Cosmetics & Personal Care Products Import to Japan Guide

01

Beauty, Oral Care & Legal Product Class

Which Cosmetics and Personal Care Products Can Be Imported into Japan?

Start with the product category, the claims and the Japanese buyer. Toothpaste, shampoo or "medicated" skincare may require different procedures even when sold through the same beauty retail channel.

Personal care is a commercial category, not a Japanese legal category. Japan's Pharmaceuticals and Medical Devices Act (PMD Act / 薬機法) may regulate the finished product as an ordinary cosmetic ( keshohin ), a quasi-drug ( iyaku bugaihin ) or a different product type. Product purpose, formula, active ingredients and claims determine the route.

Skincare & makeup

Serums, facial moisturisers, cleansers, face masks, foundations and lip products are often ordinary cosmetics.

Haircare & body care

Shampoos, conditioners, body wash, lotions, soaps, fragrance and some bath products can be ordinary cosmetics or quasi-drugs.

Toothpaste & oral care

Basic toothpaste can be a cosmetic, while many fluoride-containing or medicated toothpastes are quasi-drugs in Japan.

Medicated & specialist products

Medicated skincare, hair dyes, antiperspirants, some hair-growth products and other specialist products need closer classification.

Common products and possible Japanese classifications

Product family	Ordinary cosmetic examples	Possible quasi-drug / other examples	What changes the route
Skincare & makeup	Moisturisers, cleansers, lipstick, foundation and many serums.	Some medicated skin preparations or products with specific therapeutic claims.	Formulation, purpose and Japanese marketing claims.
Shampoo & haircare	Ordinary shampoos, conditioners and hair styling products.	Certain medicated shampoos, hair-growth products, hair dyes and permanent-wave preparations.	Medicinal active ingredients and regulated product purpose.
Toothpaste & oral care	Basic tooth-cleaning pastes without medicinal active ingredients.	Many fluoride or other medicated toothpastes.	Medicated ingredients and claimed effects. Toothpaste is not one uniform legal class.
Body care & hygiene	Body lotions, normal body cleansers and some soaps.	Some medicated soaps, antiperspirants, deodorants or bath preparations.	Specific product ingredients, intended use and claims.
Fragrance, nail & beauty	Perfumes, nail cosmetics and certain cosmetic sun-protection products.	Some products using medicinal or other regulated claims may need a different route.	Separate freight safety checks may apply for flammable liquids or aerosols.
Other personal care goods	Toothbrushes, grooming accessories and other items may sit outside the cosmetics/quasi-drug framework.	A separate law, such as medical-device or consumer-product rules, may apply to certain products.	The commercial term "personal care" does not define the Japanese legal classification.

What to confirm before setting up the import

First check	Why it matters	Usually supplied by
Product name, purpose and claims	Identifies the likely legal category and whether the proposed claims are allowed in Japan.	Overseas manufacturer / brand
Full ingredients and active ingredients	Allows a licensed Japanese party to review standards, restrictions and potential quasi-drug approval.	Manufacturer; reviewed by Japanese licensed party
Origin, manufacturing sites and label artwork	Supports the applicable foreign manufacturer procedures and Japanese statutory labelling.	Overseas manufacturer
Japanese buyer and expected sales	Shows the actual commercial demand and helps determine a workable Japan-side supply arrangement.	Brand and Japanese salon / distributor / retailer
Trial and recurring order size	Connects regulatory setup effort with a realistic air/ocean freight and replenishment plan.	Brand and Japanese buyer

You have a buyer in Japan, but they do not have a licence?

A Japanese salon or retailer can generally resell lawfully marketed and released cosmetics or quasi-drugs without itself holding a manufacturing-and-marketing licence. The Japanese licensed responsible party and correct import arrangement are separate matters, assessed per product.

02

Product Evidence, Licences & Trade Papers

What Documents Are Needed for Cosmetics and Personal Care Imports?

The document list changes when a product is classified as a quasi-drug rather than an ordinary cosmetic. Review the two tracks before shipping.

