Japan PMD Act: Importing and Selling Drugs, Medical Devices and Cosmetics

What is the Pharmaceutical and Medical Device Act (PMD Act)?

The Pharmaceutical and Medical Device Act regulates the quality, efficacy, and safety of pharmaceuticals, quasi-drugs, cosmetics, medical devices, in vitro diagnostic drugs, regenerative medicine products, and similar items.

The official name is the "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc."

In import operations, it is important when determining whether a product brought in from overseas falls under food, cosmetics, pharmaceuticals, or medical devices.

Even if the appearance suggests general goods, health foods, beauty products, testing supplies, or health instruments, the product may be subject to the PMD Act depending on its ingredients, usage, labeling, advertising expressions, or sales purpose.

The PMD Act concerns not only the physical form of the product. Whether certain permissions, approvals, certifications, notifications, registrations, or import confirmation certificates are required depends on the ingredients contained, intended use, displayed or advertised efficacies, and whether the product is imported or sold commercially.

Scope Covered in This Article

Item	Content Covered in This Article	Details Covered in Other Articles
Basics of the PMD Act	Outlines the overall framework of the law regulating pharmaceuticals, quasi-drugs, cosmetics, medical devices, and in vitro diagnostic drugs.	Detailed procedures by individual category are organized in respective specialized articles.
Classification of Target Categories	Clarifies the differences between pharmaceuticals, quasi-drugs, cosmetics, medical devices, in vitro diagnostic drugs, and regenerative medicine products.	Details on quasi-drugs, cosmetics, medical devices, and in vitro diagnostic drugs are addressed in individual articles.
Boundary Determination in Import Sales	Summarizes situations where applicability of the PMD Act is an issue in foods, health foods, cosmetics, general goods, beauty equipment, and testing supplies.	Ingredient confirmation for health foods and food regulatory systems are covered in "Health Foods and the PMD Act."
Pharmaceutical-like Efficacy Claims	Summarizes risks related to labeling and advertising claims concerning disease treatment, prevention, improvement, or effects on bodily functions.	Judgment criteria for advertising expressions are covered in detail in "Pharmaceutical-like Efficacy Claims."
Permissions, Approvals, Certifications, Notifications	Clarifies differences among Manufacturing and Marketing Authorization, manufacturing registration, product approvals, certifications, notifications, and foreign manufacturer procedures.	Individual cosmetic and medical device permissions and notifications are organized in respective specialized articles.
Import Confirmation Certificates	Addresses situations where import confirmation certificates may be required for non-commercial import, testing/research use, exhibition, personal use, or treatment purposes.	Specific requirements for application necessity and quantity conditions should be checked by the importer with the regional health bureau or relevant authorities.
Differences from the Food Sanitation Act and Other Laws	Clarifies the respective roles of the PMD Act, Food Sanitation Act, Food Labeling Act, Act against Unjustifiable Premiums and Misleading Representations, and product safety-related laws.	Details on food import inspections and labeling are covered in food-related articles.
Relationship with Marine Cargo Insurance	Clarifies that procedural noncompliance or inability to sell under the PMD Act pose risks different from typical cargo incidents.	The scope of coverage and handling of incidents for marine cargo insurance are covered in marine cargo insurance and cargo incident articles.
Freight Forwarder and Customs Practicalities	Outlines matters freight forwarders should confirm, document collection, information sharing with customs brokers, and how to avoid definitive statements.	Final judgments on applicability of the PMD Act and sales feasibility should be confirmed by importers, regulatory affairs personnel, administrative offices, or experts.

Purpose and Background of the System

The PMD Act is a system to ensure the quality, efficacy, and safety of pharmaceuticals, quasi-drugs, cosmetics, medical devices, and in vitro diagnostic drugs to prevent public health hazards.

In import sales, simply bringing products distributed overseas into Japan is not sufficient. It is necessary to confirm which category the item falls under in Japan and what permissions, approvals, certifications, notifications, registrations, labeling, and advertising controls are required.

Products sold overseas as food, cosmetics, general goods, research materials, or health instruments may correspond to items regulated by the PMD Act in Japan.

Therefore, the PMD Act is a system requiring integrated checks not only at customs clearance but also prior to procurement, during import arrangement, domestic storage, labeling, advertising, and ongoing sales management.

Main Categories Covered by the PMD Act and Products Likely to Require Confirmation

Under the PMD Act, the first important decision is which category the product belongs to.

In import operations, classification should be confirmed not only by product name or HS code but also including ingredients, intended use, labeling, advertising, and sales methods.

Category	Main Content	Products Commonly Problematic in Import Operations	Items to Confirm
Pharmaceuticals	Products used for diagnosis, treatment, or prevention of diseases, or those that affect the structure or function of the body.	Tablets, capsules, liquids, ointments, eye drops, overseas supplements, herbal products, folk medicines	Confirm ingredients, claimed effects, approvals, Manufacturing and Marketing Authorization, and import purpose.
Quasi-drugs	Products with milder effects than pharmaceuticals aiming for certain efficacy.	Medicated cosmetics, medicated toothpaste, hair growth agents, deodorants, disinfectants, insect repellents	Confirm active ingredients, claimed effects, approvals, Manufacturing and Marketing Authorization, and advertising expressions.
Cosmetics	Products used to cleanse, beautify, enhance attractiveness, alter appearance, or maintain healthy skin and hair.	Skin care, makeup products, hair care, perfumes, soaps, sunscreens	Confirm cosmetic standards, full ingredient disclosure, Manufacturing and Marketing Authorization, product notifications, and advertising expressions.
Medical Devices	Equipment and instruments used for diagnosis, treatment, or prevention of diseases, or those affecting body structure or function.	Blood pressure monitors, thermometers, hearing aids, contact lenses, measurement devices, beauty devices, therapeutic devices	Confirm medical device applicability, classification, approvals, certifications, notifications, and Medical Device Marketing Authorization License.
In Vitro Diagnostic Drugs	Diagnostic drugs and test kits for analyzing human specimens outside the body.	Infectious disease test kits, pregnancy tests, ovulation tests, diagnostic reagents, measurement reagents	Confirm test purpose, specimen type, approvals, certifications, notifications, and differentiation from research use.
Regenerative Medicine Products	Includes cell-processed products and gene therapy products.	Cell-processed related products, gene therapy related products	Confirm specialized pharmaceutical regulatory compliance, approvals, quality control, and safety management.
General Products that May Look Outside the PMD Act Scope	Products treated as food, sundries, beauty items, research supplies, or health devices.	Supplements, beauty devices, testing supplies, hygiene products, health goods	Confirm whether ingredients, efficacy claims, usage purpose, and advertising expressions place the product under the PMD Act.

