In Vitro Diagnostics (IVD) — Import Procedures and PMD Act Checks
Interlink編集部What Are In Vitro Diagnostic Pharmaceuticals
In vitro diagnostic pharmaceuticals are regulated products under the Pharmaceuticals and Medical Devices Act that use human-derived specimens such as blood, urine, tissues, and secretions to diagnose diseases, assess health conditions, or measure test items.
Unlike pharmaceuticals administered directly to the human body, these mainly include reagents, test kits, and diagnostic drugs used to test and measure specimens taken from the body outside the human body.
In import practice, even products sold overseas as "research use only," "laboratory reagent," "test kit," "diagnostic reagent," or "self check kit" may fall under in vitro diagnostic pharmaceuticals in Japan if they are intended or sold for diagnosis, testing, judgment, or health assessment purposes within the country.
Therefore, it is essential to confirm not only whether the product name is reagent or test kit but also its intended use, labeling content, sales destination, test items, use of human-derived specimens, and domestic sales methods.
Scope Covered in This Article
| Scope | Content Covered in This Article | Matters to be Confirmed Separately |
|---|---|---|
| Basics of In Vitro Diagnostic Pharmaceuticals | Organized as reagents or diagnostic drugs used with human-derived specimens for diagnosing diseases and evaluating health conditions. | Final applicability under the Pharmaceuticals and Medical Devices Act, and the necessity of approval, certification, or notification should be confirmed with experts or relevant authorities. |
| Difference From Research Reagents | Differences between reagents for research/experimental purposes and those for diagnosis, testing, or judgment are organized. | Requires verification of individual product labeling, sales methods, advertising, and actual usage purposes. |
| Difference From Medical Devices | Separates measurement devices, software, reagents, and cartridges for explanation. | Regulations on medical devices, program medical devices, and measurement apparatus bodies should be checked separately. |
| Import Sales Procedures | Organizes manufacturing and sales permits, manufacturer registrations, foreign manufacturer registrations, and item-specific approvals, certifications, and notifications. | Classification by item, generic names, class categories, and procedure details require pharmaceutical regulatory confirmation. |
| Labeling and Advertising | Organizes expressions related to test items, intended uses, disease names, judgments, and health condition evaluations. | Advertising reviews, sales pages, SNS expressions, and appropriateness of attached documents should be confirmed by specialists. |
| Customs Clearance and Forwarder Practice | Organizes points to check when seeing cargo names such as test kit, diagnostic reagent, and laboratory reagent. | Freight forwarders should refrain from final judgments on applicability under the Pharmaceuticals and Medical Devices Act and encourage confirmation with importers or customs brokers. |
| Exclusions and Separation From Other Systems | Organizes differences from research reagents, miscellaneous goods, medical devices, pharmaceuticals, health foods, and cosmetics. | Applicability for each product needs individual assessment based on ingredients, usage, advertising, sales destinations, and labeling content. |
Overview
In vitro diagnostic pharmaceuticals are used to test specimens taken from the human body outside the body.
Commonly distributed as test kits, diagnostic drugs, measurement reagents, diagnostic reagents, or judgment kits.
The regulatory requirements to be confirmed can vary depending on sales destinations or usage scenarios, such as medical institutions, testing laboratories, pharmacies, general consumers, or research institutions.
Even with the same reagent or kit, the classification under the Pharmaceuticals and Medical Devices Act may differ depending on whether it is used for research, diagnostic purposes, self-assessment by general consumers, or clinical and inspection use by medical or testing institutions.
Purpose and Background of the System
Because test results from in vitro diagnostic pharmaceuticals affect disease diagnosis, treatment plans, medical consultation decisions, and health evaluations, managing product quality, efficacy, safety, labeling, and intended use is crucial.
Although reagents and diagnostic kits are not used directly on the human body, incorrect test results or inappropriate labeling could lead to misdiagnosis, delayed medical visits, unnecessary anxiety, or incorrect self-judgments.
Therefore, under the Pharmaceuticals and Medical Devices Act, it is necessary to confirm manufacturing and marketing authorization holders, manufacturers, foreign manufacturers, approvals, certifications, notifications by item, attached documents, labeling, and advertising requirements.
In import practice, even if overseas manufacturers sell products as "for research," "for testing," or "simple kits," when these are sold in Japan with purposes of diagnosis, judgment, or health condition assessment, separate confirmation of the Japanese pharmaceutical regulatory classification is needed.
