Medical Devices — PMD Act Procedures and Import Checks
Interlink編集部What Are Medical Devices
Medical devices are machines, instruments, etc., intended for use in the diagnosis, treatment, or prevention of diseases in humans or animals, or that affect the structure or function of the body.
Under the Pharmaceuticals and Medical Devices Act (PMD Act), medical devices are regulated products requiring assurance of quality, efficacy, and safety.
In import operations, items commonly sold overseas as general health equipment, beauty devices, measuring instruments, testing-related devices, nursing care products, apps, or software may still fall under the medical device category in Japan.
Judgment cannot be made by the product name alone; it is necessary to check the intended use, structure, performance, risk classification, labeling, advertising expressions, sales channels, and users.
Scope Covered in This Article
| Scope | Contents Organized in This Article | Aspects Requiring Separate Confirmation |
|---|---|---|
| Basics of Medical Devices | Organized as machines and instruments intended for diagnosing, treating, preventing diseases, or affecting body structure/functions. | The classification of individual products as medical devices should be confirmed based on use, structure, advertising, and sales methods. |
| Medical Device Applicability | Examines the potential for general goods, beauty devices, health devices, and measuring devices to qualify as medical devices. | If the determination is difficult, importers, regulatory affairs personnel, or administrative offices should be consulted. |
| Class Classification | Explains differences from Class I to IV, general medical devices, controlled medical devices, and highly controlled medical devices. | General names, class classification, and presence of certification criteria must be checked for each item. |
| Approval, Certification, and Notification | Outlines differences in procedures such as approval, certification, and notification for medical device categories. | Details on procedures, review documents, certification standards, and equivalence materials require separate expert confirmation. |
| Differences from In Vitro Diagnostic Drugs | Separates measuring instruments, reagents, cartridges, and test kits for clarification. | Reagents or diagnostic drugs using human-derived samples should be checked under the article on in vitro diagnostic drugs. |
| Program Medical Devices | Organizes the applicability of apps, cloud services, diagnostic support software, and image analysis software. | Consultations on standalone software applicability and approval, certification, notification require expert confirmation. |
| Freight Forwarder and Customs Practice | Lists checks when seeing cargo names like device, equipment, monitor, software, etc. | Freight forwarders do not make definitive judgments on medical device applicability or the necessity of permissions, registrations, or item procedures. |
Why Medical Devices Become an Issue
Medical devices represent an area where classification verification is especially critical under the PMD Act.
Even similar machines or instruments may be handled either as general goods or require confirmation as medical devices depending on intended use, labeling, advertising, usage of measurement results, and bodily effects.
For example, there is a difference in regulatory treatment between items sold purely as fitness goods, beauty devices, or health management machines versus those marketed for disease diagnosis, treatment, prevention, or improvement of body functions.
Importers must check not only how the product is sold overseas but also its intended sales, advertising, and usage purposes within Japan.
Purpose and Background of the System
Because medical devices relate directly to diagnosis, treatment, prevention, and effects on bodily functions, malfunctions or misuse can directly impact human health.
Therefore, medical devices require careful management of quality, efficacy, safety, risk classification, manufacturing and sales responsibilities, item-specific approval, certification or notification, labeling, advertising, and post-market safety surveillance.
Products categorized overseas as general goods, health devices, beauty devices, research instruments, or apps may require confirmation as medical devices when marketed for medical purposes in Japan or when measurement results are used for diagnosis, treatment, or prevention.
In import practice, it is necessary to confirm not only customs clearance but also whether the classification, procedures, labeling, and advertising meet requirements for domestic sales, rental, or business use.
Products Subject to This
Products potentially subject to the medical device category include not only equipment used in medical settings but also home use, health management, beauty-related, and nursing care products.
