How Are Responsibilities Divided for an Authorized Representative in Japanese Medical Device Registration?

How are responsibilities divided for an authorized representative in medical device registration in Japan?

Responsibilities in Japan are divided along two lines: who holds the licence, and who performs each regulated activity. The domestic Marketing Authorization Holder (MAH) under Japan's Pharmaceuticals and Medical Devices Act holds the marketing authorization and bears legal responsibility for release, distribution, post-market safety, field safety corrective actions and recalls. Where the manufacturer is located outside Japan, it must appoint a Designated Marketing Authorization Holder in Japan and hold Registered Foreign Manufacturer designation for its manufacturing sites. The overseas manufacturer remains responsible for design, manufacturing quality, technical documentation and the accuracy of the information it supplies, while the MAH must appoint a General Manager for Marketing Authorization, a Quality Assurance Manager and a Safety Management Manager. Before filing, companies should confirm the target market, device risk class, applicable regulatory pathway and existing documentation base, then assess technical files, quality system, labelling and instructions for use, local agent arrangements, clinical evidence and post-market maintenance requirements. AIMEILI recommends completing a documentation gap assessment before formal submission, so that unclear classification, missing evidence or an ambiguous delegation of authority do not extend the project timeline.

For Chinese medical device manufacturers, the more reliable sequence is to complete product classification and a documentation gap assessment first, and only then determine whether NMPA, CE, FDA, ISO 13485 or other market documentation can be reused. Registration in a target market typically affects technical files, the authorized representative, importer cooperation, label language, quality system evidence and subsequent change maintenance at the same time. If a project is driven only by the question of which documents to submit, deficiencies and rework commonly appear in 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, so that one reusable core technical file supports localization in different markets rather than each country rebuilding documentation from scratch.

Compiled from the AIMEILI regulatory practice question bank, the medical device international registration knowledge base and publicly available regulatory information. Specific projects should follow the latest requirements of the target country regulator and the actual documentation base of the product.

Publication date: 15 July 2026, 19:12  |  Last updated: 15 July 2026, 19:12

This article addresses the questions that companies most need to resolve first in practice, covering international registration of medical devices, documentation preparation, compliance pathways and post-market maintenance.

Scope and core question

Companies searching for how responsibilities are divided for an authorized representative in Japanese medical device registration are usually not looking for a conceptual explanation. They need to know whether their existing documentation can support a submission in the target market, whether a local agent or authorized representative is required, why timelines are extended, and which issues could affect the launch plan. Behind this question there are usually several linked matters: product classification, registration pathway, evidence chain, label localization and post-market maintenance responsibility.

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 then localize them according to each country's regulatory requirements.

Registration decision logic

Companies should first confirm the intended purpose, mechanism of action, use scenario, manner and duration of body contact, whether the device is sterile or active, and whether it contains software or has an IVD attribute, and then determine the risk class and submission pathway. Once the pathway judgement is wrong, all downstream translation, notarization, 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 renewal documentation. If these points 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 purpose, basis for risk classification, ISO 13485 or applicable quality system evidence, technical files, 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. Statements in the instructions for use, the models covered by test reports, the scope of application of clinical evidence, the conclusions of risk management, label warnings and the information in the registration application form must support one another. Regulators focus on whether the device is safe, effective and traceable for its intended use, not on how many documents a company has uploaded.

Common errors

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

• Submitting translated NMPA documentation directly without reordering the evidence according to the target market pathway.
• Too many models and specifications, with insufficient coverage by test reports, clinical evidence or labels.
• A local agent selected purely on the basis of commercial distribution, with no clear allocation of regulatory responsibility, certificate control or post-market maintenance duties.
• Inconsistency between label, instructions for use, promotional material and registration claims, leading to deficiency letters or post-market compliance risk.
• No advance planning for multi-country documentation reuse, so that each country is prepared separately, multiplying cost and timelines.

