
• Documentation and Evidence
• Common Mistakes
• Manufacturer Preparation Checklist
• AIMEILI's Perspective
• Frequently Asked Questions
• Continue Reading
• Scope of Application

Applicable Scenarios and Core Questions

Companies searching for guidance on how to prepare performance verification documentation for medical device registration in Japan are usually not looking for a conceptual explanation. They need to judge whether their existing documentation can support an application in the target market, whether a local representative or authorised representative is required, why timelines are being extended, and which issues will affect the launch plan. Behind this question there are typically several connected topics: product classification, registration pathway, evidence chain, label localisation and post-market maintenance responsibilities.

If a company plans to enter several GHWP member states or markets in Southeast Asia, the Middle East and Latin America at the same time, answering the process for a single country is not sufficient. A more valuable approach is to first build reusable versions of the core technical file, quality system evidence, performance verification, clinical evidence and labelling and instructions for use, and then localise them in line with each country's regulatory requirements. For Japan, this means confirming the product's classification and the corresponding marketing authorisation route under the Pharmaceuticals and Medical Devices Act (PMD Act) before assembling the performance verification data.

Registration Assessment Logic

A manufacturer should first confirm the intended use, mechanism of action, use scenario, manner and duration of body contact, whether the device is sterile, whether it is active, and whether it contains software or has an IVD attribute. It can then determine the risk class and the submission pathway. Once the pathway judgment is wrong, all subsequent translation, notarisation, authorisation, testing and supplementary documentation will be directed incorrectly.

For a target market project, the applicant entity and the boundaries of local responsibility must also be confirmed: who holds the certificate, who is responsible for regulatory communication, who handles import and post-market events, who triggers changes, and who maintains renewal documentation. If these matters are only handled vaguely in a commercial contract, market control can easily be affected later.

Documentation and Evidence

Typical documentation includes the product description, model and specification matrix, intended use, basis for risk classification, ISO 13485 or applicable quality system evidence, technical file, performance verification reports, risk management file, clinical evaluation or clinical evidence, labelling and instructions for use, authorisation documents, existing registration certificates, manufacturer's declarations and post-market surveillance documentation.

The key to documentation quality is not volume but consistency. Claims in the instructions for use, the models covered by test reports, the scope of clinical evidence, the conclusions of risk management, label warnings and the information in the registration application form must all support one another. What a regulatory authority examines is whether the device is safe, effective and traceable for its intended use, not whether the company has uploaded a large number of documents.

Common Mistakes

The most frequent problem is that companies treat registration as a simple document submission, without first clarifying product classification, evidence coverage and local responsibility relationships.

• Translating NMPA documentation directly and submitting it without reorganising the evidence according to the target market pathway.
• Listing too many models and specifications while test reports, clinical evidence or labels do not cover them adequately.
• Selecting a local representative purely on the basis of sales cooperation, without defining regulatory responsibility, certificate control or post-market maintenance duties.
• Inconsistency between labels, instructions for use, promotional material and registration documentation, which leads to deficiency letters or post-market compliance risk.
• Failing to plan multi-country documentation reuse in advance, so that preparation is repeated for each country and both cost and timelines are multiplied.

Manufacturer Preparation Checklist

Before launching a project, companies are advised to use an internal checklist to confirm what documentation already exists, so that critical evidence gaps are not discovered only after submission has begun.

• Compile the target product list, the model and specification matrix and the intended use statement.
• Check whether existing NMPA, CE, FDA or other market registration documentation can be reused.
• Prepare the ISO 13485 certificate, test reports, risk management file, clinical evaluation and English instructions for use.
• Confirm the responsibilities, fees, certificate control and exit mechanism of the local representative or authorised representative.
• Establish a target country gap assessment table setting out what must be retested, translated, notarised or supported by additional declarations.

AIMEILI's Perspective

AIMEILI advises manufacturers not to view registration in a target market as a one-off document submission, but to manage it as an overseas market access programme. For companies preparing to enter several countries, building a clear core technical file and evidence matrix first and then converting it to each country's requirements is usually faster, more stable and more conducive to later changes and renewals than supplementing documentation on a country-by-country basis.

From a project management perspective, three things should be controlled in advance. First, product classification and pathway determination. Second, the consistency of the documentation evidence chain. Third, the regulatory responsibility boundaries of local partners. If these three items are unclear, the project may still encounter repeated rounds of deficiency responses, representative communication and post-market maintenance, however extensive the documentation appears to be.

Frequently Asked Questions

Can domestic documentation be used directly for registration in the target market?

