Medical Device Importer of Record in Japan (薬機法 Class I to IV)
Want to sell a medical device in Japan but have no entity there to import it? Aplash becomes your Importer of Record (IOR) for Class I and Class II devices: the legal company named on the customs entry. We file under the Customs Act (関税法) and coordinate with a partner Marketing Authorization Holder (製造販売業者, MAH), the separate company responsible for the device's regulatory compliance. Imports are governed by the Pharmaceutical and Medical Device Act (薬機法), which sorts devices into Class I through Class IV. Class III and Class IV are restricted scope and need a pre-engagement assessment before we can quote.
How it works
An Importer of Record (IOR) is the company legally responsible for bringing goods through customs. Aplash takes that role so you can sell into Japan without a local entity.
- 1Free commodity assessmentSend your product details. We confirm whether Aplash can be your importer and give you a quote, at no cost.
- 2We import as your Importer of RecordAplash clears customs in its own name under the Customs Act (関税法) and arranges any permits or certifications your goods need.
- 3Delivered to your Japan buyerWe hand the goods to your Japan-side buyer and invoice transparently, so you sell in Japan with no company of your own there.
What Aplash handles
- Act as named Importer of Record for Class I (一般医療機器, General Medical Device) and Class II (管理医療機器, Controlled Medical Device).
- Coordinate with a partner Marketing Authorization Holder (製造販売業者, MAH). Aplash introduces or coordinates with the MAH; we do not act as MAH ourselves.
- Coordinate the import notification (輸入届) for Class I.
- Coordinate certification (認証, Ninsho), the pre-market check for Class II, through an accredited Registered Certification Body (登録認証機関).
- Coordinate sample, personal-use, and clinical-trial exemption imports via the customs clearance certificate (薬監証明, yakkan-shomei) for restricted shipments.
- Handle In Vitro Diagnostic (IVD) reagent imports with the correct subclass classification.
What we do not handle
- Class III and Class IV devices. Restricted scope; pre-engagement assessment required.
- Act as the Marketing Authorization Holder (製造販売業者, MAH). This requires its own business permit (業許可). Aplash coordinates with a partner MAH instead.
- Handle pre-market approval (承認, Shonin) for Class III and Class IV. This review sits with the Pharmaceuticals and Medical Devices Agency (PMDA).
- Sponsor clinical trials. Out of scope.
- Pharmaceuticals (drugs). Different framework; Aplash does not currently offer pharma IOR services.
Class explainer and Aplash service level
| Class | Description | Aplash position |
|---|---|---|
| Class I (一般医療機器) | General medical device, low risk | We handle it: import notification (輸入届) coordination |
| Class II (管理医療機器) | Controlled medical device | We handle it: certification (認証) coordination via Registered Certification Body |
| Class III (高度管理医療機器) | Highly controlled device | Restricted scope: pre-engagement assessment required |
| Class IV | Highly invasive device | Restricted scope: pre-engagement assessment required |
MAH vs IOR: two different jobs
It is easy to confuse these two roles, so here is the plain distinction. The Marketing Authorization Holder (製造販売業者, MAH) is the compliance principal: it owns post-market surveillance, pharmacovigilance, and product-safety obligations for the device's life in Japan. The Importer of Record is the customs principal: it files the import declaration and takes on liability under the Customs Act (関税法). Aplash acts as IOR and coordinates with a separately licensed partner MAH, so you get both functions covered without setting up a Japanese entity yourself.
Pre-market path matrix
| Class | Path | Authority |
|---|---|---|
| I | Notification (届出) | Regional Bureau of Health and Welfare |
| II | Certification (認証) | Registered Certification Body |
| III | Approval (承認) | PMDA |
| IV | Approval (承認) | PMDA |
Sample and clinical exemption (薬監証明, yakkan-shomei)
Need to bring in samples, R&D quantities, or clinical-trial materials before you launch commercially? The yakkan-shomei (薬監証明) is a customs-clearance certificate that covers exactly that. It exempts that specific shipment from the full MAH compliance route, making it the standard path for evidence-gathering shipments ahead of commercial launch.
Pricing band
Class I: from $4,800 per shipment, plus import-notification coordination. Class II: from $7,500 per shipment, plus certification (認証, Ninsho) coordination. Class III and IV: quoted after pre-engagement assessment; floor undisclosed publicly.
Customs duty and Japanese consumption tax (JCT) are passed on at cost. Aplash earns no margin on the goods, only on the service.
Not sure if your goods qualify?
Send the product details. We confirm whether Aplash can import it and quote against the public pricing band before you commit.
Frequently asked questions
Do I need a MAH (製造販売業者) to import my device into Japan?
For Class I through IV devices intended for sale or distribution in Japan, a Marketing Authorization Holder (製造販売業者, MAH) is the compliance principal. Aplash coordinates with a partner MAH; we are not the MAH ourselves. Sample, R&D, and clinical-trial imports may use the yakkan-shomei (薬監証明) exemption path instead.
Can Aplash be my MAH?
No. The Marketing Authorization Holder (製造販売業者) function requires its own business permit (業許可) and pharmacovigilance infrastructure. Aplash coordinates with partner MAHs and acts separately as Importer of Record.
What is yakkan-shomei (薬監証明)?
The yakkan-shomei is a customs-clearance certificate issued by a regional Bureau of Health and Welfare for restricted imports such as samples, R&D quantities, and clinical-trial materials. It exempts that specific shipment from the full MAH compliance route.
Are IVD reagents medical devices in Japan?
Yes. In vitro diagnostic reagents are regulated under the Pharmaceutical and Medical Device Act (薬機法) with their own subclassification. Aplash coordinates IVD imports through the relevant pathway and confirms classification before filing with customs.
How long does Class III approval take?
Approval (承認) for Class III devices from the Pharmaceuticals and Medical Devices Agency (PMDA) typically takes 12 to 24 months from full submission, depending on novelty and clinical data. Aplash coordinates only via the partner MAH; the approval pace rests with PMDA.
Applicable law and standards
- Customs Act (関税法)
- Pharmaceutical and Medical Device Act (薬機法)
Related pages
Engagement starts with a free device-classification review. We confirm your classification under the Pharmaceutical and Medical Device Act (薬機法), map out the marketing-authorisation path, and check IOR feasibility before quoting.