Applicable Requirements and Exclusions

Category	Situations Requiring PMD Act Confirmation	Situations Often Excluded or Treated Separately	Practical Notes
Food and Health Foods	When containing pharmaceutical ingredients, claiming treatment or prevention of diseases, or strong claims of effects on bodily functions.	Nutrition as food, general health maintenance, or products with typical food labeling are handled under food regulations.	Even if confirmed under the Food Sanitation Act, advertising expressions under the PMD Act may still pose issues.
Cosmetics	Claims for treatment of skin diseases, hair growth, inflammation improvement, cell regeneration, or medicated effects.	Products limited to cleansing, beautification, attractiveness enhancement, or maintaining healthy skin and hair are treated as cosmetics.	Importing as cosmetics may be possible, but advertising beyond cosmetic scope may violate the PMD Act.
Quasi-drugs	Claims of medicated, whitening, hair growth, hair removal, sterilization, deodorization, or insect repellent effects.	General beauty or hygiene products without medicated claims may be categorized as cosmetics or sundries.	Confirm active ingredients, claimed effects, and approval scopes.
Medical Devices and Health Instruments	Devices claiming diagnosis, treatment, prevention, measurement, body function improvement, or pain relief.	General exercise support, beauty, or relaxation devices may be treated individually.	Even beauty devices and health instruments may be considered medical devices depending on labeling and function.
In Vitro Diagnostic Drugs	Test reagents and test kits using human-derived specimens to judge diseases or physical conditions.	When limited to research use and not sold for diagnostic purposes, they are treated separately.	Labeling as Research Use Only may not fully determine domestic sales and advertising purposes.
Test, Research, Exhibition, and Internal Sample Use	Even imports of PMD Act-regulated items for non-commercial use may require import confirmation certificates.	Clearly general goods or items outside the PMD Act may be exempt from import confirmation under the PMD Act.	Be prepared to explain import purpose, quantity, place of use, non-sale, and post-use disposal.
Personal Importation	When exceeding personal use for domestic sale, resale, distribution, or business use.	Personal use within a certain range is handled separately from commercial importation.	Successful personal import does not guarantee domestic sale or advertising approval.
Cargo Insurance	When customs clearance or sales are stopped due to PMD Act non-compliance, treated as a legal risk separate from cargo incidents.	Physical damages caused by accidental incidents during transport are considered under cargo insurance.	Do not confuse PMD Act risks with cargo incident risks.

Pharmaceuticals

Pharmaceuticals are products used for the diagnosis, treatment, or prevention of diseases, or those intended to affect the structure or function of the body.

They may be classified as pharmaceuticals not only by form such as tablets, capsules, liquids, ointments, or eye drops, but also by their ingredient composition and claimed effects.

In import operations, products sold overseas as supplements, health foods, herbal products, folk medicines, or topical creams may be categorized as pharmaceuticals in Japan.

If the product qualifies as a pharmaceutical, importing and selling it without approval becomes a serious issue.

In particular, for products containing pharmaceutical ingredients, products claiming to treat or prevent diseases, or products indicating dosage or frequency of use like pharmaceuticals, pre-import PMD Act confirmation is required.

Quasi-Drugs

Quasi-drugs are a product category that does not aim for as strong an effect as pharmaceuticals but can display certain efficacy claims.

There are cases where medicated cosmetics, medicated toothpaste, antiperspirants, hair growth agents, insecticides, and disinfectant-related products cause issues.

For import and sale, it is necessary to confirm whether the product can be treated simply as a cosmetic or if it qualifies as a quasi-drug.

Statements such as medicated, whitening, hair growth, hair removal, sterilization, disinfection, deodorization, insect repellent, and the presence of active ingredients could require handling the product as a quasi-drug rather than a cosmetic.

Cosmetics

Cosmetics are products used to cleanse, beautify, enhance attractiveness, alter appearance, or maintain healthy skin and hair.

Their effects are limited to mild action, and they cannot claim pharmaceutical-like therapeutic effects.

In import practice, skin care products, makeup items, hair care products, perfumes, soaps, and body care products may fall under cosmetics.

Even if marketed internationally as general goods or beauty products, when selling as cosmetics in Japan, it is necessary to verify Manufacturing and Marketing Authorization, manufacturing license, product-specific notifications, full ingredient labeling, and compliance with cosmetic standards.

Medical Devices

Medical devices are machinery, instruments, or tools used for the diagnosis, treatment, or prevention of diseases, or those intended to affect the structure or function of the human body.

This includes not only large medical equipment but also measuring instruments, therapeutic devices, assistive devices, home-use devices, beauty devices, health equipment, and software.

In import practice, blood pressure monitors, thermometers, hearing aids, contact lenses, massage devices, measuring devices, beauty devices, and therapeutic apparatus may present medical device classification issues.

Products sold as general goods or beauty devices may nonetheless qualify as medical devices depending on labeling, functions, or intended use.

