Japan medical-device preparation: category, local holder and authority handoff
PMDA’s acquired FAQ separates medical-device determination, the applicable approval/certification/notification route and the Japanese Marketing Authorization Holder’s procedures. A translated JMDN name alone does not settle these decisions. The local engagement should define who obtains the determination, prepares the evidence and manages the ongoing safety handoff.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Sourced criteria · Japan
What changes the service scope?
Decision or task
What the source describes
What to prepare
Is the product a medical device in the Japanese context?
PMDA directs formal device determination to the relevant authority or MHLW, with a local-holder consultation route. [2]
Prepare intended purpose, claims, technology and Japanese terminology; record the actual determination and authority correspondence.
Which route and local party carry out the procedure?
The FAQ describes approval, certification or notification depending on class, with procedures implemented by Marketing Authorization Holders in Japan. [1]
Ask the proposed holder to evidence the route, covered role and actual authorization; do not infer the route from a nomenclature-name match.
What establishes the proposed provider’s capability?
PMDA says it cannot provide a specific list of Marketing Authorization Holders and links to associations for information. [3]
Verify the actual candidate’s legal identity, relevant authorization and product scope directly; association or directory membership is insufficient.
Who owns ongoing safety communication?
The FAQ describes Japanese-holder safety reporting and, for Foreign Exceptional Approval, a designated-holder reporting relationship. [4]
Review which arrangement actually applies and define reporting, manufacturer communication and record ownership separately from initial translation/submission work.
The device class, route, current local-party licence scope, Japanese materials and the eligibility of any exceptional arrangement remain unresolved. This FAQ does not establish a universal MAH/DMAH route or identify an available commercial provider.
A scoped evidence and handoff plan
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Is the product a medical device in the Japanese context?
Prepare intended purpose, claims, technology and Japanese terminology; record the actual determination and authority correspondence.
Useful evidence: Product/claim description, translations and determination correspondence.
Which route and local party carry out the procedure?
Ask the proposed holder to evidence the route, covered role and actual authorization; do not infer the route from a nomenclature-name match.
What establishes the proposed provider’s capability?
Verify the actual candidate’s legal identity, relevant authorization and product scope directly; association or directory membership is insufficient.
Useful evidence: Dated role/authorization evidence, relevant scope and proposed deliverables.
Who owns ongoing safety communication?
Review which arrangement actually applies and define reporting, manufacturer communication and record ownership separately from initial translation/submission work.
Useful evidence: Actual engagement/route evidence and manufacturer–local-holder safety handoff.
Work packages and dependencies
Conditional: Japanese product determination, local-holder scope and evidence handoff — For this work package, agree the supported criteria, evidence access, covered entities/products and unresolved facts in the table above. Additional services require their own justified scope.
Questions for providers
Which exact actor, product or processing facts support the quoted scope, and what is still unresolved?
How will the listed records reach the responsible people, and who owns each change or authority request?
Which tasks and entities are excluded from the agreement, and which additional services need a separate assessment?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