| Product Examples | Main Uses | Points to Confirm | Notes |
|---|---|---|---|
| Blood pressure monitors, thermometers, pulse oximeters | Used to monitor physical condition and measurements. | Generic name, classification, certification/notification, labeling, sales channels | Even if they appear as health management products, they may qualify as medical devices. |
| Contact lenses, hearing aids | Used for vision or hearing correction and assistance. | High-level control medical device status, sales management, approval/certification | They may not always be handled as general goods or beauty products. |
| Syringes, catheters, surgical instruments | Used for medical procedures, treatments, and surgeries. | Classification, sterilization, approval/certification/notification, sales channels | Document verification is crucial when importing for medical institutions. |
| Imaging diagnostic devices, ultrasound diagnostic devices, testing devices | Used for diagnosis, testing, measurement, and image acquisition. | Intended use, performance, classification, approval/certification, software | Confirm devices, reagents, and software separately. |
| Treatment devices, rehabilitation equipment | Used for treatment, functional recovery, and rehabilitation. | Treatment purpose, effects on the body, sales channels, advertising expressions | Expressions like "improvement" or "treatment" may affect medical device classification. |
| Home-use beauty and health devices | May be sold for beauty, relaxation, and health management purposes. | EMS, light, ultrasound, thermal, low-frequency, advertising expressions | If claimed for medical purposes or bodily function improvement, medical device confirmation is needed. |
| Apps, cloud services, diagnostic support software | May be used for analysis of measurement data, image analysis, diagnostic support, risk assessment. | Program medical device applicability, intended use, judgment functions, advertising | Even without physical goods, confirmation under pharmaceutical law may be required. |
List of Regulation Application Scenarios
| Scenario | Reason Why Regulation May Apply | Documents to Confirm | Common Causes of Delays |
|---|---|---|---|
| Importing and selling overseas health devices | Though appearing as health appliances, if claimed for diagnosis, treatment, prevention, or bodily function effects, they may qualify as medical devices. | Product catalogs, specifications, advertisements, usage explanations | Making decisions solely based on overseas sales as "wellness devices." |
| Selling to medical institutions or nursing care facilities | Users or sales destinations are close to medical applications; medical device classification or item procedures may become issues. | Sales destination documents, intended use, manuals, approval/certification/notification documents | Planning to sell to medical institutions after importing as general goods. |
| Using measurement results for diagnosis or treatment decisions | Needs confirmation as devices used for medical decisions, not just measurement instruments. | Measurement items, result display, usage instructions, advertisements, sales materials | Only verifying measurability without checking how results are used. |
| Beauty devices claiming bodily effects | Effects like EMS, low-frequency, light, ultrasound, thermal, and advertising claims become issues. | Specifications, SDS, advertisements, usage instructions, overseas labels | Translating overseas advertisements literally into Japanese for sales. |
| Importing testing devices together with reagents | Device bodies are medical devices, while reagents or cartridges may qualify as in vitro diagnostic drugs. | Device specifications, reagent materials, software specifications, intended uses | Treating the whole set simply as a testing kit. |
| Providing apps or software | If performing diagnostic support, treatment support, image analysis, or risk assessment, program medical devices become relevant. | Software specifications, judgment logic, advertisements, terms of use | Missing pharmaceutical law confirmations because no physical goods are involved. |
| Selling or reselling personally imported items | Imports for self-use and those for commercial purposes differ; pharmaceutical law procedures need checking for sales. | Quantities, sales destinations, e-commerce listings, order history, usage explanations | Selling items obtained through personal imports domestically. |
Medical Device Classification
Medical devices are classified according to the risk they pose to the human body.
Based on this classification, devices are categorized into general medical devices, controlled medical devices, and highly controlled medical devices, which affects notification, certification, and approval procedures per item.
| Category | Risk Perspective | Pharmaceutical and Medical Device Act Classification | Main Procedures | Examples |
|---|---|---|---|---|
| Class I | The risk to the human body is extremely low even if a malfunction occurs. | General Medical Devices | Notification | Small steel items, X-ray films, dental technician supplies, etc. |
| Class II | The risk to the human body is relatively low even if a malfunction occurs. | Controlled Medical Devices | Certification or Approval | Electronic blood pressure monitors, electronic endoscopes, ultrasound diagnostic devices, etc. |
| Class III | There is a relatively high risk to the human body if a malfunction occurs. | Highly Controlled Medical Devices | Approval or Certification | Ventilators, dialysis machines, balloon catheters, etc. |
| Class IV | Highly invasive to patients, with potential life-threatening risk in case of malfunction. | Highly Controlled Medical Devices | Approval | Pacemakers, artificial heart valves, stents, etc. |
Importers need to confirm not only whether the product qualifies as a medical device but also which class it falls under.