In Vitro Diagnostic Drugs

In vitro diagnostic drugs are reagents used with specimens derived from the human body, such as blood, urine, or saliva, for diagnosing diseases or checking conditions.

There are cases where test kits, diagnostic reagents, and infectious disease test-related products may cause problems.

In import practice, even products labeled for research use, home use, or self-testing may fall under in vitro diagnostic drugs depending on actual use and labeling.

Since the main testing devices are considered medical devices, and dedicated reagents or cartridges as in vitro diagnostic drugs, these should be separately confirmed as device, reagent, and software.

PMD Act Issues in Import Practice

The PMD Act is most often triggered when the products to be imported are those that act on the human body, relate to health or beauty, or are connected to disease diagnosis, treatment, or prevention.

• Importing and selling overseas cosmetics
• Displaying efficacy claims on supplements or health foods
• Importing beauty devices, measuring instruments, or therapeutic devices
• Handling test kits or diagnostic products
• Importing products containing pharmaceutical-like ingredients
• Claims of disease names, treatment, prevention, or improvement in sales pages or advertisements
• Products sold overseas as general goods but potentially affecting the human body in Japan
• Re-selling imported personal use items domestically
• Importing for research, exhibition, or internal sample use

The PMD Act checks not only the product name or the declared import item name but also the actual ingredients, uses, labels, advertisements, and sales forms.

Even if overseas suppliers describe products as supplement, cosmetic, wellness product, beauty device, or research use only, the legal classification under Japanese law must be determined separately.

Boundary Decisions for Food, Cosmetics, Pharmaceuticals, etc.

One of the most important aspects in PMD Act practice is clearly distinguishing between food, cosmetics, pharmaceuticals, quasi-drugs, and medical devices.

Especially for health foods, supplements, beauty-related products, hygiene products, test kits, measuring instruments, and health devices, misclassification may make import and sale impossible.

Decision Axis	Items to Confirm	Common Issues	Practical Points of Attention
Ingredients	Confirm whether the product contains pharmaceutical ingredients, effective ingredients of quasi-drugs, banned ingredients, or regulated substances.	Cases where overseas supplements include ingredients regarded as pharmaceuticals in Japan.	Check ingredient lists, specifications, COA, and content amounts.
Efficacy Claims	Check if the product claims treatment, prevention of disease, improvement of bodily functions, or pharmaceutical-like effects.	Food claiming to lower blood sugar, cosmetics claiming to heal inflammation, beauty devices claiming therapeutic effects.	Verify not only labels but also sales pages, SNS, advertisements, and testimonials.
Purpose of Use	Confirm the intended purpose regarding how the product acts on the body.	Items imported as general goods but actually used for medical judgment or treatment purposes.	Check usage explanations, target users, sales destinations, and usage situations.
Form and Dosage	Verify if tablets, capsules, ampoules, and dosage instructions resemble pharmaceutical use.	Food sold with dosage frequency or symptom-specific usage instructions.	Check product form, dosage instructions, manuals, and label expression.
Sales Form	Confirm if for personal use, commercial sale, medical institutions, or general consumers.	Cases where personal imports are diverted to domestic sales.	Verify import purpose, sales destination, sales quantity, and whether sold via e-commerce.

Risks of Pharmaceutical-Like Efficacy Claims

Under the Pharmaceutical and Medical Device Act (PMD Act), displaying or advertising unapproved products with pharmaceutical-like efficacy claims is problematic.

For example, expressions such as "cures diseases," "lowers blood pressure," "improves diabetes," "boosts immunity to prevent infections," or "effective against cancer" may be considered pharmaceutical efficacy claims and could pose issues.

If such claims are made, even if the products were imported as food or general goods, there is a risk they may be treated as unapproved and unauthorized pharmaceuticals.

Products deemed unapproved and unauthorized pharmaceuticals may be subject to sales suspension, advertisement corrections, recalls, administrative guidance, import suspension, or criminal penalties.

In actual logistics practice, it is necessary to check not only the item classification at import but also sales pages, product labels, advertising texts, SNS posts, brochures, and instruction manuals.

Main Permits, Notifications, and Approvals Required for Import

When importing and selling pharmaceuticals, quasi-drugs, cosmetics, medical devices, in vitro diagnostics, etc., as a business, various permits, registrations, notifications, approvals, and certifications may be required depending on the item and business type.

Procedure	Main Content	Commonly Related Categories	Common Causes for Halt
Marketing Authorization Holder Permit	This permit designates the entity responsible for shipping products to the market in Japan.	Pharmaceuticals, quasi-drugs, cosmetics, medical devices, etc.	Occurs when the importer considers themselves merely as a seller and has not designated a Marketing Authorization Holder.
Manufacturing Business Permit / Registration	Permit or registration for locations where storage, packaging, labeling, and other activities are conducted domestically.	Pharmaceuticals, quasi-drugs, cosmetics, medical devices, etc.	When labeling or storage at logistics warehouses is regarded as normal logistics work rather than manufacturing activities.
Approval for Individual Items	Procedure to conduct quality, efficacy, and safety review for individual items.	Pharmaceuticals, quasi-drugs, medical devices, in vitro diagnostics, etc.	Misunderstanding that individual products can be sold as long as there is a business permit.
Certification	Procedure where registered certification bodies confirm compliance of controlled medical devices, etc. with standards.	Medical devices, in vitro diagnostics, etc.	Failure to confirm whether the product is subject to certification or approval.
Notification	Procedure to notify sales names, generic names, Marketing Authorization Holders, etc. for certain items.	Cosmetics, general medical devices, etc.	Misunderstanding that only notification is required and other permits or registrations are not necessary.
Procedures Related to Foreign Manufacturers	Accreditation, registration, notification, etc. concerning overseas manufacturing sites.	Pharmaceuticals, quasi-drugs, medical devices, cosmetics, etc.	Inability to obtain manufacturing site information from overseas manufacturers.
Import Confirmation Certificate	Procedure for confirmation of import for specific purposes other than business sales.	Pharmaceutical products, medical devices, etc.	Failure to verify whether procedures are necessary for imports intended for testing, research, or exhibition.