Products Subject to This Category
Products that may fall under in vitro diagnostic pharmaceuticals include those intended for testing diseases or physical conditions.
| Example Products | Examples of Intended Use | Points to Confirm | Notes |
|---|---|---|---|
| Infectious Disease Test Kits | Detection of infection status, antigens, antibodies, pathogens | Target diseases, target specimens, judgment methods, whether for general or medical institution use | Even if sold overseas, it is not guaranteed that they can be sold the same way in Japan. |
| Pregnancy Tests / Ovulation Tests | Judgment related to pregnancy and ovulation using urine or similar | Whether approved for general use, labeling, usage instructions, judgment methods | For general consumers, the instruction manual and cautions for false judgments are important. |
| Blood Glucose, Lipid, Urine Component Measurement Reagents | Measurement of physical condition and test items via blood, urine, etc. | Main measuring device, dedicated reagents, users, sales destinations | There may be both medical devices and in vitro diagnostic drugs involved. |
| Tumor Marker, Hormone, Antibody Test Reagents | Tests related to disease risk, diagnostic support, treatment decision-making | Intended use, target disease, for medical institutions or testing facilities | If related to diagnosis or treatment decisions, specialized Pharmaceutical Affairs confirmation is required. |
| Diagnostic Reagents for Medical or Testing Institutions | Clinical testing, diagnostic support, laboratory measurement | Generic names, approvals/certifications/notifications, package inserts | Whether it can be imported as research reagents depends on the use. |
| Simple Test Kits for General Consumers | At-home testing, self-checks, health condition verification | Suitability for general use, advertising claims, sales methods | Expressions such as "diagnosis at home" require careful confirmation. |
| Dedicated Cartridges, Reaction Solutions, Test Papers | Tests and judgments combined with measurement devices | Classification of main device, reagents, software | Accessories and consumables may also correspond to in vitro diagnostic drugs. |
Situations Where Regulations Apply
| Situation | Reason Regulations Become an Issue | Materials to Confirm | Common Reasons for Delays |
|---|---|---|---|
| Importing Test Kits from Overseas | If used in Japan for diagnosis, testing, or judgment, they may correspond to in vitro diagnostic drugs. | Product catalogs, intended use, target specimens, sales materials | Judging as research use or sundries solely based on overseas manufacturer descriptions. |
| Importing as Research Reagents | Even if labeled for research use, presenting diagnostic use during domestic sales may cause regulatory issues under the Pharmaceuticals and Medical Devices Act. | RUO labeling, sales pages, advertising text, sales destination materials | Discrepancies between explanations at import and domestic sales labeling. |
| Sales to General Consumers | Because used for self-judgment, suitability for general use, labeling, and advertising are crucial. | Package inserts, usage instructions, e-commerce pages, advertising text | Use of expressions that exceed approved scope, such as "can diagnose at home." |
| Sales to Medical and Testing Institutions | Used for clinical testing and diagnostic support, so product procedures and intended use confirmation are required. | Approval and certification documents, package inserts, explanations to sales destinations | Substantive circulation of research reagents as diagnostic-use products. |
| Importing Testing Devices and Dedicated Reagents as a Set | The main device may be classified as a medical device, while dedicated reagents may correspond to in vitro diagnostic drugs. | Device specifications, reagent manuals, software documents | Treating as a single complete product without confirming each classification. |
| Labeling, repackaging, and packaging conducted domestically | Manufacturing registration and labeling/packaging management may become issues. | Details of operations, storage locations, Japanese labeling, packaging specifications | Assuming domestic post-import operations are mere logistics tasks. |
| Advertising or Promoting Test Effectiveness on SNS | Expressions about diagnosis, judgment, disease names, or health evaluations may cause issues under the Pharmaceuticals and Medical Devices Act. | Advertising copy, landing pages, SNS posts, videos, brochures | Using efficacy claims that exceed the scope of approvals, certifications, or notifications. |
Differences from Medical Devices
Medical devices are machinery or instruments intended for diagnosing, treating, preventing diseases, or affecting the body’s structure or functions.
In contrast, in vitro diagnostic drugs mainly consist of reagents and kits used for testing and measuring using body-derived specimens.