Documents serve different purposes: product classification and approval , Japanese licensed-party responsibility, shipping and Customs clearance, and lawful market release. Not every document applies to every product. The licensed Japanese party identifies its filings; the appointed broker confirms the Customs entry evidence.

Document / Information	Main Purpose	Prepared or Issued By	Product Examples / When Required
Product catalogue, intended use & claims / Product brief	Initial Japanese cosmetics / quasi-drug / other-product classification.	Overseas manufacturer / brand	Each product or range, before agreeing a filing route.
Full ingredient list / formulation / Formula information	Check Japanese ingredients and active substances against the rules for the product class.	Overseas manufacturer; licensed Japanese party reviews	All regulated products; detailed formula may be supplied confidentially to the licensed party.
Quasi-drug product approval dossier / 医薬部外品製造販売承認申請資料	Support product-specific assessment of the formulation, effectiveness, safety, specifications and manufacturing particulars.	Manufacturer and relevant Japanese quasi-drug MAH	Quasi-drugs requiring marketing approval; not a standard cosmetic E83 filing.
Product specification / quality standard / 製品規格	Define identity, quality limits and batch-acceptance information.	Manufacturer; Japanese MAH reviews	Relevant products; degree of technical evidence varies.
Manufacturing sites & foreign company information / 海外製造所情報	Identify actual producing / marketing sites for the appropriate foreign notification or accreditation route.	Manufacturer; Japanese MAH handles filings	For imported finished regulated products.
Manufacturing records / CoA / batch information / 製造記録・試験成績書	Help the licensed party assess lot quality and record controlled release.	Overseas manufacturer / laboratory	Requested according to the product class and licensed party quality system.
Japanese label artwork and claim review / 日本語表示案	Check product name, responsible company, ingredients, statutory markings and permitted advertising.	Japanese MAH, overseas brand	Before labels / packaging are finalised; different regimes may apply.
Japanese cosmetics MAH licence / 化粋品製造販売業許可	Confirm the responsible party has the correct Japanese business authorisation.	Licensed Japanese cosmetics MAH	Ordinary cosmetics; not newly obtained for each shipment.
Japanese quasi-drug MAH licence / 医薬部外品製造販売業許可	Confirm the Japanese responsible party is licensed for quasi-drug marketing.	Licensed Japanese quasi-drug MAH	Quasi-drug products; a cosmetics-only licence is insufficient.
Foreign cosmetic manufacturer / marketer notification (C73) / 化粋品外国製造販売（製造）業者届	Notify the relevant foreign party to Japanese authorities via PMDA.	Licensed Japanese cosmetics MAH	Applicable imported ordinary cosmetics; not the quasi-drug foreign accreditation route.
Cosmetic product marketing notification (E83) / 化粋品製造販売届	File the product before marketing through the competent prefectural authority.	Licensed Japanese cosmetics MAH	Ordinary cosmetics, generally per product rather than per import lot.
Quasi-drug product marketing approval / 医薬部外品製造販売承認	Establish the product-specific authorised quasi-drug basis before commercial marketing.	Japanese quasi-drug MAH; MHLW or delegated prefectural authority approves	Generally required for quasi-drugs, subject to applicable statutory exceptions.
Foreign quasi-drug manufacturer accreditation / 外国製造業者認定	Confirm required accreditation of the relevant overseas quasi-drug manufacturing site.	Foreign manufacturer with Japanese regulatory coordination / PMDA process	Quasi-drugs where required; distinct from cosmetic C73 notification.
Domestic manufacturing / packaging / storage licence evidence / 製造業許可関係資料	Verify that applicable Japanese regulated manufacturing activities have a licensed arrangement.	Responsible Japanese MAH / relevant licensed site	Depends on actual operations and category; details confirmed by licensed party.
Commercial Invoice / インボイス	Support actual transaction, customs valuation, seller, buyer, quantity and terms.	Overseas seller / exporter	Every commercial import; must match real commercial arrangements.
Packing List / パッキングリスト	Identify cartons, weights, dimensions, product types and lot numbers where available.	Overseas shipper	Each shipment.
Bill of Lading / Air Waybill / B/L or AWB	Identify transport shipment and control arrival / cargo-release paperwork.	Carrier / logistics provider	Ocean or air shipment, as applicable.
Purchase order / sales contract / 発注書・売買契約書	Confirm the real trade structure and buyer / seller when the importer differs from the MAH.	Overseas seller / Japanese buyer	As needed to substantiate the actual Customs importer.
Customs declaration and import permission / 輸入申告・輸入許可	Complete Japanese import clearance subject to the relevant PMD Act checks.	Appointed licensed Customs broker; Japan Customs	Each Customs import entry.
Quality and market-release records / 市場出荷判定記録	Document required controls and release decisions for regulated products.	Responsible Japanese MAH	As required by product class and its quality system.
SDS / dangerous-goods data / 安全データシート	Assess alcohol-rich perfumes, aerosols, flammable liquids and transport restrictions.	Overseas manufacturer / shipper	When product or package creates possible DG transport restrictions.
Preferential-origin supporting evidence / 原産地関係資料	Support a preferential duty claim if applicable and origin rules are satisfied.	Exporter / relevant certifying party	Only when tariff preference is claimed.

