Medical device manufacturers entering Japan frequently treat customs clearance and product regulatory approval as a single problem to solve. They are not. Importing a medical device or healthcare equipment product into Japan requires satisfying two entirely separate compliance frameworks: the product regulatory layer administered by the Ministry of Health, Labour and Welfare (厚生労働省, MHLW) under the Pharmaceutical and Medical Device Act (薬機法, also called the PMD Act), and the customs importer-of-record layer governed by the Customs Act (関税法). An Importer of Record (IOR) appointment resolves the customs question. It does not substitute for PMD Act clearance, and it does not create, or confer, Marketing Authorization Holder (製造販売業者, MAH) status. Both layers must be addressed in parallel, and the sequencing matters.
The Two-Layer Compliance Problem
Every medical device import to Japan sits at the intersection of two distinct regulatory regimes administered by two distinct agencies.
Layer one: product regulatory approval under the PMD Act. The Pharmaceutical and Medical Device Act (薬機法) governs whether a product may lawfully be placed on the Japan market. MHLW and the Pharmaceuticals and Medical Devices Agency (医薬品医療機器総合機構, PMDA) administer the approval and certification process. Without the relevant approval or certification for the device class in question, the product cannot be sold commercially in Japan regardless of how cleanly it clears customs.
Layer two: the customs importer-of-record structure under the Customs Act. Japan's Customs Act (関税法) governs who is the legal importer named on the import declaration (輸入申告). Japan Customs' October 2023 reform on disposition rights clarified that the declared importer must hold genuine legal rights over the goods at the point of importation. A foreign manufacturer without a Japan entity cannot simply file a Japan customs declaration in its own name without appointing an Attorney for Customs Procedures (税関事務管理人) and registering for consumption tax purposes, or alternatively using an IOR provider that takes title.
Neither layer substitutes for the other. An IOR appointment gives you a legal importer on the customs declaration. It does not give you an MAH. PMD Act clearance gives you the right to market the device in Japan. It does not resolve who appears on the import declaration. Both must be in place before commercial shipments can lawfully proceed for regulated device classes.
PMD Act Overview for Importers: Device Classes and the MAH
The Pharmaceutical and Medical Device Act (薬機法) classifies medical devices into four risk classes. The class determines the approval or certification pathway, the regulatory timeline, and the nature of oversight.
Class I devices are general medical devices with minimal risk. They do not require pre-market approval; a notification filing with the prefectural government is sufficient. Examples include surgical gloves and tongue depressors. Timeline from filing to importation is relatively short.
Class II devices are specified controlled medical devices with relatively low to moderate risk. They require certification from a registered third-party certification body (登録認証機関). Examples include MRI contrast agents, certain diagnostic electrodes, and powered wheelchairs. Certification timelines typically range from several months to over a year depending on the certification body and submission readiness.
Class III and Class IV devices carry significant or the highest risk and require pre-market approval from MHLW, with PMDA conducting the technical review. Implantable cardiac devices, stents, and high-risk diagnostic equipment fall in this tier. Approval timelines for Class III and IV can extend to multiple years, and the regulatory affairs investment is substantial.
What is a Marketing Authorization Holder (MAH)? The MAH (製造販売業者) is the Japan-licensed entity legally responsible for the device once it enters commerce. The MAH holds the approval or certification for the device and is responsible for post-market surveillance, adverse event reporting, and quality management system (QMS) compliance. Every regulated medical device entering the Japan market for commercial purposes requires an MAH.
Why a foreign manufacturer without a Japan entity cannot be the MAH directly. A foreign manufacturer can obtain MAH status in Japan only indirectly. The standard pathway is to partner with a Japan-based entity that holds an MAH licence. The foreign manufacturer then separately pursues Foreign Manufacturer Accreditation (外国製造業者認定) from MHLW, which registers the overseas manufacturing site and is a precondition for the Japan MAH to hold approval for devices made at that site. Foreign Manufacturer Accreditation is not the same as holding MAH status: the accreditation recognises the manufacturing site; the MAH remains the Japan-licensed entity that holds the market approval.
For medtech companies without a Japan subsidiary, this means the MAH is almost always a Japan distributor, import agent, or a Japan entity established specifically for this purpose. The commercial arrangement with that entity is a separate matter from the IOR customs structure.
How the IOR Structure Works for Medical Devices
The IOR and ACP structures address the customs-layer problem: who is legally named as importer on Japan's import declaration. For medical device imports, the choice of structure depends on the commercial model and the distribution arrangement already in place for the PMD Act layer.
Structure A: Aplash as IOR (Buy-and-Sell)
Under this structure, Aplash is the legal importer of record. Aplash purchases the medical devices from the overseas manufacturer, clears customs in Aplash's name, pays import duties and Japanese Consumption Tax (JCT / 消費税), and re-sells the goods to the Japan-based MAH-licensed distributor or entity. Aplash issues a qualified invoice (適格請求書) under the Qualified Invoice System (インボイス制度), enabling the Japan buyer to claim JCT input credit on the re-sale transaction.