Mistaken classification can lead to errors in required approval, certification, notification, manufacturing and sales licensing categories, or sales management systems.
Differences Between Approval, Certification, and Notification
For medical devices, procedures by item include approval, certification, and notification.
Generally, notification is the main procedure for low-risk general medical devices, certification or approval is common for controlled medical devices, and approval is mainly required for highly controlled medical devices.
However, the actual procedure varies based on the general name, classification, presence of certification standards, intended use, structure, performance, and equivalence to existing products.
| Procedure | Main Targets | Main Confirmation Items | Practical Notes |
|---|---|---|---|
| Notification | Primarily general medical devices | Trade name, generic name, shape, structure, intended use, manufacturer, etc. | Being subject to notification does not exempt the need for manufacturing and sales licenses or manufacturing registration. |
| Certification | Controlled medical devices with certification standards, etc. | Compliance with certification standards, performance, safety, quality control system | If certification standards are not met, approval may be required. |
| Approval | Highly controlled medical devices, new medical devices, controlled medical devices without certification standards, etc. | Quality, effectiveness, safety, clinical evaluation, performance evaluation, etc. | Review periods and documentation demands are significant, impacting import and sales plans. |
Importers should not assume that approval, certification, or notification in Japan can be omitted just because the product is already marketed overseas.
Comparison with Other Systems and Similar Products
| Category | Main Meaning | Differences from Medical Devices | Documents to Confirm | Practical Notes |
|---|---|---|---|---|
| Medical Devices | Equipment and instruments intended for diagnosis, treatment, prevention of diseases, or affecting body structure or functions. | Focus on device body, structure, performance, intended use, and body effects. | Specifications, intended use, generic name, classification, item procedure documents | Check intended use and advertising in Japan rather than product name. |
| In Vitro Diagnostic Drugs | Reagents or test kits used for testing/measurement of human-derived samples outside the body. | Focus on reagents, reaction solutions, cartridges, confirmed separately from the device body. | Target samples, reagent manuals, test items, approval/certification/notification documents | When importing test devices and reagents as a set, confirm separately. |
| Program Medical Devices | Programs intended for diagnosis, treatment, prevention, etc. | Rather than physical devices, software or apps may qualify as medical devices in some cases. | Software specifications, diagnostic function, advertising, terms of use | Pharmaceutical and Medical Device Act confirmation may be required even without physical goods. |
| Cosmetics and Beauty Devices | Products intended for beauty, cleanliness, beautification, or appearance care. | If disease treatment or body function improvement is claimed, it may approach medical device status. | Advertising, usage instructions, specifications, description of body effects | Confirm overall advertising to determine if for beauty or medical purposes. |
| Health Equipment and Fitness Products | General goods intended for exercise, health management, or relaxation. | If claims include treatment, prevention, pain relief, or blood flow improvement, medical device applicability becomes an issue. | Product descriptions, advertising, measurement results, sales destinations | Do not judge solely based on terms like "health monitor" or "wellness device." |
| General Goods and Sundries | General machinery and household items that do not claim medical purposes. | If there are no medical, body effect, diagnostic, treatment, or prevention claims, it falls outside medical devices. | Usage explanations, sales materials, advertising, user manuals | Be cautious of advertising changes post-sale that may involve medical device-like expressions. |
Main Procedures in Import and Sales
When importing and selling medical devices for commercial purposes, confirmation of medical device manufacturing and sales licenses, manufacturing registrations, and foreign manufacturer registrations is required.
In addition, approval, certification, or notification may be required for each item.
Which procedures are necessary depends on the classification, risk category, intended use, sales method, and whether storage, labeling, or packaging operations are conducted domestically.
