Japan is often described as an approval market, but approval is only one part of the structure. A Japanese marketing authorisation holder has to exist, the manufacturing site has to be registered, and the unit has to fit the approved or certified device. For used equipment, the holder\’s willingness is often the deciding factor.

The Japanese Approval Landscape

Japan regulates medical devices under the Pharmaceuticals and Medical Devices Act. The PMDA reviews applications, the MHLW grants approvals, and a Japanese marketing authorisation holder is responsible for the device in the market. Used units sit inside that structure rather than outside it.

The PMDA is the review agency, not the only decision-maker. The Ministry of Health, Labour and Welfare grants approvals, while registered certification bodies handle many Class II devices. The marketing authorisation holder holds the licence to supply the device and carries the post-market obligations that follow.

Comparable questions arise under FDA rules, the EU Medical Device Regulation 2017/745, MHRA guidance and TGA requirements, while WHO guidance frames the shared principles. The Japanese answer is still set by the PMDA and the holder. The system is built around a device and a responsible local entity, not around a shipment. That is why a Japanese partner\’s first question is usually not \”what is the price\” but \”which device is approved, and who will hold it\”. A seller who cannot answer those questions has not started the market entry process.

Class and Route: Approval Versus Certification

Class I devices are notified; many Class II devices are certified by a registered certification body; Class III and Class IV devices go through PMDA review and MHLW approval. The class decides the route, and the route decides the timeline.

Japan uses a four-class system, with Class I at the low-risk end and Class IV for the highest-risk devices. The route is not a simple function of the class in every case: some Class II devices require approval rather than certification, and the designation of the device matters. The marketing authorisation holder and the regulatory consultant normally confirm the route before a dossier is prepared.

The Marketing Authorisation Holder

The marketing authorisation holder is the Japanese entity licensed to place the device on the market and accountable for its post-market obligations. A foreign manufacturer cannot hold that role directly.

The holder must have the appropriate licence, maintain the approval or certification, keep the technical file, operate a quality management system and handle complaints, recalls and safety reporting. It is the local face of the device to the regulator, and it is the party that decides whether a particular used unit can be supplied under its approval.

That makes the holder relationship commercial as well as regulatory. A holder that already has the device in its portfolio may be able to add a used unit with less work than one starting from scratch. A holder that does not understand the used-equipment model may refuse the unit even when the device is approved. The conversation should happen before the unit is shipped, not after it arrives.

Used Equipment: What Practically Gets Through

Used equipment is not outside the PMD Act. A unit can be imported if it fits an approved or certified device and the holder accepts it, with condition and history evidence that supports the application.

In practice, several filters decide whether a used unit is viable. The device category matters, because some categories are more readily accepted than others. The service history matters, because the holder has to be satisfied that the unit is within the approved configuration. The software version matters, because an update can move the unit away from the approved version. Single-use devices raise a separate set of labelling and reprocessing questions that the holder will not want to answer casually.

There is no per-unit approval for a used device. The approval or certification covers the device, and the unit is supplied under it if it matches. A seller who asks \”can you approve my unit\” is asking the wrong question; the useful question is \”does this unit fit the device you have approved, and what evidence do you need to confirm it\”.

Age is not a single number. What matters is the service life of the assembly, the availability of parts and the manufacturer\’s support position. A ten-year-old unit with a recent major service and a documented software update may be more viable than a five-year-old unit with no history. The holder will want to know which assemblies were replaced, whether the replacements were OEM or equivalent, and whether the manufacturer still supports the model. Where support has ended, the holder may still accept the device, but the post-market risk becomes part of the decision. That is why the condition file should be written for a regulator, not for a buyer, and why a photograph of the nameplate is not a substitute for a service record.

Japanese Language Requirements

Labels, instructions and safety information for the Japanese market must be in Japanese and must match the approved or certified content. A used unit with an English-only manual is not ready for the market.

Translation is a controlled process, not a desktop exercise. The holder reviews the Japanese text against the approved content, and the label must identify the holder and the required device information. A sticker or overlay can be acceptable if it is controlled and does not obscure required markings; a replacement label that changes the device identity is a different matter.

The manual should match the software version and configuration supplied. A Japanese manual for a different version creates a safety and a regulatory problem at once. Keep the approved artwork, the translation record and a photograph of the applied label in the unit file.

QMS and Site Considerations

The manufacturing site, including a foreign site, must be registered and subject to the Japanese quality management system requirements. Refurbishment work can raise the question of whether a new site or a new registration is required.

Japan\’s QMS requirements apply to the site that manufactures the device, and foreign manufacturers must be registered with the PMDA for the relevant categories. A refurbisher that performs work beyond servicing may be treated as a manufacturing site, which changes the registration and audit picture. The holder and the manufacturer need to agree who is responsible for the site before the work begins.

The QMS evidence should cover the processes that affect the device: design control where applicable, purchasing, production, inspection, corrective action and records. A certificate alone is not the whole answer; the holder needs to know that the site and the device family are within its scope.

Documentation for a Japanese Partner

A Japanese partner should receive a file that connects the device approval, the holder and the specific unit. The table below is the working set; each missing item should be recorded and assessed rather than replaced by an assurance.

Records and checks: the Japanese entry file

Timelines and Cost Drivers

Timelines are driven by the route, the completeness of the dossier and the availability of the holder and the reviewers. Approval and certification are not off-the-shelf processes, and a used unit adds the condition assessment to an already document-heavy application.

Translation, QMS review, clinical evaluation and any local testing add time before the application is complete. The holder\’s own review and the regulator\’s questions add more. A project plan that starts with the freight date rather than the dossier date will usually miss the freight date.

The cost drivers follow the same pattern: the route, the evidence, the translation, the QMS work and the holder\’s role. A used unit that requires a new application is a different project from one that fits an existing approval. The difference should be established before the commercial offer is made. The timeline context around recent EU and Japanese updates is covered in the article on EU MDR and Japan PMDA updates; this article deals with the used-unit route.

If you are preparing a Japanese entry file and want the approval route, holder and condition evidence reviewed together, send the model and what you already hold to the HHG team. More guides on records, refurbishment and cross-border entry are in the Knowledge section.