Do not confuse a licence, a notification and a product approval

A manufacturing-and-marketing business licence belongs to the responsible Japanese company. Ordinary cosmetics generally require product notification ; quasi-drugs generally require product marketing approval . None of these replaces the Customs import permission for the actual shipment.

03

Responsibility Split & Buyer Relationship

Who Handles the Import When the Japanese Buyer Has No Product Licence?

An overseas brand may already have demand in Japan but no regulatory import arrangement. Clarify the buyer, the licensed Japanese party and the logistics provider before booking.

Your Japanese buyer and your Japanese regulatory responsible party can be different companies. For example, a beauty salon or distributor may buy and resell products lawfully released by a Japanese MAH, even if that salon does not hold its own cosmetics or quasi-drug manufacturing-and-marketing licence.

Party	Main Role	Accountability / Handover
Overseas manufacturer / brand	Supplies accurate formula / active ingredient data, product claims, site details, batch records, transport information and export paperwork.	Agrees commercial sale terms and makes technical information available for the Japanese review.
Japanese buyer / salon / retailer	Confirms purchase interest, quantity, sales channels and the expected replenishment plan. Resells goods after lawful market supply.	May be a downstream reseller without an MAH licence; cannot independently place unapproved or unreleased products on the Japanese market.
Licensed Japanese marketing authorisation holder (MAH) Cosmetics MAH or quasi-drug MAH, as appropriate	Reviews the category and product, holds the correct licence, undertakes applicable notifications or approval work, labelling, quality / safety systems and market-release decisions.	The Japanese regulatory responsibility must match the product type. A cosmetics-only MAH is not automatically authorised for quasi-drugs.
Licensed Japanese manufacturing / handling site	Performs regulated Japanese manufacturing / packaging / labelling / storage activities when applicable under the appointed scheme.	May be the MAH's own facility or an authorised operator; the licensed party determines the regulated arrangements.
Gemslinks	Assesses transport feasibility, discusses suitable Japan-side coordination, and arranges agreed international shipping, Customs brokerage and domestic transport.	Logistics and coordination, not an MAH, product approval authority or laboratory.
Appointed licensed Customs broker	Confirms true Customs importer, prepares and files entry, checks PMD Act documents and follows import permission.	Operates under the correct import / declaration authority; special multi-party cases require early confirmation.
Japanese authorities / PMDA / Customs	Handle MAH licences, product filings or marketing approvals, foreign-manufacturer procedures and import clearance.	Regulatory approvals / clearance are authority decisions, never guaranteed by Gemslinks.

Which licence does the Japanese partner need?

If the products are ordinary cosmetics , the responsible Japanese party needs the relevant cosmetics authorisation. For quasi-drugs , a quasi-drug manufacturing-and-marketing authorisation and the applicable product approval process are generally required. A referral or business introduction does not substitute for licensing or product acceptance.

04

First Order to Regular Replenishment

How Does an Overseas Personal Care Brand Supply Buyers in Japan?

Follow the same commercial workflow, but allow for a longer regulatory lead time when a product requires quasi-drug approval.