| Check Items | Main Content | Common Causes for Delays |
|---|---|---|
| Medical Device Applicability | Confirm whether the product corresponds to a medical device, in vitro diagnostic drug, general product, cosmetic, etc. | This occurs when the product is judged solely by being sold as a general product overseas. |
| Class Classification | Check whether it falls under Class I to IV, general medical device, controlled medical device, or highly controlled medical device. | Procedural classification errors caused by failing to confirm general name or intended use. |
| Manufacturing and Marketing Approval | Confirm the approval of the responsible entity for market shipment within Japan. | Where the importer considers themselves just a seller and has not designated a manufacturing and marketing authorization holder. |
| Manufacturing Registration | Confirm manufacturing sites performing storage, packaging, labeling, or pre-shipment inspection within Japan. | When the need for registration is not checked despite warehouse activities like label application and storage. |
| Foreign Manufacturer Registration | Check whether registration of overseas manufacturing sites is required and obtain manufacturing site information. | When manufacturing site information cannot be obtained from the overseas manufacturer. |
| Product Procedure | Confirm whether approval, certification, or notification is necessary. | Misunderstanding that Japan's procedures can be omitted because the product is already approved overseas. |
| Labeling & Advertising | Check attached documents, labels, instruction manuals, and advertising expressions. | When claims exceed the approved, certified, or notified scope of the medical device. |
Differences from In Vitro Diagnostic Drugs
Medical devices and in vitro diagnostic drugs are areas commonly confused in import operations.
Medical devices refer to machinery and instruments intended for the diagnosis, treatment, prevention of disease, or for affecting the structure or functions of the body.
In vitro diagnostic drugs are reagents and test kits used for inspection and measurement outside the body, using samples derived from human blood, urine, tissues, secretions, etc.
When importing testing equipment and dedicated reagents as a set, the measuring device itself is considered a medical device, while reagents and cartridges may be classified as in vitro diagnostic drugs and require separate confirmation.
If software or apps that process test results are included, the relationship with program medical devices should also be checked.
Borderline with Home-use Beauty and Health Devices
Home-use beauty and health devices frequently raise questions regarding their applicability as medical devices.
Even if sold overseas as beauty devices, wellness devices, or health equipment, if marketed in Japan with claims related to disease treatment, prevention, improvement, or bodily function effects, they may require confirmation as medical devices.
Devices utilizing EMS, electrical stimulation, heat, light, lasers, ultrasound, suction, vibration, low frequency, or high frequency demand particular attention to their labeling and advertising expressions.
For example, expressions like "relieves stiff shoulders," "improves blood flow," "breaks down fat," "has therapeutic effects," "relieves pain," or "has medical-level efficacy" could be problematic as medical device claims.
Conversely, even claims limited to beauty, relaxation, general hygiene, or cosmetic care may require careful review depending on the device’s structure and action.
Relation to Program Medical Devices
Program medical devices are defined as programs intended for diagnosing, treating, or preventing disease, etc., where malfunction could impact human life or health.
In import operations, this includes not only physical devices but also apps, cloud services, image analysis software, diagnostic support software, and data analysis programs.
For example, software that analyzes medical images to highlight lesion candidates, apps that provide diagnostic support based on measured data, or decision support programs related to treatment policies require medical device applicability review.
Even general health recording or fitness management apps require caution if they claim to diagnose, treat, or prevent diseases.
Differences Between Personal Import and Commercial Purpose Import
In medical devices, it is important to distinguish between personal use imports and imports for commercial sale or distribution.
Regulations differ whether the import is for personal use within specified limits or for sales, leasing, business use, or delivery to medical institutions within Japan.
Medical devices obtained by personal import cannot be sold, resold, or distributed domestically.
For commercial import and sale, approval for manufacturing and marketing authorization, manufacturing registration, foreign manufacturer registration, product-specific approval/certification/notification, and labeling/advertising compliance must be confirmed.
System Application Flow
- Check not just the product name, but also purpose of use, structure, performance, labeling, advertising, sales destination, and user.
- Confirm whether the product is intended for diagnosis, treatment, prevention, or affecting the structure or function of the body.
- Classify whether the product may be a medical device, in vitro diagnostic drug, program medical device, general product, or beauty device.
- If potentially a medical device, confirm its general name and class classification.
- Confirm classification into general medical device, controlled medical device, or highly controlled medical device.
- Check which among approval, certification, or notification is required for each product.
- Confirm the manufacturing and marketing authorization holder responsible for market shipment within Japan.
- If storage, packaging, labeling, etc., occur domestically, confirm whether manufacturing registration is required.
- If overseas manufacturing sites are involved, confirm foreign manufacturer registration requirements.
- Review attached documents, labels, user manuals, advertising, e-commerce sites, and SNS expressions.