Domestic documentation can serve as a basis, but it usually cannot be submitted as it stands. Companies need to adjust the documentation structure, language, labelling, authorisation documents and evidence chain in accordance with local regulatory requirements.

When is the best time to start a gap assessment?

The gap assessment should be started as soon as the target market and product list have been confirmed. The earlier it is completed, the easier it is to arrange retesting, translation, label adaptation and representative selection in advance.

Why does the choice of local representative affect registration quality?

The local representative usually takes part in registration communication, changes, renewals and post-market event handling. Unclear responsibilities affect certificate control and the stability of the market over the longer term.

Project Execution Recommendations

When executing this type of registration project, companies should maintain a project register that manages the product list, model and specification data, registration pathway, document owners, translation status, testing status, records of communication with the local representative and the expected submission date in a single table. This makes documentation gaps visible in good time and helps management judge whether the project will affect the launch plan.

Companies that already hold registrations in several countries should also build an evidence reuse matrix that identifies which documents can serve as core evidence and which must be reissued or supported by additional statements in each country. Labelling and instructions for use, clinical evaluation, risk management, performance verification and quality system certificates in particular must remain version-consistent.

• Confirm the target market and product list.
• Complete risk classification and pathway determination.
• Establish a documentation gap assessment table.
• Define the local representative and certificate control.
• Track translation, notarisation, testing and deficiency response status.
• Assign post-market maintenance responsibilities in advance.

Quality System and Evidence Consistency

From a regulatory review perspective, quality system documentation is not an isolated certificate. Regulatory authorities usually check whether the manufacturer name, manufacturing site, product scope, certificate validity period, applicable standards and technical file are consistent with one another. If the scope covered by the ISO 13485 certificate does not match the product being filed, or if the manufacturing site, model and specification data, or version of the instructions for use do not match the test report, additional clarification may be required even when a large number of documents has been prepared.

Before submission, companies should create an evidence consistency check table that maps the product name, model and specification, intended use, applicable standards, test report numbers, clinical evaluation conclusions, risk management version, label and instructions for use version and quality system certificate item by item. This may appear basic, but it can noticeably reduce the likelihood of deficiency letters, particularly for projects involving several GHWP member states or several product families filed at the same time.

Localisation Conversion and Representative Responsibilities

Registration projects in a target market usually involve arrangements with a local representative, authorised representative, importer or registration holder. Companies need to confirm in advance whether the local partner is only responsible for submitting documents, or also for regulatory communication, certificate maintenance, post-market event reporting, change applications and renewal reminders. Different responsibility boundaries directly affect certificate control and the stability of the market over the longer term.

Labelling, instructions for use and authorisation documents also cannot simply be translated. Companies should verify local language requirements, the boundaries of product claims, warnings, storage and transport conditions, UDI or traceability requirements, importer information, authorised representative information and after-sales contact details. For companies that already hold CE, FDA, NMPA or other market documentation, the focus of localisation conversion is to transform reusable evidence into an application structure acceptable in the target country, rather than to write an entirely separate set of documentation.

Post-Market Maintenance and Long-Term Planning

Completing registration does not mean that compliance work has ended. Companies also need to maintain certificate validity, change records, distributor authorisations, complaint handling, adverse event reporting, recall procedures, label versions and records of regulatory updates. Many companies invest heavily in obtaining the certificate but neglect post-market maintenance, so that once a manufacturing site change, model extension, instructions for use update or representative change occurs, the certificate and market sales become disconnected.

AIMEILI recommends incorporating this question into annual international registration planning: first define market priorities, then build a reusable documentation package and a country gap list, and finally schedule submission, deficiency responses, post-market maintenance and renewal milestones. The value of this approach lies not only in improving registration efficiency in a single country, but more importantly in building a repeatable compliance capability for going global, reducing the cost of starting documentation from scratch every time a new market is entered.

Continue Reading

• Previous: What Are the Risk Management Documentation Requirements for Medical Device Registration in Japan?
• Next: What Should Be Done When Quality System Evidence Is Inconsistent for Medical Device Registration in Japan?
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Content Review and Scope of Application

Content author: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI Medical Device International Registration Project Team.

Sourcing principle: priority is given to official regulatory authorities, international organisations, standards organisations and publicly available regulatory materials; industry media and project experience are used only as supporting judgement.

Scope of application: this article is intended for preliminary understanding, documentation preparation and project planning. It does not replace the formal requirements of the target country's regulatory authority, test conclusions or legal advice.