Marketing Authorization Holder Permit

Businesses responsible for placing pharmaceuticals, quasi-drugs, cosmetics, medical devices, etc. on the Japanese market may require a Marketing Authorization Holder permit.

The Marketing Authorization Holder is responsible for quality control, safety management, labeling, recall responses, and post-market safety measures.

Even for imported products, responsibility as a Marketing Authorization Holder may become an issue when selling in Japan, rather than being a simple importer.

It is necessary to clarify before import who will be the Marketing Authorization Holder, whether your company will obtain the permit, or if it will be outsourced to an existing permit holder.

Manufacturing Business Permit / Registration

If activities such as packaging, labeling, storage, affixing labels, or pre-shipment storage judgment are performed on imported products, a manufacturing business permit or registration may be required.

Which activities fall under this permit or registration depends on item category and business activities, such as pharmaceuticals, quasi-drugs, cosmetics, or medical devices.

When replacing labels, repackaging, or performing pre-shipment storage on products manufactured overseas in Japan, it is necessary to individually verify the need for a manufacturing business permit or registration under the PMD Act.

Even if the activities are conducted at a logistics warehouse, it is important to distinguish between normal storage and storage or labeling activities classified as manufacturing under the PMD Act.

Approvals, Certifications, and Notifications for Individual Items

Individual approvals, certifications, or notifications may be necessary for pharmaceuticals, quasi-drugs, medical devices, in vitro diagnostics, etc.

The level of procedural requirements varies depending on risk classification and product type.

For cosmetics, the usual practice is that a business holding Manufacturing and Marketing Authorization for cosmetics submits notifications for each product.

For medical devices, requirements to notify, certify, or approve depend on the classification: general medical devices, controlled medical devices, specially controlled medical devices, and other categories.

Having a business permit does not mean that individual items can be marketed without further procedures.

Procedures Related to Foreign Manufacturers

When importing and selling pharmaceuticals, quasi-drugs, medical devices, etc. manufactured overseas into Japan, accreditation or registration of foreign manufacturers may be required.

In cosmetics, notifications related to foreign Marketing Authorization Holders and foreign manufacturers may also be an issue.

It should be noted that procedures cannot be completed solely by the importer; information and cooperation from the overseas manufacturer are necessary.

In particular, information such as the manufacturing site name, location, manufacturing process, quality control system, and person responsible must be provided by the foreign manufacturer for procedures to proceed.

Even if the importer intends to sell in Japan, if the overseas manufacturer cannot provide necessary information, procedures under the PMD Act may not progress.

Relationship Between Import Confirmation Certificate and Customs Clearance

When importing products subject to the PMD Act, procedures vary depending on the import purpose: whether for commercial sales, testing and research, personal use, or use by medical professionals for patient treatment.

The verification procedure formerly known as "Yakukan Certificate" is now organized under the name "Import Confirmation Certificate."

The Import Confirmation Certificate is a document used to verify that imported products subject to the Pharmaceutical and Medical Device Act (PMD Act) are imported for non-commercial purposes or for specific intended uses.

When importing and selling pharmaceuticals, etc. for commercial purposes, customs clearance is generally carried out on the premise of holding business licenses and approvals, certifications, or notifications for each item.

On the other hand, for purposes such as testing and research, in-house samples, exhibitions, personal use, or treatment, obtaining an Import Confirmation Certificate may be necessary.

In customs clearance practice, customs authorities may request confirmation of whether the goods fall under the PMD Act and the purpose of importation.

Importers need to confirm in advance whether the product is subject to the PMD Act, whether the purpose is commercial, and whether the necessary permits, approvals, or Import Confirmation Certificates are in place.

Differences from the Food Sanitation Act

The Food Sanitation Act is a law primarily focused on confirming the safety of foods, additives, utensils, and containers or packaging.

In contrast, the PMD Act concentrates on pharmaceuticals, quasi-drugs, cosmetics, medical devices, etc., focusing on effects on human health and body, efficacy, and medical purposes.

Therefore, even for the same imported product, it is not always possible to judge only by the Food Sanitation Act.

For health foods, supplements, beauty-related products, hygiene products, testing supplies, etc., it may be necessary to check compliance with both the Food Sanitation Act and the PMD Act.

For example, supplements require verification as food under the Food Sanitation Act, while advertising claims could potentially raise issues under the PMD Act regarding medicinal effects.

Comparison with Other Systems

System / Field	Main Compliance Targets	Differences from PMD Act	Points to Note in Import Practice
PMD Act	Pharmaceuticals, quasi-drugs, cosmetics, medical devices, in vitro diagnostic drugs, etc.	Confirms quality, efficacy, safety, medicinal effects, impact on the body, and medical purposes.	Verification includes ingredients, uses, labeling, advertising, and sales purposes.
Food Sanitation Act	Foods, additives, utensils, containers, packaging, etc.	Primarily confirms the safety and hygiene as food products.	Even if there are no issues as food, advertising claims that resemble medicinal effects may be problematic under the PMD Act.
Food Labeling Act	Food names, ingredients, nutritional content, allergens, labeling information, etc.	Focuses on accuracy of food labeling and providing information to consumers.	Check that functional or health claims do not conflict with expressions restricted under the PMD Act.
Act against Unjustifiable Premiums and Misleading Representations	Misleading representations and fairness of advertising, etc.	Confirms grounds for advertising and prevention of consumer misunderstanding.	Expressions that are acceptable under the PMD Act may still violate this act if the advertising lacks evidence.
Cargo Insurance	Physical damage to cargo due to accidental incidents during transport.	Does not inherently cover legal non-compliance or loss of saleability.	Risks under the PMD Act and risks of cargo accidents should be treated separately.