- Before customs clearance, confirm with importer, customs broker, pharmaceutical affairs personnel, and specialists as needed.
Import Operation Flow
| Stage | Main Points to Check | Common Causes of Delays |
|---|---|---|
| Before Procurement | Check intended use, effects, structure, performance, sales destinations, and advertising expressions. | When the product is sold as a general item overseas and is therefore judged as not regulated in Japan. |
| Classification Confirmation | Confirm medical device applicability, generic name, class classification, and distinction from in vitro diagnostic drugs. | When decisions are made only based on product names without verifying intended use or how measurement results will be used. |
| Permit and Registration Confirmation | Check manufacturing and sales business licenses, manufacturing registration, and foreign manufacturer registration. | When responsibility for market shipment is unclear or undecided. |
| Commodity Procedure Confirmation | Confirm whether approval, certification, or notification is required. | When it is found after import arrangements that commodity procedures are incomplete. |
| Customs Declaration | Organize information on use, permits/registration, approvals/certifications/notifications, and product documentation. | When invoices simply list items as "device" or "equipment" and intended use is unclear. |
| Domestic Storage and Labeling | Check labels, inserts, instruction manuals, storage locations, and manufacturing registrations. | When registration requirements are not checked before conducting labeling work at domestic warehouses. |
| Before Sales Start | Check advertising expressions, sales destinations, loaning, and explanatory materials for medical institutions. | When advertising exceeds the scope of approved certifications and notifications regarding effects and uses. |
Common Problematic Cases in Import Operations
| Case | What Becomes an Issue | Documents to Check | Practical Actions |
|---|---|---|---|
| Importing overseas health devices as general goods | When claims involve medical purposes or improvement of bodily functions, medical device applicability may be an issue. | Product catalogs, advertisements, specifications, intended use | Confirm Japan-targeted advertisements and intended use. |
| Household beauty devices sold with expressions close to medical devices | Actions such as EMS, light, ultrasound, low frequency, and medical expressions may cause issues. | Overseas advertisements, specifications, instruction manuals, sales pages | Clarify whether expressions are limited to beauty purposes or if medical device confirmation is required. |
| Importing inspection equipment together with reagents | Regulatory categories may differ between the device, reagents, and software. | Device specifications, reagent documents, software specifications, test items | Confirm medical device and in vitro diagnostic drug status for each component. |
| Providing apps or cloud services | If providing diagnostic support, treatment support, or image analysis, program medical devices may be involved. | Software specifications, decision logic, terms of use, advertisements | Check applicability to pharmaceutical affairs law even without physical goods. |
| Domestic sales of individually imported products | Confusion arises between self-use import and commercial import purposes. | Quantities, sales destinations, EC listing information, order history | Confirm permits, registrations, and commodity procedures as commercial import. |
| Sales to medical institutions without confirming commodity procedures | If sales destination is a medical institution, medical device applicability and approvals/certifications/notifications may be issues. | Sales destination documents, approval/certification/notification documents, inserts | Confirm procedural status as medical device. |
| Omitting Japanese procedures because of overseas approvals | Even if sold and approved overseas, Japanese procedures may still be required. | Overseas approval documents, Japan generic names, class classification documents | Verify classifications and procedures under Japan's pharmaceutical affairs law. |
| Conducting labeling work at domestic warehouses | Manufacturing registration may be involved in storage, packaging, labeling, and label affixing. | Warehouse information, work contents, registration documents, outsourcing contract | Confirm whether logistics tasks or pharmaceutical manufacturing acts under the law are involved. |
Notes on Labeling and Advertising
Even general products that do not qualify as medical devices may cause issues if they claim to diagnose, treat, prevent diseases, or improve body functions as medical device-like effects or benefits.
It is necessary to check labels, instruction manuals, inserts, EC sites, brochures, social media, advertising text, and video explanations for any expressions indicating medical purposes.
Also, even approved, certified, or notified medical devices may encounter issues if advertisements promote effects or uses beyond the approved scope.
Importers need to check not only before import but also sales pages, advertisements, sales materials, and materials aimed at medical institutions.
Points for Freight Forwarders and Customs Practice
Freight forwarders and customs personnel must confirm whether items labeled as "machine," "device," "medical equipment," "health equipment," "beauty device," "monitor," "sensor," "software," etc., have medical device applicability.