However, when testing devices, measuring instruments, reagents, cartridges, and software are combined, verification of both medical device and in vitro diagnostic drug classifications may be necessary.
For example, the measuring device itself could be classified as a medical device, while dedicated reagents or cartridges are categorized as in vitro diagnostic drugs.
Importers need to confirm the Pharmaceuticals and Medical Devices Act classification for each item—even when handling the device, reagents, consumables, software, apps, and judgment algorithms as a single product.
Differences from Research Reagents
A frequent source of confusion in import practices is the difference between research reagents and in vitro diagnostic drugs.
Research reagents are used for research, experiments, and analyses.
In contrast, in vitro diagnostic drugs are used for tests and judgments regarding disease or health status using human-derived specimens.
Even if labeled overseas as "Research Use Only," "RUO," or "laboratory reagent," usage or advertising in Japan for diagnostic, testing, or health judgment purposes does not necessarily qualify as research use.
Especially when using expressions such as "easy to test at home," "can determine infection status," "can check health condition," or "can assess disease risk" on e-commerce sites or brochures, confirmation under the Pharmaceutical and Medical Device Act is required.
Difference Between General Use Test Kits and Test Kits for Medical Institutions
In vitro diagnostic medical devices include test kits for general consumers and those used in medical institutions or testing laboratories.
For products intended for general consumers, since the users are not medical professionals, usage instructions, interpretation methods, labeling, manuals, advertising expressions, safety, and caution notes on false results become important.
For products intended for medical institutions or testing laboratories, specialized testing environments, measurement devices, testing procedures, quality control, test items, and intended use are checked.
Importers need to clearly identify whether the sales destination is for medical institutions, testing laboratories, pharmacies, or general consumers.
If import arrangements proceed without clarifying the sales destination or users, necessary procedures and labeling verification may be delayed.
Comparison with Other Systems and Similar Products
| Category | Main Meaning | Difference From In Vitro Diagnostic Medical Devices | Documents to Confirm | Practical Notes |
|---|---|---|---|---|
| In Vitro Diagnostic Medical Devices | Test kits and diagnostic reagents used with human-derived specimens for disease diagnosis or health status assessment. | Not used directly on the human body but treated as medicines for diagnostic purposes. | Intended use, target specimens, test items, approval/certification/notification documents | Verify intended use and sales method within Japan rather than product name. |
| Medical Devices | Instruments and apparatus intended for diagnosis, treatment, prevention of disease, etc. | Main measuring devices, apparatus, or software may be classified as medical devices. | Device specifications, software documentation, intended use, medical device classification | When importing device and reagent sets, confirm both. |
| Research Use Only Reagents | Reagents intended for research, experiments, and analysis. | Products marketed for diagnosis, judgment, or health assessment may not be classified as research use only. | RUO markings, sales destinations, advertisements, user manuals, domestic uses | Do not rely solely on overseas Research Use Only labels for classification. |
| General Use Test Kits | Test kits for use by general consumers. | Used for self-testing, making labeling, instructions, and false result risks important factors. | Package inserts, user manuals, advertisements, sales destination information | Verify whether sales to the general public are allowed and that advertising expressions are appropriate. |
| Test Kits for Medical Institutions | Test kits used in medical institutions or testing laboratories. | Assumed use in professional testing environments and as diagnostic support. | Sales destination, usage environment, package inserts, approval documentation | Take care not to repurpose for general consumer sales. |
| Miscellaneous Goods / General Reagents | General reagents and supplies not intended for diagnosis or disease judgment. | If human-derived specimens are not used and diagnosis/judgment is not claimed, may be classified separately. | Purpose explanations, sales documents, advertisements, target users | Using disease names or diagnostic expressions in advertising may trigger regulatory oversight. |
| Health Foods / Healthcare Products | Products intended for health maintenance or nutritional supplementation. | Have objectives different from test kits that perform testing and diagnosis. | Product descriptions, advertisements, efficacy claims, sales methods | Additional confirmation is required if disease risk assessment based on test results is claimed. |
Relation to Companion Diagnostic Drugs
Companion diagnostic drugs are in vitro diagnostic medical devices used in tests related to appropriateness decisions, administration eligibility, effect predictions, or side effect risk assessment of specific pharmaceuticals.
Compared to regular test reagents, target diseases, target drugs, test purposes, and how the test results are used become more important.