Relation to Marine Cargo Insurance

Even if import and sale are prohibited due to violations or procedural deficiencies under the PMD Act, such losses may not be covered by marine cargo insurance.

Ocean marine cargo insurance typically covers physical damage to cargo caused by accidental incidents occurring during transport.

In contrast, lack of permits, approvals, notifications, failure to obtain Import Confirmation Certificates, violations of ingredient regulations, inadequate advertising expressions, domestic sales bans, administrative guidance, recalls, destruction, or lost sales opportunities differ in nature from physical damage occurring in transit.

Therefore, costs related to being unable to sell due to PMD Act issues, customs delays or holds, return or destruction requirements, advertising corrections, or relabeling generally constitute legal compliance and sales management risks borne by the importer.

Freight forwarders and insurance personnel should be careful not to confuse PMD Act risks with cargo accident risks.

System Application Flow

Step	Items to Confirm	Main Documents	Actions if Issues Arise
1. Understanding Product Information	Check product name, purpose, ingredients, form, overseas labeling, sales pages, and advertising expressions.	Product catalogs, ingredient lists, overseas labels, overseas sales pages	If information is insufficient, obtain additional documents from the overseas supplier before ordering.
2. Organizing Candidate Classifications	Organize which category the product may fall under: pharmaceutical, quasi-drug, cosmetic, medical device, in vitro diagnostic drug, food, or miscellaneous goods.	Purpose explanations, specifications, user manuals, sales destination information	If unclear, conduct PMD Act confirmation before import arrangement.
3. Confirming Ingredients and Efficacy Claims	Check pharmaceutical ingredients, regulated ingredients, pharmaceutical efficacy claims, and treatment or prevention expressions.	Ingredient lists, standards, Certificate of Analysis (COA), advertising drafts, sales page drafts	If problematic expressions or regulated ingredients are present, review import eligibility and sales methods.
4. Confirming Necessity of Procedures	Check necessity of Manufacturing and Marketing Authorization, manufacturing permit or registration, approval, certification, notification, and foreign manufacturer procedures.	Copies of permits, approval, certification, notification documents, foreign manufacturer documents	If not obtained, reorganize import timing, sales start timing, and responsible party.
5. Confirming Import Purpose	Confirm whether the purpose is for commercial use, testing or research, in-house samples, exhibition, personal use, treatment, etc.	Import purpose statement, quantities used, usage location, post-use disposal explanation	If an import confirmation certificate is required, check procedures before customs clearance.
6. Organizing Customs Documents	Organize documents that can be submitted if requested by customs or customs brokers.	Permits, approval documents, ingredient lists, purpose explanations, import confirmation certificates, product documents	If documents are insufficient, supplement before shipping or airfreight arrangement.
7. Confirming Domestic Storage and Labeling	Verify that labeling, packaging, storage, attached documents, and label changes do not require manufacturing permits or registration under the PMD Act.	Warehouse information, work details, outsourcing contracts, labeling drafts	If necessary, check involvement of authorized manufacturers, registered operators, or Marketing Authorization Holders.
8. Confirming Sales and Advertising	Check expressions on EC sites, SNS, landing pages, advertisements, pamphlets, and sales materials.	Sales page drafts, advertising drafts, SNS post drafts, instructions	If pharmaceutical-type expressions or out-of-scope approval expressions appear, revise before starting sales.

Key Points to Confirm Before Import

• Whether the product falls under pharmaceuticals, quasi-drugs, cosmetics, medical devices, in vitro diagnostic drugs, etc.
• Whether ingredients include substances regulated in Japan
• Whether efficacy claims use pharmaceutical-type expressions
• Whether necessary permits, approvals, certifications, notifications for import and sales exist
• Whether accreditation, registration, or notification of foreign manufacturers is required
• Whether an import confirmation certificate is needed for purposes like testing, research, personal use, treatment, or exhibition
• Whether sales pages, advertisements, labels, and instructions comply with the PMD Act
• Whether confirmation of other laws such as the Food Sanitation Act, Act against Unjustifiable Premiums and Misleading Representations, Food Labeling Act, Household Goods Quality Labeling Act, and product safety regulations is needed
• Whether documents needed for customs clearance are complete
• Whether post-domestic-sale labeling, advertising, and recall responses have been confirmed

The applicability of the PMD Act is not a final decision made by customs brokers or freight forwarders.

If uncertain, importers should check with the pharmaceutical affairs division of the prefecture where their business is located, regional health bureaus, or experts.

Flow of Import Operations

Step	Main Items to Confirm	Common Causes for Delays
Purchase Consideration	Check product name, purpose, ingredients, overseas labeling, sales pages, and advertising expressions.	Assuming products sold as general goods overseas are treated the same in Japan.
Classification Confirmation	Confirm which category applies: pharmaceutical, quasi-drug, cosmetic, medical device, in vitro diagnostic drug, food, or miscellaneous.	Relying solely on product name or HS code for judgment.
Procedure Confirmation	Confirm Manufacturing and Marketing Authorization, manufacturing permits or registration, approvals, certifications, notifications, and foreign manufacturer procedures.	Finding necessary procedures incomplete after ordering the product.
Import Purpose Confirmation	Confirm whether for commercial use, testing or research, in-house samples, exhibition, personal use, or treatment.	Failing to check the need for an import confirmation certificate when purpose is not commercial.
Import Arrangement	Organize copies of permits, approval, certification, notification materials, import confirmation certificates, and product documents for customs clearance.	Discovering document shortages just before customs clearance.
Customs Confirmation	Respond to inquiries from customs, customs brokers, and related regulatory authorities.	Importer unable to explain product purpose or sales intent.
Domestic Storage and Labeling	Confirm labeling, packaging, storage, full ingredient labeling, attached documents, manufacturing permits or registration.	Failure to confirm whether domestic warehouse operations require permits or registration under the PMD Act.
Before Sales Launch	Review expressions on EC sites, advertisements, SNS, pamphlets, and sales materials.	PMD Act issues arise from advertising expressions after customs clearance.