Freight forwarders are not in a position to make final determinations regarding medical device applicability or the need for permits, registrations, or commodity procedures under pharmaceutical affairs law.
However, if the cargo name, product description, sales materials, or intended use suggests the need for confirmation under the pharmaceutical affairs law, they should encourage importers to verify and share information with customs brokers promptly.
If customs inquiries arise, freight forwarders should collect from importers intended use explanations, product catalogs, specifications, instruction manuals, approval/certification/notification materials, and permit/registration documents and coordinate with customs brokers.
Freight forwarders should avoid definitively stating, "It's a health device, so there is no problem," or "It is not a medical device."
Scope of Freight Forwarders' Involvement
| Scenario | What Support Can Be Provided | What Should Not Be Concluded | Practical Response |
|---|---|---|---|
| When "device" or "equipment" appears in the cargo name | You can prompt the importer to confirm the intended use, sales purpose, end user, and sales destination. | Do not conclusively state that it is not a medical device or that it is a general product. | Share product documentation with the customs broker as early as possible. |
| When it is identified as cargo for medical institutions | You can encourage confirmation of approval, certification, notifications, permits, and registration documents with the importer. | Do not independently conclude that it is exempt from regulation even if intended for medical institutions. | Request confirmation from the importer's regulatory affairs representative. |
| When importing beauty or health devices | You can encourage checking whether there are any medical claims or indications in advertising expressions or usage purposes. | Do not conclusively state that because it is a beauty device, it is not a medical device. | Request confirmation before using Japanese in overseas advertisements. |
| When inspection equipment, reagents, and software come as a set | You can encourage organizing documentation for each component. | Do not conclude that the set is a general product or a simple test kit. | Check equipment, reagents, and software separately. |
| When customs confirmation is requested | You can collect explanations of use, specifications, and approval, certification, and notification documents from the importer. | Freight forwarders should not respond that no permits or procedures are required. | Connect the importer, customs broker, and regulatory affairs personnel. |
| When it is unclear whether it is personal import or commercial purpose | You can encourage checking quantities, delivery destinations, planned sales, and repetition. | Do not readily treat it as for personal use. | If there is a sales purpose, organize it as a commercial import. |
Required Documentation
| Document | Content to Confirm | Purpose in Practical Logistics |
|---|---|---|
| Product Catalog | Product overview, usage, effects, sales destination | Used to verify if the product qualifies as a medical device. |
| Specification Sheet | Structure, performance, function, measurement items, electrical specifications | Used to confirm classification and usage purposes. |
| User Manual / Accompanying Documents | Usage method, intended use, contraindications, precautions, labeling content | Confirm consistency with approval, certification, and notification scope. |
| Usage Purpose Explanation Documents | Diagnosis, treatment, prevention, impacts on body functions | Material for medical device qualification judgment. |
| Sales Destination / End User Explanation Documents | Classification such as medical institutions, nursing care facilities, general consumers, research institutions | Check sales form and required procedures. |
| Approval, Certification, Notification Related Documents | Procedure status by item, sales name, generic name | Confirm whether the product can be sold in Japan. |
| Medical Device Manufacturing and Marketing Business License / Manufacturing Registration Documents | Market shipment responsible person, domestic operation location, registration status | Verify import and sales system. |
| Foreign Manufacturer Registration Documents | Overseas manufacturing site, location, manufacturing range | Used to confirm import procedures from overseas manufacturers. |
| Software Specification Sheet | Decision functions, analysis functions, risk display, diagnostic support functions | Verify the qualification as program-based medical devices. |
| Invoice / Packing List | Item names, quantities, prices, importer, cargo details | Cross-check customs declaration info with Pharmaceuticals and Medical Devices Act documentation. |
4-Column Decision Checklist
| Confirmation Scenario | Party to Confirm With | Items to Confirm | Action if Issues Are Found |
|---|---|---|---|
| At procurement consideration | Importer, overseas manufacturer | Intended use, structure, performance, classification in sales country, advertising expressions | If medical purpose expressions exist, conduct regulatory review. |
| When verifying medical device qualification | Importer, regulatory affairs personnel | Diagnosis, treatment, prevention, effects on body functions | If qualification is unclear, consult experts or government agencies. |