01

Buyer and product range confirmed

Overseas supplier confirms the Japanese buyer, sales intention, product list, first order and expected repeat shipments.

02

Japanese product classification

The prospective licensed party reviews formula, claims and whether cosmetics, quasi-drug approval or other rules apply.

03

Regulatory readiness and Japanese labels

The licensed party completes the applicable notifications or obtains the necessary approval and confirms Japanese label / claim content.

04

Freight and Customs plan agreed

Gemslinks and the broker arrange shipment, declaration framework, carrier acceptance and required documents with the actual parties.

05

Arrival, Customs and regulated release

The broker completes Customs entry; the licensed Japanese MAH separately controls quality and market release.

06

Buyer supply and repeat shipments

Goods are delivered under the agreed compliant process; replenishment quantities, documentation and bookings are standardised.

Main responsible party, documents and completion criteria

Stage / Process	Main Responsible Party	Documents Used or Produced	Completion / Next Step
1. Buyer and product identified	Overseas brand; Japanese buyer	Product list, sales discussion / purchase order, shipment forecast	Buyer and proposed products identified.
2. Classification and responsible party	Appropriate Japanese licensed party	Formula, active ingredients, claims, manufacturer details	Confirm cosmetics, quasi-drug or another route and responsible MAH.
3. Japan regulatory readiness	Licensed Japanese MAH; regulator if approval required	Cosmetics C73 / E83 or quasi-drug approval / foreign accreditation; Japanese labels	Required filing / approval and labelling arrangements completed before commercial supply.
4. Shipping arrangement	Overseas shipper; Gemslinks	Commercial Invoice, Packing List, B/L or AWB, SDS if required	Transport, Customs entry planning and carrier acceptance confirmed.
5. Arrival and Customs permission	Licensed Customs broker; Japan Customs	Entry documents and applicable PMD Act evidence	Customs import permission obtained.
6. Market release and buyer delivery	Licensed Japanese MAH; delivery provider	Lot / quality records, authorised release instruction	Lawfully released products delivered to the Japanese buyer.
7. Next replenishment	Supplier; Japanese buyer; Gemslinks	Repeat order, batch information, updated transport documents	Repeat bookings follow the accepted product and regulatory arrangements.

Quasi-drug approval can be the gating step

Do not book a shipment for Japanese commercial sale on the assumption that a quasi-drug can use the ordinary cosmetics notification route. Any required product approval and relevant foreign-manufacturer procedure must be confirmed first. Customs import permission and regulated market release remain separate milestones.

05

Japan PMD Act, Approvals & Customs Evidence

Which Japanese Licences, Notifications and Approvals Are Needed?

Ordinary cosmetics and quasi-drugs have different legal routes. The Japanese licensed partner must be authorised for the correct product class.

05.1 - Why toothpaste, shampoos and other personal care products need classification

Japanese classification is based on the actual product and what it claims to do , not simply its English product name. A basic toothpaste may be a cosmetic, while a fluoride-containing medicated toothpaste is generally a quasi-drug. The same distinction can affect medicated hair products, deodorants, skin preparations and other personal-care ranges. Medicines and some consumer goods outside the PMD Act require different evaluation.

05.2 - Cosmetics notification vs quasi-drug product approval

Requirement	Ordinary cosmetics (化粋品)	Quasi-drugs (医薬部外品)
Japanese licensed party	Cosmetics manufacturing-and-marketing licence (化粋品製造販売業許可).	Quasi-drug manufacturing-and-marketing licence (医薬部外品製造販売業許可).
Product-by-product formalities	Typically a cosmetic product marketing notification (E83), with product/formula and claims reviewed by the MAH.	Generally product-specific marketing approval; statutory exceptions must be checked by the authorised party.
Foreign manufacturer	Applicable foreign cosmetic manufacturer / marketer notification (C73) via PMDA.	Foreign quasi-drug manufacturing-site accreditation, as applicable.
Japanese labels and claims	Check statutory display, ingredients and permitted cosmetic claims.	Check label and claims against the authorised quasi-drug product particulars and the applicable advertising rules.
Regulatory lead time	Notification and MAH review typically form the initial readiness steps.	Approval review, possible dossier preparation and manufacturer accreditation may materially extend planning.
Release and import entry	Regulated Japanese MAH controls release; Customs entry proceeds with appropriate evidence.	Same separation of Customs entry and MAH release, with required quasi-drug approvals evidenced.