In import practice, it is necessary to confirm whether the test is linked with drug usage decisions rather than treating it simply as a test reagent.
Products of this kind often involve issues related to approval content, intended use, target patients, package inserts, and conditions of use in medical institutions, requiring specialist pharmaceutical regulatory confirmation on the importer side.
Applicable Requirements and Exclusions
| Category | Concept of Applicability or Exclusion | Documents to Verify | Points of Caution |
|---|---|---|---|
| Items likely classified as In Vitro Diagnostic Medical Devices | Products using human-derived specimens intended for diagnosing, testing, determining, or evaluating health conditions. | Intended use, target specimen, test items, labeling, advertising | Check based on intended use within Japan, not by product name. |
| Items that may be classified as for Research Use Only | Products used only for research, experiments, or analysis, without claims of diagnosis, determination, or health evaluation. | RUO labeling, sales destinations, research plans, sales materials | Claiming diagnostic use on domestic sales pages can cause issues. |
| Items requiring confirmation as Medical Devices | Includes measuring instruments, testing devices, diagnostic equipment, software, etc. | Device specifications, software functions, intended use, diagnostic capabilities | Classify reagents and devices separately for confirmation. |
| Sales to General Consumers | Check whether products can be sold as general-use and whether labeling, explanations, and advertising are appropriate. | Instructions for use, advertisements, package inserts, sales destination information | General sales overseas do not guarantee permission to sell in Japan. |
| Sales to Medical Institutions and Testing Facilities | Verify that use is intended for specialized testing environments and medical settings. | Sales destination, user facilities, testing procedures, quality control documentation | Confirm these are not diverted for general consumer use. |
| Items difficult to categorize as excluded | Products like self-check kits, rapid tests, wellness tests that claim health status evaluation. | Advertising, e-commerce pages, product packaging, sales destinations | Even without naming diseases, expressions close to diagnosis or determination require verification. |
| Items undergoing domestic processing after import | Cases where labeling, repacking, packaging, package insert inclusion, storage, etc., are conducted domestically. | Details of operations, storage location, labeling content, permits and registration documents | Even if it looks like logistics work, it may involve manufacturing activities under the Pharmaceutical and Medical Device Act. |
Main Procedures for Import and Sales
When importing and selling in vitro diagnostic medical devices for commercial purposes, manufacturing and sales permits, manufacturing registrations, foreign manufacturer registrations, and product-specific approvals, certifications, or notifications may be required.
The necessary procedures vary depending on the test items, intended use, risk classification, generic name, sales destinations, and whether storage, labeling, and packaging operations are conducted domestically.
Importers cannot simply purchase products from overseas manufacturers and sell them. They must confirm who will be the manufacturer and sales business operator in Japan, where storage, labeling, and packaging will take place, whether registration of the foreign manufacturer is required, and if product-specific procedures have been completed.
| Verification Item | Main Content | Common Causes of Delays |
|---|---|---|
| Classification under the Pharmaceutical and Medical Device Act | Whether the product falls under in vitro diagnostic medical devices, medical devices, research reagents, or miscellaneous goods | Judging only by the overseas product name without confirming intended use domestically |
| Sales Purpose | Whether for research, medical institutions, testing facilities, or general consumers | Importing as research use but advertising diagnostic or determination purposes on sales pages |
| Permits and Registrations | Need for manufacturing and sales permits, manufacturing registrations, or foreign manufacturer registrations | Importer acts only as seller without a proper manufacturing and sales business setup |
| Product-specific Procedures | Requirement for approvals, certifications, or notifications per product | Mistakenly assuming Japanese procedures can be skipped because the product is already sold overseas |
| Labeling and Package Inserts | Displays of intended use, test items, usage instructions, determination methods, precautions | Japanese labeling or consistency with the scope of approvals, certifications, and notifications not confirmed |
| Advertising and Sales Pages | Expressions regarding diagnosis, determination, disease names, health status evaluation | Use of efficacy or effect expressions subject to review under the Pharmaceutical and Medical Device Act on e-commerce sites or social media |
Application Workflow
- Do not judge solely by the product name; verify intended use, target specimen, test items, and sales destinations.
- Confirm whether the product uses human-derived specimens.
- Check whether the product is intended for diagnosis, testing, determination, or health status evaluation.
