Yes. An IOR (importer of record) or ACP (Attorney for Customs Procedures) appointment only satisfies the customs side of bringing cosmetics into Japan. Separately, under the Pharmaceutical and Medical Device Act (薬機法), whoever places the cosmetics on the Japan market must hold its own marketing licence under that Act, and the overseas factory that makes them must be registered as a foreign manufacturer before the first legal sale.
What Does an IOR or ACP Appointment Actually Cover for Cosmetics?#
It answers one question only: who is the customs importer of record for the shipment. An IOR structure has Aplash or another Japan entity buy and resell the goods so the cargo clears customs under a Japan party's name. An ACP appointment under the Customs Act (関税法) lets a non-resident act as its own importer while a Japan-based attorney handles the customs declaration and duty payment on its behalf. IOR vs ACP for Japan Imports sets out that choice in full, and the distinction matters here because neither structure, on its own, says anything about who may sell the product once it has cleared the port.
Customs clearance and market authorization are checked by different authorities at different points in the supply chain. Customs confirms the declared value, HS classification, and duty are correct at the border. The Ministry of Health, Labour and Welfare (MHLW, 厚生労働省) checks, separately, whether the product and the party selling it are licensed to be on the Japan market at all. A shipment can clear customs cleanly through a well-structured ACP appointment and still be illegal to sell the day it lands, if the market-side licence is missing.
What Licence Does the Pharmaceutical and Medical Device Act Require for Cosmetics?#
Cosmetics in Japan fall under the Pharmaceutical and Medical Device Act (薬機法), the same statute that governs medical devices and quasi-drugs. The Act requires the party that places a cosmetic product on the Japan market to hold a licence under that Act, distinct from any customs role the same company, or a different company, might hold. This is a market-entry gate, not a border formality, and it sits upstream of the first retail sale rather than downstream of customs clearance.
The same governing statute runs through adjacent product categories as well. Importing Medical Devices to Japan covers how the Act's PMDA registration layer works for devices, and the cosmetics licensing requirement follows the same logic even though the specific category and review process differ from medical devices.
Who Has to Hold the Japan-Side Marketing Licence?#
The party that places the cosmetics on the Japan market holds the licence, and that party is defined by its market role under the Act, not by its customs role. A brand that has arranged IOR or ACP for customs purposes has solved who clears the goods through the port. It has not automatically solved who is licensed to sell them, because the Act treats the marketing-licence holder as a distinct legal role from the customs importer of record.
In practice this means a foreign cosmetics brand needs two separate questions answered before its first shipment: who clears customs, and who holds the Japan-side licence to market the product once it has cleared. The same entity can sometimes fill both roles, but holding one does not create the other. Japan IOR for Medical Devices and Healthcare Equipment describes a parallel situation in the device category, where the import structure and the market authorization are built and tracked as separate workstreams from the start.
What Is Foreign Manufacturer Registration, and Why Does the Factory Need It?#
Foreign manufacturer registration is a separate requirement that attaches to the overseas factory itself, not to the Japan-side importer or the Japan-side licence holder. The Pharmaceutical and Medical Device Act requires the facility that manufactures the cosmetics to be registered with the Japanese authorities before its products can lawfully be sold in Japan. Without that registration, the Japan-side marketing licence has nothing valid underneath it, because the product is traceable back to a manufacturing site the Act does not yet recognize.
This registration has to be in place before the first shipment can be legally sold in Japan, not arranged afterward as a formality. A brand that lines up its IOR or ACP customs structure and its factory's manufacturing schedule without checking foreign manufacturer registration can end up with inventory sitting in Japan that it is not yet permitted to sell.
Can a Brand Use an ACP Appointment and Skip the Japan-Side Licence?#
No. An ACP appointment under the Customs Act lets a non-resident clear customs through a Japan-based attorney, and it does nothing to satisfy the Pharmaceutical and Medical Device Act's requirement that the market-placing party hold its own licence. The two requirements run on different statutes, are administered by different authorities, and are checked at different points: Customs at the border, MHLW before and during retail sale.
A brand that treats ACP as a complete Japan market-entry package for cosmetics has confused the customs layer with the regulatory layer. The ACP appointment is still useful and often necessary, since someone has to clear the shipment through customs regardless of how the licensing question is resolved. It is simply not the same decision as who holds the marketing licence or whether the factory is registered.
Three facts anchor the decision a cosmetics brand actually has to make before its first shipment.
(a) The Pharmaceutical and Medical Device Act (薬機法), administered by MHLW, requires a Japan-side marketing licence held by the party placing the cosmetics on the market, separate from the customs importer of record. (b) The overseas manufacturing facility must be registered as a foreign manufacturer under the same Act before its cosmetics can be lawfully sold in Japan, and this registration has to be completed before the first shipment moves into retail, not after. (c) An IOR or ACP structure satisfies the customs clearance requirement only; it does not substitute for either the marketing licence or the foreign manufacturer registration, and a brand holding only a customs structure is not yet market-compliant.
Frequently Asked Questions#
If our ACP is already in place, do we still need a separate cosmetics licence before we can sell?
The ACP appointment covers customs clearance under the Customs Act only and says nothing about market authorization under the Pharmaceutical and Medical Device Act. The marketing licence and the foreign manufacturer registration are both separate requirements that have to be satisfied before the product can be legally sold in Japan, regardless of how cleanly it clears customs.
Does the factory need its own registration even if our Japan-side licence is already approved?
It does, because foreign manufacturer registration attaches to the manufacturing site itself, and a Japan-side marketing licence does not substitute for it. A cosmetics product manufactured at an unregistered facility has nothing valid underneath an otherwise approved Japan-side licence, so both pieces need to be in place together.
Can the same company hold the customs role and the Japan-side marketing licence?
It can, but holding one does not create the other automatically. The customs importer of record role under IOR or ACP and the marketing-licence holder role under the Pharmaceutical and Medical Device Act are legally distinct, so each has to be established and confirmed on its own, even when the same company intends to fill both.
This article is informational only and does not constitute legal, tax, or regulatory advice. Consult a qualified advisor before acting on the content. Last updated: October 2026.