For ordinary cosmetics, the licensed Japanese Marketing Authorisation Holder (MAH) generally uses the C73 foreign-party notification and E83 cosmetic product marketing notification. For quasi-drugs, a different licensed MAH and generally product-specific approval are required. PMDA explains that certain quasi-drug classes, including qualifying medicated toothpastes, may have approval authority delegated to the prefecture; delegation does not mean that product approval is unnecessary.

05.3 - Japanese ingredient review, labels and product claims

The responsible Japanese party reviews the ingredient formula, intended benefits and required product markings. Japanese labels can be prepared or applied before export if the responsible party approves their content and the applicable requirements are met. Overseas packaging and advertising claims should not be translated without checking the permitted Japanese wording.

Cosmetic ingredients

The Japanese Cosmetic Standards regulate prohibited and restricted ingredients and certain classes of colourants, preservatives and UV filters.

Quasi-drug approval scope

A quasi-drug application must be assessed for product-specific formulation, efficacy / safety, manufacturing particulars and authorised claims.

Japanese statutory labelling

Product identity, responsible Japanese company details, lot identification, ingredient / active-ingredient information and applicable warnings vary by classification.

Advertising & positioning

Beauty claims do not automatically qualify for medicinal advertising. The local party should check cartons, websites and Japanese sales material.

05.4 - What does Japan Customs verify?

Japan Customs checks relevant documentary evidence under the PMD Act for commercial imports, in addition to normal value, tariff, origin and shipment information. The genuine Customs importer and the legally responsible Japanese MAH are not automatically the same company. If the Japanese buyer lacks the relevant licence, the licensed party and appointed customs broker must confirm an acceptable declaration arrangement before booking. Changing only a Consignee field does not resolve this issue.

A commercial category is not a regulatory shortcut

Calling a product "personal care", "beauty", "natural" or "cosmeceutical" does not allow it to bypass Japanese cosmetics or quasi-drug rules. Gemslinks provides logistics coordination; only properly authorised Japanese parties and competent authorities can determine and complete the regulated steps.

06

Batch Evidence, Compliance & Market Release

Are Laboratory Tests or Quality Checks Needed for Every Shipment?

Use manufacturer documentation efficiently while keeping quality decisions with the appropriately licensed Japanese party.

A manufacturer may supply batch manufacturing records, specifications, a Certificate of Analysis (CoA) and other technical evidence to the responsible Japanese party. The applicable quality system and any approved quasi-drug particulars determine the necessary assessment, checks, records and market-release decision. There is no single laboratory test panel that applies to every cosmetic or personal-care shipment.

Manufacturer batch records

Provide lot number, production details, product specification and manufacturing-site information for the batches being shipped.

Certificates of Analysis

Where appropriate, CoA, microbiological, stability and other manufacturer evidence can inform the Japanese MAH review.

Additional checks when needed

The responsible MAH determines further tests or corrective action based on product class, dossier, quality risks and available records.

Market-release decision

The licensed MAH maintains quality and safety responsibility and controls release for Japanese distribution; Customs permission is a separate action.

What supporting information helps regular shipments run smoothly?

Evidence / Information	Source	Why it matters
Lot and production identification	Overseas manufacturer	Connects the physical shipment to manufacturer quality and traceability records.
CoA and agreed batch specifications	Manufacturer / testing organisation	Supports the appropriate quality assessment without presuming every laboratory test must be repeated.
Changes to formula, site or labels	Overseas manufacturer	May trigger further review, notification / approval work or an updated shipment plan.
Transport-specific safety data	Manufacturer / supplier	Supports carrier acceptance for alcohol-rich, aerosol, pressurised or otherwise restricted products.

Regulatory decisions stay with the Japanese licensed party

Gemslinks does not certify formulas, issue approvals, decide sampling frequency or perform statutory market-release judgement. Detailed quality procedures and any necessary handling are agreed with the responsible licensed party for the actual product and shipment.