- Categorize whether it is for research use, medical institutions, testing facilities, or general consumers.
- Verify its classification under the Pharmaceutical and Medical Device Act as in vitro diagnostic medical device, medical device, research reagent, or miscellaneous good.
- If it possibly qualifies as an in vitro diagnostic medical device, confirm the structure of the manufacturer and sales business operator, manufacturers, and foreign manufacturers.
- Confirm whether product-specific approvals, certifications, or notifications are necessary.
- Verify Japanese labeling, package inserts, usage instructions, determination methods, and precautions.
- Check advertising expressions on e-commerce sites, pamphlets, social media, video advertisements, etc.
- Before customs clearance, confirm with the importer, customs broker, pharmaceutical affairs personnel, and specialists as necessary.
- Confirm post-import storage, labeling, repacking, packaging, and operations until sales commencement.
Import Logistics Workflow
| Stage | Main Points to Check | Common Causes of Hold-ups |
|---|---|---|
| Before Purchasing | Confirm intended use, inspection items, specimen types, customers, and labeling details | Judging simply from overseas manufacturer’s product description that it is for research or miscellaneous use |
| Before Import Arrangement | Check classification under the Pharmaceutical and Medical Device Act, approvals/certifications/notifications, business permits, and manufacturer information | Exporter ships cargo before importer completes pharmaceutical regulatory checks |
| At Customs Declaration | Organize product name, purpose, sales objective, applicable regulations, and required documents | Invoice states only "test kit" or "diagnostic reagent," leaving purpose unclear |
| Customs and Customs Broker Confirmation | Verify whether human-derived specimens are used, whether the purpose is diagnosis/judgment, and whether procedures under the Pharmaceutical and Medical Device Act are completed | Declared as for research but sales materials suggest diagnostic use |
| Domestic Storage and Labeling | Confirm storage conditions, Japanese labeling, package inserts, repackaging operations, and necessity of manufacturer registration | Labeling or repackaging conducted domestically without confirming registration or management systems |
| Before Sales Start | Check that advertising expressions, e-commerce sites, brochures, and SNS posts fall within approval and certification scope | Excessive diagnostic, disease name, or judgment effect claims displayed on sales pages after import |
Common Problematic Situations in Import Operations
For in vitro diagnostic drugs, it is sometimes difficult to judge from the cargo name alone.
Especially for research reagents, testing kits, self-check products, simple judgment kits, and analytical reagents, the handling under the Pharmaceutical and Medical Device Act may differ depending on use and labeling.
| Case | What Could Be Problematic | Documents to Verify | Practical Measures |
|---|---|---|---|
| Importing as research reagent but actually selling for diagnostic purposes | Distinguishing borderline between research use and diagnostic use can be an issue. | RUO labeling, sales pages, advertising copy, customer materials | Confirm actual domestic use purposes and advertising expressions. |
| Importing consumer test kits sold overseas | Just because sold commercially overseas does not guarantee general sales in Japan. | Product descriptions, package inserts, customers, approval-related documents | Check eligibility for general consumer use and required procedures. |
| Claims related to infection, pregnancy, ovulation, blood sugar, etc. | Because it relates to diagnosing disease or physical conditions, Pharmaceutical Act confirmation is necessary. | Advertising text, packaging, instructions, inspection item data | Verify consistency between approval/notification scope and labeling content. |
| Sales toward medical institutions, testing labs, or pharmacies | Required labeling and procedures vary depending on customers and users. | Customer data, usage environment, package inserts, instructions | Keep general consumer and medical institution use separate. |
| Using test results for disease diagnosis or health assessment | May be regarded as diagnostic/judgment use rather than simple analytical products. | Explanation materials on test results, advertisements, sales pages | Confirm expressions of use with the regulatory affairs person. |
| Importing test devices and dedicated reagents as a set | May involve both medical devices and in vitro diagnostic drugs. | Equipment specs, reagent documents, software materials | Confirm classification and procedures for each component. |
| Advertising diagnosis or judgment on e-commerce sites or SNS | Expressing efficacy beyond approval or notification scope could cause problems. | Landing pages, ads, SNS posts, videos, brochures | Check advertising expressions before sales start. |
| Labeling or repackaging carried out domestically | Manufacturer registration and quality control systems may become issues. | Work contents, storage location, labels, packaging specifications | Differ between logistics operations and manufacturing acts under the Pharmaceutical Act. |
Points to Consider on Labeling and Advertising
For in vitro diagnostic drugs, it is important to label readable inspection items, intended use, target persons, judgment method, usage precautions, and result interpretation.