This structure is appropriate when the overseas manufacturer does not wish to appear on Japanese customs documents, has no Japan entity, and the downstream Japan distributor (who holds or is seeking the MAH licence) is the natural commercial buyer. It is the most common structure for Class I and Class II device imports where the MAH is a Japan company commercially distinct from the foreign manufacturer.
The buy-and-sell nature of the IOR engagement is substantive, not nominal. Aplash holds genuine title to the goods between purchase and re-sale, bears import-refusal risk during clearance, and files its own import declaration. A name-lending arrangement where Aplash appears on customs documents without commercial substance would constitute a false customs declaration under the Customs Act (関税法) and is not permitted.
Structure B: Manufacturer as IOR via Attorney for Customs Procedures (税関事務管理人)
Under this structure, the overseas manufacturer is named as the legal importer on the import declaration. Aplash acts as the Attorney for Customs Procedures (税関事務管理人) under Article 95 of the Customs Act (関税法), serving as the manufacturer's procedural representative before Japan Customs. The attorney appointment is required because the manufacturer has no Japan address or resident presence.
This structure additionally requires:
(a) Registration of the overseas manufacturer under Japan's Qualified Invoice System (インボイス制度) as a Qualified Invoice Issuer (適格請求書発行事業者).
(b) Appointment of a Tax Representative (納税管理人) to handle consumption tax obligations in Japan on the manufacturer's behalf.
Without both registrations in place before the first shipment, the manufacturer cannot lawfully be the declared importer and recover JCT as a non-resident entity.
The IOR and ACP structures are legally distinct. They are not alternatives where one is chosen based on cost. The choice follows from who must appear as importer under the commercial and regulatory arrangement. Both structures can coexist in a medtech company's Japan import programme if different product lines or distribution channels warrant different approaches.
The MAH Question and IOR: Two Separate Approvals from Two Separate Agencies
A question that arises frequently in medtech market entry: can the overseas manufacturer serve as both the IOR and the MAH?
The IOR appointment and the MAH licensing are separate matters governed by separate agencies, with no direct linkage between them.
The IOR structure, whether buy-and-sell through Aplash or ACP-based with Aplash as attorney, is a customs matter under the Customs Act (関税法) administered by Japan Customs under the Ministry of Finance (財務省). It determines who is the legal importer on the customs declaration.
The MAH licence is a product regulatory matter under the Pharmaceutical and Medical Device Act (薬機法) administered by MHLW. It determines who is legally responsible for the marketed device in Japan.
A foreign manufacturer can pursue Foreign Manufacturer Accreditation (外国製造業者認定) from MHLW, which registers the manufacturing facility and is required for the Japan MAH to hold approval for devices manufactured at that site. But this accreditation does not give the foreign manufacturer MAH status without a Japan-licensed entity in the chain.
The practical implication: a medtech company that appoints Aplash as IOR for customs clearance still needs a Japan MAH. The IOR appointment handles the import declaration. The MAH handles the product approval and market responsibility. Both must be in place for regulated device classes before commercial shipments proceed.
HS Classification for Medical Devices
Medical devices and healthcare equipment are predominantly classified under Chapter 90 of Japan's tariff schedule, covering optical, measuring, and medical instruments. The specific heading depends on the nature and function of the device.
Common Chapter 90 headings for medical devices include:
- Heading 9018: instruments and appliances for medical, surgical, dental, or veterinary use, including diagnostic imaging apparatus and other electro-medical apparatus
- Heading 9019: mechanotherapy appliances and massage apparatus
- Heading 9021: orthopaedic appliances, artificial body parts, and hearing aids
Some healthcare equipment with primarily electronic components may be classified under Chapter 85 depending on the primary function and how General Rules of Interpretation apply.
Why classification matters. The HS heading determines the applicable duty rate, which affects landed cost calculations and the IOR's pass-through cost to the Japan buyer. Misclassification creates exposure: underpayment or overpayment of customs duty, and potential inconsistency with any MHLW product descriptions, which can create regulatory friction at clearance.
Advance ruling (事前教示) for medical devices. For novel or combination devices where Chapter 90 classification is not straightforward, a binding advance ruling from Japan Customs before the first shipment removes classification uncertainty. The advance ruling, available under the Customs Act (関税法), binds Japan Customs to the classified heading for the submitted device description and is reusable across subsequent shipments of the same product.
Which IOR Structure Fits Which Medtech Commercial Model
(a) B2B selling to a Japan hospital or distributor where the Japan distributor holds the MAH licence. This is the most common model for Class I and Class II device imports. Aplash as IOR (Structure A, buy-and-sell) fits cleanly: Aplash buys from the overseas manufacturer, clears customs, and re-sells to the Japan distributor. The distributor's MAH position is unaffected by the customs import structure.