07

Trade Entry, Authorised Market Supply & Resale

When Can Imported Personal Care Products Be Sold in Japan?

Customs clearance and domestic market release are distinct, whether the product is skincare, toothpaste, a medicated shampoo or another regulated personal-care product.

Customs import permission

The authorised customs broker handles declaration, supporting PMD Act documentation, valuation, tariff code and any import duties / taxes.

Regulated market release

The appropriately licensed Japanese MAH manages the applicable product and quality requirements before market supply.

Delivery to the buyer

After the necessary import and regulatory steps, the agreed domestic delivery can be arranged for the salon, distributor or retailer.

Domestic retail and advertising

A downstream seller normally does not need an MAH licence simply to resell products that were lawfully marketed, but labels and claims must remain compliant.

Keep the records and milestones distinct

Milestone	Main Evidence	Responsibility / Outcome
Product regulatory readiness	Correct cosmetics / quasi-drug MAH licence and applicable notifications or marketing approval.	Japanese licensed party confirms the product can enter the intended commercial arrangement.
Customs import entry	Commercial Invoice, Packing List, B/L or AWB, declaration and relevant PMD Act documents.	Appointed customs broker seeks permission from Japan Customs.
Quality and market release	Applicable lot, quality and authorised release records.	Licensed MAH authorises Japanese market supply.
Retail supply	Agreed domestic delivery instructions and appropriate Japanese labelling / claims.	Japanese buyer receives goods for lawful resale under the agreed commercial arrangement.

Japan Customs permission is not a product marketing approval

The Customs import permission for the shipment, the product-specific quasi-drug approval (where required), and the Japanese MAH market-release decision are separate. A Japanese buyer without an MAH licence may resell lawfully marketed products, but that does not itself authorise the buyer to market unapproved or unreleased imports.

08

Budget, Lead Time & Commercial Feasibility

What Costs and Delays Should Overseas Personal Care Brands Expect?

A firm shipping quote is only useful once the product classification and necessary Japanese licensed-party scope are understood.

The first shipment normally requires more coordination than replenishments. Product-specific quasi-drug approval is not the same as a routine cosmetics notification and may become the main lead-time item. A realistic quotation separates regulatory partner services, ordinary freight, Customs charges and conditional costs.

Cost / Timing Area	What Can Affect It	When It Matters
Initial classification and partner review	Product purpose, ingredients, proposed claims and the correct Japanese MAH must be confirmed.	First product or range; may repeat following material changes.
Ordinary cosmetics filings and labels	Applicable foreign / product notification, statutory display review and quality documentation.	First marketing setup and subsequent changes where required.
Quasi-drug approval and foreign accreditation	Product dossier, marketing approval, related technical evidence and overseas-site accreditation can require substantial coordination.	Quasi-drugs; allow longer lead time and more involved costs than ordinary cosmetic notification.
International freight / transport safety	Pickup, air / sea charges, packaging, acceptance of perfumes, aerosols, liquids and any dangerous-goods surcharges.	Every shipment as applicable.
Japan Customs brokerage and taxes	Import declaration, arrival charges, duties if any and import consumption tax.	Per entry, with true importer and paying party agreed.
Domestic transport and conditional handling	Agreed delivery route and any handling under the licensed party's regulatory arrangements.	Actual shipment plan and selected Japanese partner.
Changes, testing or delays	Formula changes, incomplete dossier, rejected claims, inspection hold, storage or rework.	Only when triggered; allocate by agreement and evidence.

Common reasons the first import is delayed

Incorrect classification

A medicated toothpaste, shampoo or skincare product is treated as a normal cosmetic without first checking active ingredients and claims.

Product approval not ready

A quasi-drug requires a relevant MAH, product approval or foreign-manufacturer accreditation before lawful marketing.

Incomplete technical records

Missing precise formula, active ingredient, manufacturing-site or quality information prevents meaningful review.

Shipping restrictions

Perfume, alcohol-based products and aerosols can trigger dangerous-goods reviews or carrier restrictions.

