Cosmetics, quasi-drugs & medical devices × Individual — personal use

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

Personal-use imports are outside most business notification regimes (PSE/PSC notifications target businesses; food notification is not needed for small personal quantities; cosmetics have quantity allowances). Radio devices are the exception in practice: using a non-certified transmitter is still a Radio Act violation. Customs duty/JCT apply above the exemptions, with the ¥10,000 de minimis.

Your checklist

Stay within personal-use quantities (resale voids the exemptions)
Radio devices: check 技適 certification before buying
Expect duty/JCT above ¥10,000 customs value
[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