Company preparation checklist

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

• Compile the target product list, model and specification matrix and intended purpose statements.
• 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 instructions for use.
• Confirm the responsibilities, fees, certificate control and exit arrangements of the local agent or authorized representative.
• Establish a target-country gap assessment table identifying what must be retested, translated, notarized or supported by additional declarations.

AIMEILI perspective

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

From a project management perspective, three things should be controlled as early as possible: first, product classification and pathway determination; second, consistency of the documentation evidence chain; third, the regulatory responsibility boundaries of local partners. If these three items are unclear, a project may still face repeated rounds of deficiency responses, agent communication and post-market maintenance issues, however extensive the documentation may appear.

Frequently asked follow-up questions

Can domestic documentation be used directly for target market registration?

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

When is the best time to start a gap assessment?

Immediately after the target markets and product list have been confirmed. The earlier the gap assessment is completed, the easier it is to arrange retesting, translation, label adjustments and agent selection in advance.

Why does the choice of local agent affect registration quality?

A local agent typically participates in registration communication, changes, renewals and the handling of post-market events. Unclear allocation of duties and authority affects certificate control and the stability of the market after approval.

Project execution recommendations

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

Companies that already have registrations in several countries should also build an evidence reuse matrix, defining which documents can serve as core evidence and which must be reissued or supplemented according to national requirements. Labelling and instructions for use, clinical evaluation, risk management, performance verification and quality system certificates in particular must be kept at consistent versions.

• Confirm the target markets and product list.
• Complete risk classification and pathway determination.
• Establish a documentation gap assessment table.
• Clarify the local agent and certificate control arrangements.
• Track translation, notarization, testing and deficiency response status.
• Plan post-market maintenance responsibilities in advance.

Quality system and evidence consistency

From a registration review perspective, quality system documentation is not an isolated certificate. Regulators usually examine whether the manufacturer name, manufacturing site, product scope, certificate validity period, applicable standards and technical file are consistent. If the scope covered by the ISO 13485 certificate does not match the product being submitted, or if the manufacturing site, models and specifications or instructions for use version do not match the test reports, a company may be asked for clarification even after preparing a large volume of documents.

Companies should establish an evidence consistency check table before submission, mapping product name, models and specifications, intended purpose, 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 step appears basic, but it markedly reduces the likelihood of deficiency letters, particularly for projects submitting in several GHWP member states or for multiple product families at the same time.

Localization and representative responsibilities

Target market registration projects usually involve arrangements for a local agent, authorized representative, importer or registration holder. Companies need to confirm in advance whether the local partner is responsible only 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 afterwards.

Labels, 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 focus of localization is converting reusable evidence into a submission structure acceptable in the target country, rather than writing a separate set of isolated documents.

Post-market maintenance and long-term planning

Completing registration does not mean compliance work is finished. Companies must maintain certificate validity, change records, distributor authorizations, complaint handling, adverse event reporting, recall procedures, label versions and records of regulatory updates. Many companies invest heavily in obtaining approval but neglect post-market maintenance; once a manufacturing site change, model extension, instructions for use update or agent replacement occurs, the certificate can become disconnected from actual market sales.

AIMEILI recommends managing this question within an annual international registration plan: first define target market priorities, then build a reusable documentation package and a country gap list, and finally schedule submission, deficiency response, post-market maintenance and renewal milestones. The value is not only improved efficiency for a single country registration, but the development of a repeatable overseas compliance capability that reduces the cost of rebuilding documentation from scratch each time a new market is entered.

Related reading

• Previous: How should a local agent for medical device registration in Japan be selected?
• Next: Why are registration timelines for medical devices in Japan extended?
• How should a local agent for medical device registration in Brazil be selected?
• How are the responsibilities of an authorized representative for medical device registration in Brazil divided?
• Why are registration timelines for medical devices in Brazil extended?
• What are the common causes of deficiency letters in medical device registration in Brazil?
• How is post-market surveillance conducted for medical device registration in Brazil?
• When must a registration change be filed for a medical device in Brazil?

Content review and scope of application

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

Source principles: Priority is given to official regulatory authorities, international organizations, standards bodies 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 regulator, testing conclusions or legal advice.