Changed products on repeat orders

New formulations, manufacturing sites, label claims or product variants may require renewed regulatory and shipping checks.

09

Gemslinks Coordination & Repeat Shipments

How Gemslinks Supports Cosmetics and Personal Care Imports into Japan

Gemslinks is a freight forwarder and logistics coordinator. We focus on the practical route from an overseas brand with a Japanese buyer to accepted repeat imports.

Already have a Japanese buyer but no complete import arrangement? Gemslinks helps assess the practical logistics and coordinate the trade flow for accepted commercial projects. When an appropriate Japanese licensed cosmetics or quasi-drug partner is not yet in place, we may explore potential coordination subject to the product, partner acceptance and agreed commercial scope.

Product and order feasibility

Review origin, products, Japanese buyer, order quantities, transport mode and the initial regulatory classification needs.

Japan-side role coordination

Clarify which Japanese licensed party is responsible for the applicable product class and how it interfaces with the shipment.

International freight and Customs

Coordinate agreed overseas pickup, sea or air freight, shipping documentation, appointed Japanese customs broker and domestic delivery.

Ongoing replenishment

After the first accepted shipment, coordinate repeat bookings, batch-related shipping data and delivery requirements.

Start with an actual product and an identified Japanese buyer

Useful details for your first enquiry

Overseas manufacturer / brand name and manufacturing country.
Product names, website / photos, intended uses and any "medicated" or active-ingredient claims.
Japanese buyer: salon, cosmetics retailer, distributor or other business; order status.
Whether a licensed Japanese cosmetics / quasi-drug marketing party is already involved.
Estimated units, cartons, gross weight, shipment value, pickup origin and Japanese destination.
First shipment date and expected ongoing replenishment frequency.

For an initial logistics discussion, a product brief and commercial order information are more useful than asking the overseas brand to submit its entire confidential formula upfront. Detailed technical information can be reviewed by the appropriate licensed Japanese party when feasibility has been established.

Practical FAQ - Imports, Licences & Personal Care Products

Questions About Cosmetics, Toothpaste, Quasi-Drugs and Japan Imports

Does this guide cover toothpaste, shampoo and personal care products?

Yes. The commercial scope includes skincare, makeup, haircare, soaps, toothpaste, oral care and selected medicated products. However, Japan classifies each product under its actual legal category; "personal care" is not a regulatory licence class.

Is toothpaste a cosmetic or a quasi-drug in Japan?

Both are possible. Basic toothpaste may be a cosmetic; many fluoride-containing and other medicated toothpastes are quasi-drugs. Check the actual formula and claims before choosing a Japanese partner or filing route.

Can a Japanese beauty salon buy and resell products without its own MAH licence?

A downstream salon or retailer can generally resell cosmetics and quasi-drugs that have been lawfully marketed and released by an appropriately licensed Japanese party. This differs from independently placing unapproved imported products on the market.

Our overseas brand already has Japanese buyers. Do we need our own company in Japan?

Not always. An appropriate Japanese licensed business may undertake the regulated marketing role under a viable arrangement. The specific product, commercial structure and Japanese partner acceptance determine feasibility.

Can Gemslinks introduce or coordinate with a Japanese cosmetics / quasi-drug partner?

For a concrete commercial shipment, we can assess the logistics and explore appropriate Japan-side coordination case by case. This is not a guarantee of partner availability, product acceptance or regulatory approval.

Does a cosmetics MAH licence also cover quasi-drugs?

No. The business licence must cover the actual product class. A cosmetics-only marketing authorisation does not by itself authorise quasi-drug marketing.

Do ordinary cosmetics require product-specific government approval?

Generally, ordinary cosmetics use a cosmetics MAH business licence and product / foreign-party notification route, not the usual quasi-drug product approval pathway. Special ingredients or other classifications can change the result.

Do quasi-drugs require product-by-product approval?

Generally yes. A quasi-drug MAH must review the applicable marketing approval pathway and any statutory exceptions. This may involve a product dossier and foreign manufacturing-site accreditation, and takes more planning than a normal cosmetics notification.

What is the difference between C73 and foreign quasi-drug manufacturer accreditation?