(b) Direct importing for a manufacturer's own Japan entity. A manufacturer that has established its own Japan subsidiary (KK or GK) may have that subsidiary as the natural MAH and the natural Japan buyer. In this case, the manufacturer's own Japan entity should typically appear as the importer on the customs declaration, removing the need for Aplash IOR or ACP once the entity is operational. During the entity formation and initial customs registration period, an ACP appointment (Structure B) with Aplash as attorney can bridge the gap.
(c) Manufacturer remaining as declared importer for direct hospital or end-user supply. Where the commercial model requires the manufacturer to maintain the importer position, for example in a direct-import arrangement with a hospital group, the ACP structure (Structure B) is the appropriate fit. The manufacturer is the declared importer; Aplash acts as procedural attorney. This requires the manufacturer to complete Qualified Invoice System (インボイス制度) registration and Tax Representative (納税管理人) appointment before the first declaration is filed.
(d) Parallel importing. Parallel import of medical devices, where a party imports a device approved in another jurisdiction without the Japan MAH's involvement, is heavily restricted in Japan. For regulated device classes, parallel import without PMD Act clearance constitutes an illegal import of an unregistered medical device under the Pharmaceutical and Medical Device Act (薬機法). The IOR or ACP structure cannot resolve a parallel import situation where the underlying product lacks the required approval.
Common Mistakes in Medical Device Import Compliance
Mistake 1: Assuming IOR solves the product approval problem. An IOR appointment resolves the customs importer question. It does not provide PMD Act clearance. A Class II or higher device imported under an IOR arrangement without the corresponding certification or approval in place is an unregistered medical device under Japanese law, regardless of how cleanly the customs declaration was filed.
Mistake 2: Filing import declarations before PMD Act clearance is in place for regulated device classes. Japan Customs and MHLW share information on regulated product imports. For Class II and higher devices, customs clearance without the corresponding PMD Act clearance does not create legal marketability. The goods may clear customs but cannot be sold or distributed in Japan until the regulatory approval is in place.
Mistake 3: Not completing Qualified Invoice System registration before the first shipment under the ACP structure. Under Structure B, the manufacturer must be registered as a Qualified Invoice Issuer before the first import declaration is filed. Registration cannot be backdated. A shipment filed before registration is complete means the manufacturer cannot recover import JCT through the qualified invoice mechanism for that shipment.
Mistake 4: Treating the MAH relationship as a customs matter. The choice of MAH and the contractual terms of the MAH licensing or distribution agreement are governed by the PMD Act and commercial contract law. The IOR or ACP customs structure does not determine, create, or affect the MAH relationship.
Mistake 5: Assuming a Class III or IV device can proceed on the same timeline as a Class I or II device. The PMD Act regulatory pathway for Class III and IV devices involves PMDA technical review and MHLW ministerial approval. The timeline is measured in years, not months.
Setup Timeline: What Runs in Parallel and What Cannot
Medical device market entry in Japan has a hard sequencing constraint: the product regulatory approval under the PMD Act is typically the longest lead-time item, and commercial distribution cannot begin until that approval is in place for regulated device classes. The customs structure work, however, can and should proceed in parallel.
The following elements can be initiated simultaneously:
ACP or IOR onboarding with Aplash, including KYC, contract execution, and (for the ACP structure) initiation of Qualified Invoice System registration and Tax Representative appointment, typically requires two to four weeks to complete. This work is independent of the PMD Act pathway and should begin as soon as the commercial and distribution structure is decided.
HS classification review and, where appropriate, advance ruling preparation for the specific device models can proceed immediately. This does not require the PMD Act approval to be in place.
PMD Act pathway planning, including device class assessment, selection and engagement of a Japan MAH-licensed distributor or entity, Foreign Manufacturer Accreditation application, and preparation of technical documentation for the certification or approval submission, can all begin immediately.
The following element cannot begin until the PMD Act clearance is in place: commercial shipments of regulated device classes to Japan buyers for onward sale or distribution. The import declaration can be filed once the IOR or ACP structure is in place and the goods are ready to ship, but the commercial distribution chain beyond the first Japan-side entity cannot activate until the required approval or certification is secured.
For Class II devices, a realistic timeline from initial regulatory planning to first commercial shipment is twelve to twenty-four months, dominated by the certification timeline. For Class III and IV devices, the timeline is longer and governed by PMDA review scheduling. Class I devices, requiring only a prefectural notification, can move considerably faster.
This article is informational only and does not constitute legal, regulatory, or customs advice. Medical device import compliance in Japan is subject to product-specific requirements under both the Pharmaceutical and Medical Device Act (薬機法) and the Customs Act (関税法). Consult a qualified regulatory affairs specialist, licensed customs specialist (通関士), or attorney (弁護士) with Japan import experience before acting on this content. Last updated: June 2026.