Displaying effects, efficacy, or uses beyond approved, certified, or notified scope may cause problems under the Pharmaceutical and Medical Device Act.
Product labels, package inserts, e-commerce sites, brochures, advertising copy, SNS posts, video advertisements, etc., should be reviewed to ensure expressions about diagnosis, judgment, disease names, and health status assessments are appropriate.
Particularly expressions such as "detects illness," "determines infection," "diagnoses at home," or "decides before seeing a doctor" require careful checking of pharmaceutical regulatory applicability and approval scope.
Forwarder and Customs Practical Checks
When cargo names include terms like "test kit," "diagnostic reagent," "laboratory reagent," "rapid test," or "self check kit," freight forwarders and customs personnel should confirm the possibility of classification as in vitro diagnostic drugs.
Freight forwarders are not in a position to make a final determination on applicability under the Pharmaceutical and Medical Device Act.
However, if cargo names, product descriptions, sales materials, or use explanations suggest the need for regulatory confirmation, forwarders should prompt importers to verify and share information early with customs brokers.
If customs inquiries occur, forwarders should collect from importers the use explanations, product documents, sales materials, pharmaceutical confirmation results, and related approval, certification, or notification documents, then relay them to customs brokers.
Forwarders should avoid definitively stating "it's for research use, so there’s no problem" or "this is not a pharmaceutical product."
Four-column Decision Checklist
| Checkpoint | Party to Confirm With | Items to Confirm | Actions if Issues Are Found |
|---|---|---|---|
| During Purchase Consideration | Importer, Overseas Manufacturer | Intended use, target specimen, test items, presence/absence of diagnostic/judgment purpose | Do not ship before pharmaceutical affairs confirmation if the purpose is unclear. |
| When Checking Product Materials | Importer, Regulatory Affairs Personnel | Catalog, package inserts, instructions, RUO labeling, advertising expressions | Conduct pharmaceutical affairs law confirmation if there are any diagnostic, disease name, or health evaluation expressions. |
| Before Import Arrangement | Importer, Customs Broker, Regulatory Affairs Personnel | Pharmaceutical affairs classification, approvals/certifications/notifications, business permits, registrations | Confirm necessary procedures before proceeding with import if requirements are unclear. |
| During Customs Clearance Confirmation | Customs Broker, Importer | Product name, use, sales purpose, target specimen, sales destination | Prepare to submit usage explanations, product materials, and pharmaceutical affairs confirmation documents. |
| When Describing as Research Use | Importer, Customs Broker | Research purpose, sales destination, no diagnostic use, consistency with advertising content | Check that diagnostic purposes are not stated on sales pages. |
| When Importing Device and Reagents Together | Importer, Overseas Manufacturer, Regulatory Affairs Personnel | Classification of main measuring device, reagents, cartridges, software | Do not classify as a single set; confirm classification for each component. |
| Before Domestic Sales Launch | Importer, Advertising Staff, Regulatory Affairs Personnel | EC site, landing pages, SNS, brochures, package inserts, labeling | Revise any advertising expressions that exceed the scope of approval or certification. |
| If Customs Clearance or Sales Are Stopped | Importer, Customs Broker, Regulatory Affairs Personnel | Missing documents, regulatory applicability, required procedures, storage fees, delivery schedule impact | Analyze causes, provide additional documents, or revise sales plans as needed. |
Required Documents
| Document | Content to Confirm | Purpose in Actual Logistics Practice |
|---|---|---|
| Product Catalog | Product overview, intended use, target users, sales destination | Used to confirm classification under pharmaceutical affairs law. |
| Instruction Manual / Package Insert | Usage instructions, judgment method, precautions, test items | Check scope of approval and labeling content. |
| Test Item Explanation Materials | What the product measures and what it judges | Verify relation to diagnosis and health status evaluation. |
| Target Specimen Explanation Materials | Presence or absence of use of blood, urine, saliva, tissues, secretions, etc. | Reference for deciding if it qualifies as an in vitro diagnostic medical product. |
| Sales Destination / User Explanation Materials | Classification of medical institutions, testing institutions, pharmacies, general consumers, research institutions | Confirm required procedures and labeling content. |
| Documents Regarding Approvals, Certifications, Notifications | Whether pharmaceutical affairs procedures are required for each item | Confirm whether import and sales are allowed. |
| Marketing Authorization Holder / Manufacturer Registration Documents | Who is the domestic marketing authorization holder or manufacturer | Confirm import and sales system organization. |
| Foreign Manufacturer Registration Documents | Registration and information of overseas manufacturers | Used to confirm import procedures from overseas manufacturers. |
| Sales Pages / Advertising Materials | Expressions related to diagnosis, disease names, judgment, health state evaluation | Check the appropriateness of advertising expressions. |
| Invoice / Packing List | Product names, quantities, stated uses, importer information | Ensure consistency with explanations given at customs clearance. |
Practical Scenario 1: Importing as Research Use Reagents but Advertising Diagnostic Use on Sales Page
There are cases where importers bring in test reagents labeled "Research Use Only" from overseas manufacturers.
