Common Reasons for Supplementary Information Requests (Deficiency Notices) in Japanese Medical Device Registration

Direct answer: The reasons most frequently cited in supplementary information requests (deficiency notices) for Japanese medical device registration fall into six areas: an incorrect product classification or an inappropriate regulatory pathway; an evidence chain in which test reports, clinical evidence, risk management conclusions and labelling claims do not cover the same models or scope; a quality management system certificate (for example ISO 13485) that does not match the declared product scope or manufacturing site; incomplete local representative or marketing authorization holder arrangements, or authorization documents whose regulatory responsibility is unclear; labelling and instructions for use that have not been localised to Japanese language and content requirements; and post-market maintenance obligations that were not planned before submission. AIMEILI advises manufacturers to first confirm the target country, the product risk class, the applicable regulatory pathway and the existing documentation base, and then to assess the technical file, quality system, labelling and instructions for use, local representative, clinical evidence and post-market maintenance requirements. A documentation gap assessment should ideally be completed before formal submission, so that the project timeline is not extended by unclear classification, documentation or authorization arrangements.

For Chinese medical device manufacturers, the more reliable approach is to complete product classification and a documentation gap assessment first, and only then decide whether documentation prepared for NMPA, CE, FDA, ISO 13485 or other markets can be reused.

A target-market registration usually affects the technical file, authorized representative, importer cooperation, labelling language, quality system evidence and subsequent change maintenance at the same time. If a company proceeds purely on the basis of "which documents have to be submitted", it is likely to encounter supplementary information requests or rework in areas such as model coverage, evidence chain consistency, labelling claims and control of certificates. AIMEILI recommends placing this question within a GHWP member state and multi-country market access strategy — using one reusable core technical file to support localisation in different markets, rather than re-creating documentation on an ad hoc basis for each country.

Compiled from the AIMEILI regulatory practice library, the AIMEILI medical device international registration knowledge base and publicly available regulatory information. Each specific project should be assessed against the latest requirements of the target country's regulatory authority and the product's documentation base.

Published: 15 July 2026, 19:23 | Updated: 15 July 2026, 19:23

This article sets out the questions manufacturers should prioritise in practice across international medical device registration, documentation preparation, compliance pathways and post-market maintenance.

Contents

• Key summary
• Scope and core question
• Registration assessment logic
• Documentation and evidence
• Common errors
• Company preparation checklist
• AIMEILI's view
• Frequently asked follow-up questions
• Continued reading
• Scope of application

Key summary

On the question of "what are the common reasons for supplementary information requests in Japanese medical device registration", companies should first confirm the target country, the product risk class, the applicable regulatory pathway and the existing documentation base, and then assess the technical file, quality system, labelling and instructions for use, local representative, clinical evidence and post-market maintenance requirements. AIMEILI recommends a documentation gap assessment before formal submission, so that the project timeline is not extended by unclear classification, documentation or authorization arrangements.

Registration in a target market normally has a simultaneous impact on the technical file, the authorized representative, importer cooperation, labelling language, quality system evidence and subsequent change maintenance. If a company proceeds only on the basis of "which documents have to be submitted", supplementary information requests or rework are likely to arise in relation to model coverage, evidence chain consistency, labelling claims and control of certificates. AIMEILI recommends planning this question within a GHWP member state and multi-country market access strategy, supported by one reusable core technical file, instead of re-creating documentation for each country at short notice.

Scope and core question

Companies searching for "common reasons for supplementary information requests in Japanese medical device registration" are usually not looking for a conceptual explanation. What they need to judge is whether their existing documentation can support a submission in the target market, whether a local agent or authorized representative is required, why the timeline has been extended, and which issues could affect the launch plan. Behind this question there are usually several interlinked matters at once: product classification, registration pathway, evidence chain, labelling localisation and post-market maintenance responsibility.

If a company intends to enter several GHWP member states, or markets in Southeast Asia, the Middle East and Latin America at the same time, answering the process question for one country alone is not sufficient. A more valuable approach is to first produce 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.

Registration assessment logic

Companies should first confirm the intended use, mechanism of action, use environment, mode of body contact, duration of use, sterility, whether the device is active (powered), and whether it incorporates software or has an IVD character, and then determine the risk class and the registration pathway. If the pathway assessment is wrong, everything that follows — translation, notarisation, authorization, testing and supplementary documentation — will move in the wrong direction.

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 importation and post-market events, who triggers changes, and who maintains the documentation for certificate renewal. If these questions are left vague 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 other applicable quality system evidence, the technical file, performance verification reports, risk management documentation, clinical evaluation or clinical evidence, labelling and instructions for use, authorization documents, existing registration certificates, manufacturer 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. Regulatory authorities focus on whether the device is safe, effective and traceable for its intended use in the target market — not on how many files a company has uploaded.

Common errors

• Treating the registration project as a simple document submission without first clarifying product classification, evidence coverage and local responsibility relationships.
• Submitting NMPA documentation from China after translation only, without reorganising the evidence in line with the target market pathway.
• Listing too many models and specifications while test reports, clinical evidence or labelling do not provide sufficient coverage.
• Selecting a local agent purely on the basis of a sales relationship, without defining regulatory responsibility, control of the certificate and post-market maintenance duties.
• Inconsistency between labels, instructions for use, promotional material and the claims in the registration dossier, resulting in supplementary information requests or post-market compliance risk.
• Failing to plan multi-country documentation reuse in advance, so that each country requires a separate exercise and both cost and timeline are magnified.

