Cosmetics, quasi-drugs & medical devices × Foreign seller — no entity in Japan (own-name import via ACP)

Rules verified as of 2026-08-08 · reviewed quarterly (next review: November 2026)

Typical products: Skincare, makeup, medicated creams, contact lenses, massage devices

This is the license-wall category: without a licensed Japanese MAH you cannot market these products, full stop. Plan the partnership first.

Which regimes apply

PMD Act — cosmetics, quasi-drugs, medical devices (薬機法)

Cosmetics, quasi-drugs and medical devices can only be marketed by a LICENSED marketing authorization holder in Japan (化粧品製造販売業許可 etc.). This is a license wall: an ACP does not substitute for it. Foreign brands appoint a licensed Japanese MAH (or use the foreign-manufacturer registration + designated MAH scheme).

Engage a licensed Japanese marketing authorization holder (MAH)
Product notifications / approvals as required per category
Japanese labeling under the MAH's name before sale

Sources: MHLW — pharmaceuticals & medical devices · PMDA (English)

Customs: duty, consumption tax and the importer of record

Every commercial import needs an importer of record with post-release disposal authority, correct HS classification, duty and 10% consumption tax. A non-resident importer files through an Attorney for Customs Procedures (ACP, 税関事務管理人) and needs a tax agent for JCT recovery.

Classify the product (HS code) and check the duty rate
Convert values with the official customs FX rate
Non-residents: appoint ACP (form C-7500) before the first declaration

Sources: Customs Answer 9601 — ACP

→ Tools: tariff finder & landed-cost calculator · customs FX rates · Guides: IOR, ACP

Who can be the importer — verdict

You CAN be the importer of record as a non-resident by appointing an Attorney for Customs Procedures (ACP) before the first declaration, and a tax agent to recover import JCT. BUT product regimes that require a domestic notifier or license holder (PSE, PSC, food sanitation, PMD) are NOT satisfied by the ACP — you need a Japan-side responsible business for those: a partner importer, or (for direct B2C sales of PSE/PSC goods since Dec 2025) a notified 国内管理人.

Your checklist

Appoint an ACP (税関事務管理人) — Customs form C-7500 — before the first import declaration
Appoint a tax agent (納税管理人) with the tax office if you will recover import JCT
Confirm who fulfils each product regime on the Japanese side (see the regimes above)
Register the invoice/classification pack: HS code, duty rate, customs FX rate
[PMD Act] Engage a licensed Japanese marketing authorization holder (MAH)
[PMD Act] Product notifications / approvals as required per category
[PMD Act] Japanese labeling under the MAH's name before sale
[Customs: duty, consumption tax and the importer of record] Classify the product (HS code) and check the duty rate
[Customs: duty, consumption tax and the importer of record] Convert values with the official customs FX rate
[Customs: duty, consumption tax and the importer of record] Non-residents: appoint ACP (form C-7500) before the first declaration