Cases Commonly Problematic in Practice

Case	Common Issues	Documents to Check	Practical Notes
Importing overseas supplements as health foods	May contain ingredients classified as pharmaceuticals in Japan, or use pharmaceutical-like advertising expressions.	Ingredient list, specification sheet, COA, overseas advertisements, draft Japanese sales pages	Confirm ingredients and advertising expressions under both the Food Sanitation Act and the Pharmaceutical and Medical Device Act (PMD Act).
Selling overseas cosmetics in Japan	Includes ingredients not permitted in Japan or claims that exceed the scope of cosmetics.	Complete ingredient list, cosmetic standard reference materials, label drafts, advertisement drafts	Verify Manufacturing and Marketing Authorization, product notifications, and advertisement content.
Importing beauty devices as general merchandise	Medical device classification issues may arise due to claims like improving blood circulation, pain relief, fat breakdown, or medical-level effects.	Specifications, user manuals, draft sales pages, advertisement drafts, explanation of intended use	Check intended use, function, and advertising expressions rather than product name.
Importing test kits for research use	Even with "Research Use Only" labeling, if used for diagnostic purposes in domestic sales, it may be subject to regulation as in vitro diagnostics.	Test purpose, target specimens, customers, advertisement drafts, research use explanation	Confirm consistency between research explanation and actual use upon domestic sales.
Importing for testing, research, or exhibition purposes	May require import confirmation even if not for commercial purposes.	Import purpose explanation, quantity used, location of use, exhibition materials, post-use disposal explanation	Ensure non-sale, no transfer to third parties, and be able to explain post-use disposal.
Redirecting personal import items to domestic sales	Confusion between personal import for self-use and commercial domestic sales.	Purchase history, quantities, sales pages, delivery destinations, sales plans	Being able to import for personal use and being able to sell domestically are separate issues.
Labeling or re-labeling at domestic warehouse	May be considered manufacturing activity under the PMD Act, requiring approval or registration beyond normal logistics operations.	Warehouse information, work details, outsourcing contracts, label drafts, approval and registration information	Separate logistics storage from manufacturing operations under the PMD Act for confirmation.
Misunderstanding sales suspension due to PMD Act issues as cargo damage	Sales suspension or advertising changes due to regulatory compliance issues differ in nature from physical cargo damage during transport.	Insurance conditions, incident reports, customs inquiry responses, regulatory confirmation documents	Distinguish between risks from PMD Act compliance and cargo insurance claims.

Practical Scenario 1: Importing Overseas Supplements as Health Foods

There are cases where importers bring in supplements sold overseas as health foods and intend to sell them via e-commerce in Japan.

Although sold as dietary supplements abroad, the ingredient list may include components that Japan treats as pharmaceutical ingredients.

Moreover, overseas product pages might use expressions such as "blood sugar control," "anti-inflammatory," or "immune booster," which if translated directly into Japanese, could be problematic as pharmaceutical claims.

In such cases, it is necessary to check not only import confirmation under the Food Sanitation Act but also ingredient composition and advertising expressions under the PMD Act.

Practical Scenario 2: Selling Overseas Cosmetics in Japan

Importers may buy skincare products sold overseas as cosmetics and plan to sell them domestically in Japan.

Although marketed as cosmetics overseas, the products may contain ingredients prohibited or restricted in Japan.

Furthermore, if overseas advertisements include claims like "removes spots," "cures inflammation," or "regenerates cells," using them as-is in Japan could create issues under the PMD Act.

It is necessary to verify cosmetic standards, full ingredient disclosure, Manufacturing and Marketing Authorization, product notifications, and advertising wording.

Practical Scenario 3: Importing Beauty Devices as General Merchandise

Importers may bring in beauty devices from overseas as general merchandise and attempt to sell them in Japan.

Though sold abroad as beauty devices, the product descriptions may include claims such as "improves blood circulation," "relieves pain," "breaks down fat," or "medical level."

In this case, medical device classification or pharmaceutical-like claims could pose regulatory issues in Japan.

Importers should check intended use, physiological effects, labeling and advertising expressions, and sales destinations rather than solely relying on product names.

Practical Scenario 4: Importing Test Kits for Research Use

Importers may import test kits labeled overseas as Research Use Only.

However, if these are intended to be sold domestically for general consumers with advertisements like "check your disease at home," they could be regulated as in vitro diagnostic medical devices.

It is necessary to confirm if the product qualifies as research reagent, if it is regulated as an in vitro diagnostic medical device, and whether advertising claims are pharmaceutical in nature.

If the import purpose is described as research use but the actual domestic sales use differs, issues may arise during customs clearance or subsequent sales.

Practical Scenario 5: Importing for Testing and Research Purposes

Importers sometimes bring in items potentially classified as pharmaceuticals, medical devices, or in vitro diagnostics for internal testing or evaluation purposes.

Even if not for commercial purposes, import confirmation may be required.

Importers need to be able to explain the import purpose, location of use, quantities, post-use disposal plans, non-sale, and prohibition of transfer to third parties.

Freight forwarders and customs brokers should not assume that PMD Act confirmation is unnecessary because the import is not commercial. They need to check with the importer whether an Import Confirmation Certificate is required.

Practical Scenario 6: Cases Where Personal Imports Are Redirected for Domestic Sale

There are cases where individuals purchase pharmaceuticals, cosmetics, supplements, medical devices, etc., from overseas e-commerce sites for personal use and then attempt to sell them within Japan.

