Medical-device imports into Japan are governed by 薬機法 (Pharmaceutical and Medical Device Act), which classifies devices into Class I through Class IV. Aplash acts as named Importer of Record for Class I and Class II devices and coordinates with a partner 製造販売業者 (MAH, Marketing Authorization Holder). Class III and Class IV engagements are restricted scope and require pre-engagement assessment before quoting.
Request Assessment| Class | Description | Aplash position |
|---|---|---|
| Class I (一般医療機器) | General medical device, low risk | Handle — 輸入届 coordination |
| Class II (管理医療機器) | Controlled medical device | Handle — 認証 coordination via Registered Certification Body |
| Class III (高度管理医療機器) | Highly controlled device | Restricted — pre-engagement assessment |
| Class IV | Highly invasive device | Restricted — pre-engagement assessment |
The 製造販売業者 (MAH) is the compliance principal: it owns post-market surveillance, pharmacovigilance, and product-safety obligations. The Importer of Record is the customs principal: it files the import declaration and assumes 関税法 (Customs Act) liability. Aplash acts as IOR and coordinates with a separately licensed partner MAH.
| Class | Path | Authority |
|---|---|---|
| I | 届出 (notification) | Regional Bureau of Health and Welfare |
| II | 認証 (certification) | Registered Certification Body |
| III | 承認 (approval) | PMDA |
| IV | 承認 (approval) | PMDA |
The 薬監証明 (yakkan-shomei) is a customs-clearance certificate for restricted imports such as samples, R&D quantities, and clinical-trial materials. It exempts the specific shipment from full MAH-route compliance and is the standard path for evidence-gathering shipments before commercial launch.
Class I: from $4,800 per shipment + import-notification coordination. Class II: from $7,500 per shipment + 認証 (Ninsho) coordination. Class III and IV: quoted after pre-engagement assessment; floor undisclosed publicly.
Customs duties and Japanese consumption tax (JCT) pass through at cost. Aplash earns no margin on the goods, only on the service.
For Class I through IV devices intended for sale or distribution in Japan, a 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 薬監証明 (yakkan-shomei) exemption path.
No. The 製造販売業者 function requires its own 業許可 (business permit) and pharmacovigilance infrastructure. Aplash coordinates with partner MAHs and acts separately as Importer of Record.
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 the specific shipment from full MAH-route compliance.
In vitro diagnostic reagents are regulated under 薬機法 (Pharmaceutical and Medical Device Act) with a separate subclassification. Aplash coordinates IVD import via the relevant pathway and confirms classification before customs filing.
PMDA (Pharmaceuticals and Medical Devices Agency) approval for Class III devices typically takes 12 to 24 months from full submission, depending on novelty and clinical data. Aplash coordinates only via partner MAH; the approval pace rests with PMDA.
Engagement starts with a free device-classification review. We confirm 薬機法 (Pharmaceutical and Medical Device Act) classification, marketing-authorisation path, and IOR feasibility before quoting.
Request a no-cost commodity assessment. We confirm IOR feasibility and quote against the public pricing band before any commitment.
Request Assessment