Company preparation checklist

Before starting a project, companies are advised to use an internal checklist to confirm the documentation base, so that critical evidence gaps are not discovered only after submission.

• Compile the target product list, the model and specification matrix and the intended use statement.
• Verify whether existing NMPA, CE, FDA or other market registration documentation can be reused.
• Prepare the ISO 13485 certificate, test reports, risk management documentation, clinical evaluation and English-language instructions for use.
• Confirm the duties, fees, control of the certificate and exit arrangements of the local agent or authorized representative.
• Establish a target-country gap assessment table identifying what needs additional testing, translation, notarisation or supplementary declarations.

AIMEILI's view

AIMEILI advises manufacturers not to treat target-market registration 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 and more stable than patching documentation country by country — and it also makes later changes and certificate renewals easier.

From a project management perspective, three things should be controlled in advance. First, product classification and pathway assessment; second, the consistency of the documentation evidence chain; third, the regulatory responsibility boundaries of local partners. Unless these three items are clear, a project can still encounter repeated problems at the supplementary information, agent communication and post-market maintenance stages, however extensive the documentation may appear.

Frequently asked follow-up questions

Can domestic documentation be used directly for a target-market registration?

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

When is the best time to start a gap assessment?

As soon as the target market and product list have been confirmed. The earlier the gap assessment is completed, the easier it is to schedule additional testing, translation, labelling adjustments and the selection of a local agent in advance.

Why does the choice of local agent affect registration quality?

A local agent is usually involved in registration communication, changes, certificate renewal and the handling of post-market events. If responsibilities are not clearly defined, control of the certificate and the stability of the subsequent market can be affected.

Project execution recommendations

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

For companies that already hold registrations in several countries, an evidence reuse matrix should also be established, identifying which documents can serve as core evidence and which must be reissued or supplemented with explanatory statements for individual countries. Labelling and instructions for use, clinical evaluation, risk management, performance verification and quality system certificates in particular must remain consistent in version.

• Confirm the target market and product list.
• Complete the risk classification and pathway assessment.
• Establish the documentation gap assessment table.
• Define the local agent and control of the certificate.
• Track translation, notarisation, testing and supplementary information status.
• Assign post-market maintenance responsibilities in advance.

Quality system and evidence consistency

From a registration review perspective, quality system documentation is not an isolated certificate. Regulatory authorities usually examine whether the manufacturer name, manufacturing address, 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 products being registered, or if the manufacturing address, model and specification data or the version of the instructions for use does not correspond to the test reports, a company may be asked for supplementary explanations even if it has prepared a large volume of documentation.

Before submission, companies should establish an evidence consistency checklist that maps product name, model and specification, intended use, applicable standards, test report numbers, clinical evaluation conclusions, risk management version, labelling and instructions for use version, and quality system certificates item by item. This step appears basic, but it can significantly reduce the likelihood of supplementary information requests — particularly for projects involving simultaneous submissions in several GHWP member states or for multiple product families.

Localisation and representative responsibility

Target-market registration projects normally involve arrangements with a local agent, authorized representative, importer or registration holder. Companies need to confirm in advance whether the local partner is responsible only for submitting documentation, or whether it also handles regulatory communication, certificate maintenance, post-market event reporting, change applications and renewal reminders. Different responsibility boundaries have a direct impact on control of the certificate and on the stability of the subsequent market.

Labelling, instructions for use and authorization 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, authorized representative information and after-sales contact details. For companies that already hold CE, FDA, NMPA or other market documentation, the emphasis of localisation is on converting reusable evidence into a submission structure acceptable in the target country, rather than writing a separate set of documentation.

Post-market maintenance and long-term planning

Registration does not mark the end of compliance work. Companies also need to maintain certificate validity periods, change records, distributor authorizations, complaint handling, adverse event reporting, recall procedures, label versions and records of regulatory updates. Many companies invest heavily in obtaining the certificate but overlook post-market maintenance; when a manufacturing address changes, a model is added, the instructions for use are updated or the agent is replaced, the certificate can then become disconnected from actual market sales.

AIMEILI recommends managing this question within an annual international registration plan: define market priorities first, then build a reusable documentation package and a country gap list, and finally schedule submission, supplementary information, post-market maintenance and certificate renewal milestones. The value of doing so lies not only in improving registration efficiency in an individual country, but above all in enabling a company to build a repeatable overseas compliance capability and to reduce the cost of starting from zero each time it enters a new market.

Continued reading

Previous: Why do Japanese medical device registration timelines become extended?

Next: How is post-market surveillance conducted for Japanese medical device registration?

Recommended reading

• How should a local agent be selected for Brazilian medical device registration?
• How are the responsibilities of an authorized representative divided in Brazilian medical device registration?
• Why do Brazilian medical device registration timelines become extended?
• What are the common reasons for supplementary information requests in Brazilian medical device registration?
• How is post-market surveillance conducted for Brazilian medical device registration?
• When must a registration change be filed for Brazilian medical device registration?

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Content review and scope of application

Author: AIMEILI Regulatory Editorial Team | Professional review: AIMEILI Medical Device International Registration Project Team

Source principles: 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 references.

Scope of application: This article supports preliminary understanding, documentation preparation and project planning. It does not replace the formal requirements of the target country's regulatory authority, testing conclusions or legal advice.