| When confirming class classification | Importer, regulatory affairs personnel, overseas manufacturer | Generic name, Class I–IV, categories of general, controlled, and highly controlled medical devices | Do not proceed with import arrangements while classification is unclear. |
| When confirming item procedures | Marketing authorization holder, regulatory affairs personnel | Whether approval, certification, or notification is required | If incomplete, confirm procedure status before market shipment. |
| At customs declaration | Customs broker, importer | Explain usage, approval/certification/notification documents, permit/registration documents, product documentation | Avoid declaring with ambiguous cargo names like "device" alone. |
| During domestic storage and labeling | Importer, warehouse, manufacturer | Labeling, packaging, storage, label affixing, need for manufacturing registration | Confirm if domestic operation registration is required. |
| When preparing advertising materials | Importer, advertising staff, regulatory & legal personnel | Effects/efficacy, medical purpose, scope of approval/certification/notification, social media expressions | Adjust to avoid over-claiming medical device effects. |
| When confirming personal import status | Importer, consignee, customs broker | Whether for personal use, or for sales, resale, lending, or business use | If sales purpose exists, organize as commercial import. |
Practical Scenario 1: Attempting to Import Overseas Health Devices as General Products
There are cases where importers procure health management devices sold overseas and plan to sell them via e-commerce within Japan.
These devices are marketed overseas as wellness devices, but the product descriptions include expressions such as "improves blood circulation," "relieves pain," and "therapeutic effects."
In such cases, the status of these products as medical devices or their medical device-like efficacy might become an issue in Japan.
Importers need to check not only the product name but also the intended use, structure, physiological effects, and advertising expressions.
Practical Scenario 2: Home Beauty Devices Sold with Medical Device-like Claims
There are cases where importers bring in EMS facial devices or light-based beauty devices.
These are planned to be sold for beauty purposes; however, the overseas product pages contain expressions such as "muscle treatment," "inflammation improvement," "fat decomposition," and "medical grade."
Directly translating and selling these descriptions in Japanese might lead to issues related to medical device-like efficacy.
Importers need to clarify whether to limit the advertising to expressions suitable for general cosmetic devices in Japan or to verify if the product should be treated as a medical device.
Practical Scenario 3: Importing Inspection Devices with Reagents as a Set
Importers may bring in compact inspection devices together with dedicated reagents from overseas manufacturers as a set.
The measurement device itself may be classified as a medical device, while the dedicated reagents or cartridges could fall under in vitro diagnostic drugs.
Additionally, if software that analyzes inspection results is included, it may be necessary to check its relationship to program medical devices.
Importers should not treat the device, reagents, and software collectively as a "test kit" but confirm each item's classification under the Pharmaceutical and Medical Device Act and the necessary procedures.
Practical Scenario 4: Selling Medical Device Software as an App
Importers or domestic sellers might provide apps or cloud services developed overseas in Japan.
If it is merely a health record app, it may not qualify as a medical device; however, if the app performs diagnosis support, treatment policy decisions, medical image analysis, or risk assessment, it may need to be confirmed as program medical device.
Even when there is no physical cargo, the question of medical device applicability under the Pharmaceutical and Medical Device Act could arise.
In import operations, it is necessary to check not only the physical device itself but also software, cloud functions, decision algorithms, and advertising expressions.
Practical Scenario 5: Redirecting Personal Imports for Domestic Sales
There are cases in which individuals purchase medical or health devices from overseas e-commerce sites and later attempt to sell them domestically in Japan.
Personal imports for self-use and imports for commercial sales are treated separately.
When intended for domestic sale, resale, lending, or business use, issues arise concerning medical device manufacturing and sales licenses, manufacturing registration, foreign manufacturer registration, item-specific approvals, certifications, notifications, and advertising compliance.
Freight forwarders and customs personnel should prompt importers to verify if there are irregularities in quantity, repeat frequency, sales purpose, delivery destination, or product description.
Impacts of Customs Clearance or Sales Being Stopped
If goods potentially classified as medical devices are subject to scrutiny, delays in customs clearance, storage charges, delivery delays, postponement of sales commencement, and delayed delivery to medical or nursing facilities may occur.