Personal imports for self-use and imports for commercial sale are treated separately.

Even products obtained through personal import may require compliance checks under the PMD Act, the Food Sanitation Act, the Food Labeling Act, the Act against Unjustifiable Premiums and Misleading Representations, etc., when sold or resold domestically.

Importers should not confuse the fact that goods can be obtained via personal import with the legality of selling them domestically in Japan.

Freight Forwarder and Customs Practice Perspective

For freight forwarders and customs brokers, the PMD Act is a frequently overlooked law for items such as food products, general goods, beauty products, health-related products, and measuring instruments.

Even if the shipper classifies items as “general goods,” “health foods,” “beauty goods,” “for research use,” or “samples,” PMD Act confirmation may still be necessary.

It is important that freight forwarders do not independently determine applicability under the PMD Act.

They should assess from the product description, usage, ingredients, labeling, advertising expressions, and sales purpose whether there is a possibility of the law applying and encourage the shipper to verify it.

Especially for supplements, cosmetics, beauty devices, sanitary products, testing kits, measuring instruments, and products claiming treatment or improvement, PMD Act confirmation, necessary permits, notifications, or Import Confirmation Certificates should be checked before shipment or air transport arrangement.

While freight forwarders are not decision-makers under the PMD Act, they are responsible for early detection of suspicious cargo and prompting importers and customs brokers to confirm compliance.

Scope of Freight Forwarder Involvement

Category	What they can assist with	What they should not definitively conclude	Practical response
Health Foods and Supplements	Request importers to submit ingredient lists, specifications, Certificates of Analysis (COA), usage explanations, and draft sales pages.	Should not conclude that the PMD Act does not apply merely because items are food.	Prompt importers to verify ingredients and advertising expressions.
Cosmetics and Beauty Products	Support collection of full ingredient lists, overseas labels, draft Japanese labeling, and advertising materials.	Should not conclude there are no issues just because the item looks like a cosmetic product.	Encourage confirmation of the distinction between cosmetics, quasi-drugs, and pharmaceuticals.
Beauty Devices and Health Equipment	Can urge verification of specifications, user manuals, usage purposes, and advertising expressions.	Should not conclude that the item is not a medical device simply because it is general goods or beauty equipment.	Prompt importers to confirm whether the item qualifies as a medical device.
Testing Kits and Research Reagents	Can prompt checks on target specimens, testing purpose, “Research Use Only” labeling, customers, and usage purpose.	Should not conclude these items are exempt from the PMD Act solely because they are marked “Research Use Only.”	Have the importer verify if they qualify as in vitro diagnostic drugs and confirm import purpose.
Test Research and Exhibition Cargo	Support collection of information on import purpose, quantity used, location of use, and post-use disposal explanations.	Should not conclude that Import Confirmation Certificates are unnecessary simply because items are not for commercial purposes.	Have importers confirm whether Import Confirmation Certificates are required.
When Customs Inquiries Are Made	Can organize product documentation, permit copies, approval, certification, notification documents, and Import Confirmation Certificate materials.	Freight forwarders should not make final judgments on import eligibility, sales authorization, or applicability under the PMD Act.	Share information with importers, customs brokers, and regulatory affairs personnel.

Documents Commonly Needed for PMD Act Confirmation

Document	Contents to Confirm	Purpose in Practice
Product Catalog	Product overview, use, target users, efficacy claims, and sales destinations	Confirm whether the product might fall under the PMD Act.
Ingredient Lists, Specifications, COA	Ingredients, content amounts, quality standards, test results	Check for pharmaceutical ingredients, regulated substances, cosmetic standards, and Food Sanitation Act relevance.
Usage Explanation Documents	Purpose, user, and method of use	Understand if the item qualifies as pharmaceutical, medical device, in vitro diagnostic pharmaceutical, etc.
Sales and User Explanation Documents	For medical institutions, research organizations, general consumers, or personal use	Clarify if the item is for commercial sale, research/testing, or personal use.
Overseas Label and Draft Japanese Labeling	Labeling, efficacy claims, usage instructions, precautions	Confirm that Japanese labeling complies with the PMD Act.
Sales Page Draft and Advertising Texts	Content on e-commerce sites, social media, landing pages, brochures, video scripts, testimonials	Check for pharmaceutical-like efficacy claims or expressions outside approval scope.
Copies of Permits	Marketing authorization, manufacturing permits, manufacturing registrations, etc.	Verify legality of responsible person for market shipment and domestic operation sites.
Approval, Certification, Notification Documents	Item-specific approvals, certifications, notifications, marketing names, generic names	Confirm whether the item’s sale is allowed in Japan.
Documents Related to Foreign Manufacturers	Overseas manufacturer names, locations, manufacturing scope, quality information	Used to verify foreign manufacturer accreditation, registration, and notifications.
Documents Related to Import Confirmation Certificates	Import purpose, quantity used, usage location, disposal after use, non-sale agreement	Used for confirming imports for study/research, exhibition, or personal use.