C73 is the foreign cosmetics manufacturer / marketer notification route. Quasi-drugs have separate foreign manufacturer accreditation requirements where applicable; the two are not interchangeable.

Can Japanese retail labels be attached at the overseas factory?

Potentially, after the responsible Japanese party confirms the mandatory particulars, applicable category and permissible claims. Overseas labelling alone is not approval to distribute the goods in Japan.

Is every imported batch subject to a full Japanese laboratory test panel?

There is no universal full laboratory test panel for all personal care shipments. The licensed MAH decides required records, checks and any additional testing under the applicable quality and product requirements.

Can a buyer without an MAH licence be named as the Customs importer?

Certain multi-party arrangements are possible but require careful review of the real sale and import declaration authority. The Japanese licensed party and appointed customs broker must confirm the structure before shipping.

Does Customs import permission automatically allow retail sale?

No. Customs entry and lawful Japanese market release are different. Relevant product approvals or notifications and regulated release responsibilities must also be satisfied.

Can we start with a small commercial sample order?

A small shipment intended for commercial sale or distribution is not automatically outside the Japanese regulated import system. The actual purpose and applicable exemptions must be checked.

Are perfume, aerosols and nail care liquids accepted by carriers?

Some are dangerous goods or otherwise restricted because of alcohol, flammability or pressure. Carrier acceptance, packing and safety data should be reviewed before booking.

Can Gemslinks coordinate regular shipments after the first import?

For accepted projects, we can help coordinate repeat bookings, documents, customs-broker contact and agreed domestic deliveries while the licensed Japanese party maintains the product and market-release responsibilities.

These official resources explain Japanese cosmetics / quasi-drug classification, responsible licences, product notifications or approvals, foreign manufacturers, labelling and Customs. Rules should be checked for the actual product and shipping date.

Japanese Government References for Cosmetics and Quasi-Drugs

Use these official sources to verify the product category, licensed responsible party, notifications, Japanese labels and Customs arrangements. Relevant regulations and authority guidance should be rechecked for the actual product and shipment date.

Tokyo - Cosmetics and the PMD Act

Japanese cosmetics marketing and manufacturing licences; respective responsibilities. Official source →

Tokyo - Quasi-Drug Manufacturing and Marketing

Separate Japanese quasi-drug MAH, foreign manufacturer accreditation and product approval requirements. Official source →

PMDA - Quasi-Drug Marketing Approval

Product-specific approval route and examples, including medicated toothpaste classes with delegated approval authority. Official source →

PMDA - Foreign Manufacturer Procedures

Foreign quasi-drug manufacturing-site accreditation / registration procedures. Official source →

MHLW - Toothpaste Classification

Explains cosmetic toothpaste and quasi-drug toothpaste in Japan, including medicated ingredients. Official source →

Tokyo - Before Marketing Cosmetics

Product classification, ingredient review and steps prior to marketing ordinary cosmetics. Official source →

Tokyo - Cosmetic Product Marketing Notifications

Cosmetic MAH product notification and relevant filing information. Official source →

PMDA - Foreign Cosmetic Manufacturer Notification

Cosmetics C73 notification and official instructions. Official source →

MHLW - Japanese Cosmetic Standards

Official cosmetic ingredient restrictions and related rules. Official source →

Tokyo - Cosmetics Statutory Labelling

Responsible MAH particulars, ingredients, lot information and other Japanese label requirements. Official source →

Japan Customs - PMD Act Import Verification

Evidence required for Japan Customs import clearance involving regulated cosmetics and quasi-drugs. Official source →

Japan Customs - Importer of Record Case Studies

Transaction-based Customs importer identity and multi-party import arrangements. Official source →

MHLW - Import Procedures Q&A (June 2025)

Official questions including situations where the Customs importer and MAH are separate. Official source →

MHLW - Advertising and Claims

General advertising restrictions for regulated health and beauty products. Official source →

Official sources reviewed 25 October 2026. This page is general business guidance, not an approval, licence or guarantee. Applicable requirements depend on classification and the current rules; Japanese licensed parties and authorities make the relevant regulatory decisions.