If the necessary manufacturing and sales licenses, manufacturing registration, foreign manufacturer registration, approvals, certifications, or notifications are not confirmed, it may not be possible to sell the imported products.
Furthermore, if the sales page or advertising raises issues under the Pharmaceutical and Medical Device Act, it is possible to face objections at the stage of domestic sales or advertising even after customs clearance.
Importers need to check not only customs clearance but also post-import storage, labeling, advertising, sales destinations, and intended use in advance.
Division of Roles with the Article on Medical Device Manufacturing and Sales Licenses
The "Medical Device" article organizes definitions, classification classes, medical device applicability, boundaries with home cosmetic devices, differences from in vitro diagnostic drugs, and program medical devices.
In contrast, the "Medical Device Manufacturing and Sales License" article specializes in the manufacturing and sales licenses, manufacturing registrations, foreign manufacturer registrations, approvals, certifications, notifications, and the accountability aspects necessary for importing and selling medical devices.
In practice, first confirm whether the product qualifies as a medical device and its classification using this article, then check the specific licensing, registration, and item procedures in the "Medical Device Manufacturing and Sales License" article.
Common Misunderstandings
| Misunderstanding | Correct Understanding | Practical Notes |
|---|---|---|
| If it's a wellness device overseas, it is a general product in Japan as well | Overseas classification and Japan’s Pharmaceutical and Medical Device Act classification are separate. | Check the purpose of use, advertising, and sales destinations in Japan. |
| If not sold to medical institutions, it is not a medical device | Even products for general consumers may fall under medical devices if intended for diagnosis, treatment, or prevention. | Confirm not only the sales target but also the intended use. |
| If it is a beauty device, it is not a medical device | Even beauty devices require confirmation if they claim to improve body functions or have therapeutic effects. | Review the mechanisms and advertisements involving EMS, light, ultrasound, low frequency, etc. |
| If approved overseas, it can be sold in Japan | Overseas approval and Japanese approval, certification, notification are distinct. | Check the Japanese generic name, class classification, and item procedures. |
| Apps are not cargo and thus unrelated to the Pharmaceutical and Medical Device Act | Programs supporting diagnosis or treatment can raise medical device applicability issues. | Check software specifications and advertising expressions. |
| If it is a notification target, permission or registration is not required | Item notification is separate from manufacturing and sales permission or manufacturing registration. | Distinguish and confirm item procedures from business permits and registrations. |
| A freight forwarder can just describe it as health equipment | Freight forwarders are not in a position to determine medical device applicability. | Collect usage explanations and pharmaceutical compliance documentation from the importer. |
| Clearing customs means sales are unrestricted | Customs clearance and domestic sales, advertising, market shipment are separate checks. | Confirm permits, registrations, item procedures, and advertising before sales start. |
Practical Notes
Medical devices are an area where errors in Pharmaceutical and Medical Device Act compliance can cause significant issues in customs clearance and domestic sales.
For import and sales, judgment should not be based solely on the product name; it is necessary to check the use, performance, labeling, advertising expressions, sales purpose, user, and sales destination.
Particular care is needed to confirm medical device applicability for health equipment, beauty devices, measuring devices, testing equipment, programs, apps, and nursing care-related devices.
Freight forwarders are not decision-makers under the Pharmaceutical and Medical Device Act, but when seeing cargo names like device, medical equipment, health equipment, beauty device, monitor, sensor, software, etc., they should confirm with the importer and share information with customs brokers.
Summary
Medical devices are machines and instruments intended for diagnosing, treating, or preventing diseases in humans or animals, or for affecting body structure or functions.
In import operations, products sold overseas as general goods, health equipment, beauty devices, measuring devices, or apps may still be considered medical devices in Japan.
For medical devices, it is necessary to confirm the class classification, the distinctions between general medical devices, controlled medical devices, and highly controlled medical devices, approval, certification, notification, manufacturing and sales permits, manufacturing registration, and foreign manufacturer registration.
Freight forwarders are not responsible for judging medical device status, but for cargo with doubts, they should encourage confirmation from the importer and share information with customs brokers.
Medical devices connect use purpose, risk classification, item procedures, labeling, advertising, and sales destination directly to customs clearance and domestic sales. Pre-import pharmaceutical compliance and classification checks are the most critical preventive measures.