4-Column Judgment Checklist

Verification Stage	Party to Confirm With	Items to Verify	Action if Issues Arise
Purchase Consideration	Importer, Overseas Supplier	Product name, use, ingredients, overseas labeling, sales page, advertising expressions	If there is a possibility of being subject to the PMD Act, perform PMD Act compliance check before ordering.
Classification Confirmation	Importer, Regulatory Affairs Personnel, Experts	Classification among pharmaceuticals, quasi-drugs, cosmetics, medical devices, in vitro diagnostics, food, miscellaneous goods	Do not proceed with shipment or air freight arrangement unless classification is clear.
Ingredient and Advertising Check	Importer, Regulatory Affairs Personnel, Advertising Personnel	Pharmaceutical ingredients, restricted substances, pharmaceutical efficacy claims, advertising expressions	If problematic ingredients or expressions are found, review import approval and sales claims.
Procedure Confirmation	Importer, Marketing Authorization Holder, Regulatory Affairs Personnel	Manufacturing and Marketing Authorization, manufacturing permits/registrations, approvals, certifications, notifications, foreign manufacturer procedures	If not obtained, reschedule import timing and sales start date.
Import Purpose Confirmation	Importer, User Department, Customs Broker	Business use, R&D use, exhibition, personal use, therapeutic use classification	Confirm if import confirmation certificate is required, and prepare necessary documents accordingly.
Before Customs Declaration	Importer, Customs Broker, Freight Forwarder	Copies of permits, approval, certification, notification documents, import confirmation certificates, product information	If documents are insufficient, collect additional information from the importer before customs clearance.
Domestic Storage and Labeling	Importer, Warehouse, Marketing Authorization Holder, Manufacturer	Labeling, packaging, storage, pre-shipment storage, manufacturing permits/registrations	Separate logistics operations from manufacturing activities under the PMD Act.
Before Sales Launch	Importer, Advertising Personnel, Regulatory Affairs Personnel	EC site, SNS, landing pages, advertisements, brochures, sales materials expressions	Correct pharmaceutical-like claims and expressions beyond approved scope before starting sales.
Post-Sales Management	Importer, Sales Agents, Advertising Agencies	Advertisement updates, quotation of testimonials, campaign expressions, recall response system	Continuously manage any excessive or inappropriate expressions added after sales start.

Impacts When Customs Clearance or Sales Are Halted

If there are deficiencies in compliance with the PMD Act, delays in customs clearance, storage fees, delivery delays, postponement of sales launch, revision of advertisements or labels, reassignment of authorized operators, obtaining additional import confirmation certificates, returns, or disposal may occur.

Even if customs clearance is obtained, sales may not proceed domestically if labeling, advertising, permits, approvals, and notifications are not in order.

Under the PMD Act, clearance and sales should not be considered separately, but rather the process from pre-purchase to import, domestic storage, labeling, advertising, and post-sales management should be confirmed as an integrated flow.

Common Misunderstandings

Common Misunderstanding	Actual Perspective	Practical Points to Note
If it is a general product overseas, it can also be imported as a general product in Japan	Overseas classification and Japanese classification under the PMD Act may not match.	Check ingredients, usage, labeling, advertising, and sales purposes in Japan.
If HS code is decided, PMD Act confirmation is unnecessary	HS codes and classification under the PMD Act are separate determinations.	Verify not only product names but also ingredients, efficacy claims, and intended use.
If it complies with the Food Sanitation Act, there are no issues under the PMD Act	Even if safety is confirmed as food, advertising expressions may cause issues under the PMD Act.	Check for pharmaceutical-like efficacy claims in health foods and supplements.
If it can be imported as a cosmetic, any advertising use is allowed	Cosmetics have a limited scope of permissible efficacy claims on labels.	Pay attention to claims about treatment, inflammation improvement, hair growth, cell regeneration, etc.
If labeled for research use only, it is not an in vitro diagnostic drug	Even if labeled "Research Use Only," the intended use and advertising for domestic sales can change the classification.	Confirm target specimens, test purposes, sales destinations, and advertising expressions.
Products imported for personal use can be sold domestically	Personal import for self-use and import for commercial resale are different.	When selling, reselling, or distributing, confirm compliance with the PMD Act and other regulations.
If customs clearance is obtained, sales are permitted	Customs clearance and domestic sales are separate; labeling, advertising, permits, approvals, and notifications must be confirmed before sales.	Avoid sales before market release and advertisement confirmation are fully completed.
Freight forwarders will decide if imports are permissible	Freight forwarders are not the ultimate decision-makers under the PMD Act.	They facilitate confirmation by prompting checks on suspicious cargo and organizing documents to share with involved parties.
Losses due to stopping under the PMD Act are covered by marine cargo insurance	Sales restrictions due to non-compliance under the PMD Act are regulatory and sales management risks different from physical damage during transport.	Differently handle cargo incidents and regulatory non-compliance.

Practical Precautions

The PMD Act cannot be judged solely by product name or appearance.

Products sold overseas as food, cosmetics, miscellaneous goods, health devices, or research supplies may fall under the PMD Act in Japan.

Importers need to verify ingredients, efficacy claims, intended use, sales form, advertising expressions, import purpose, and required permits, approvals, notifications, and import confirmation certificates in advance.

Freight forwarders and customs brokers are not in a position to definitively determine whether the PMD Act applies. Instead, they should focus on early detection of questionable cargo, encourage importers to verify, and organize necessary documents before customs clearance.

It is important to note that risks under the PMD Act relate to regulatory and sales management issues rather than cargo accidents, and are not necessarily covered by marine cargo insurance.

Summary

The Pharmaceutical and Medical Device Act is a law designed to ensure the quality, efficacy, and safety of pharmaceuticals, quasi-drugs, cosmetics, medical devices, in vitro diagnostic drugs, and related products.

In import operations, the first critical step is to determine to which category the product belongs.

Key factors for borderline determinations include the ingredients, efficacy claims, intended use, form and method of use, and sales format.

Even health foods and supplements could be treated as unapproved pharmaceuticals if they claim pharmaceutical efficacy or effects without authorization.

Cosmetic products and measuring instruments may fall under cosmetics, quasi-drugs, or medical devices depending on their labeling and function.

Importers, customs brokers, and freight forwarders need to verify the applicable category under the PMD Act, required permits, approvals, or notifications, the necessity of import certificates, and advertising expressions before ordering or shipment.

The PMD Act is one of the most important laws in import sales operations, requiring checks not only at customs clearance but also for post-import sales labeling, advertising expressions, and safety management.