Although these were explained as research-use reagents at import time, the domestic sales page promotes them with claims like "Easy health check at home" or "Check your risk of disease."
In this case, product explanations at import and domestic sales labeling do not match, which might cause issues with classification as in vitro diagnostic medical products under pharmaceutical affairs law and with advertising expressions.
Importers need to organize the scope of use as research-only, sales destinations, labeling content, and presence or absence of diagnostic purposes, and conduct pharmaceutical affairs confirmation as needed.
Practical Scenario 2: Directly Importing and Selling Overseas Consumer-Targeted Test Kits
Some cases involve directly importing test kits intended for overseas general consumers and attempting to sell them similarly in Japan.
However, being generally available overseas does not automatically mean it can be sold to general consumers in Japan.
Before selling in Japan, it is necessary to confirm test items, intended use, target user, judgment methods, approval for general consumer use, approvals/certifications/notifications, and labeling/advertising content.
Failing to confirm these may cause problems at customs clearance, domestic sales launch, advertising screening, or pharmaceutical affairs monitoring stages.
Practical Scenario 3: Importing Test Equipment and Dedicated Reagents as a Set
There are cases where importers bring in small test devices along with dedicated cartridges and measurement reagents as a single set from overseas manufacturers.
In such cases, the device itself may qualify as a medical device, while the dedicated reagents and cartridges may be classified as in vitro diagnostic medical products.
Additionally, if decision software or an app is included, confirmation regarding whether it is a programmed medical device or medical device software may be required.
Importers need to verify the pharmaceutical affairs classification and required procedures for the device, reagents, and software separately, rather than viewing them as a single product.
Practical Scenario 4: When a Freight Forwarder Is Asked to Explain That It’s for Research Use and Therefore Not a Problem
At customs clearance, cargo described as "diagnostic reagent" or "test kit" may be subject to verification, and the shipper may request the freight forwarder to explain that "it’s for research use, so there is no problem."
However, freight forwarders are not in a position to judge whether the product falls under the Pharmaceutical and Medical Device Act (PMD Act).
In this case, the freight forwarder should collect usage explanations, product catalogs, sales destinations, sales webpages, pharmaceutical compliance confirmation results, and documents related to approvals, certifications, or notifications from the importer, and coordinate these with the customs brokerage firm.
Freight forwarders should avoid independently concluding statements such as "This is not an in vitro diagnostic medical device" or "It’s for research use and thus not subject to regulation."
Impact When Customs Clearance or Sales Are Halted
If cargo potentially subject to classification as in vitro diagnostic medical devices is flagged for verification, it can result in customs delays, storage fees, delivery delays, postponement of sales launch dates, and delayed deliveries to medical or testing institutions.
Without confirmation of the required approvals, certifications, notifications, business permits, or registrations, post-import sales may not be possible.
Additionally, even if customs clearance is completed, product sales or advertising within Japan may be challenged if the sales webpages or advertisements violate PMD Act regulations.
Importers need to confirm not only customs clearance but also post-import storage, labeling, advertising, sales destinations, and intended use in advance.
Common Misunderstandings
| Misunderstanding | Correct Understanding | Practical Notes |
|---|---|---|
| If it is Research Use Only overseas, it can also be freely sold in Japan as a research use product. | In Japan, if diagnosis, judgment, or health status evaluation is claimed, it may not be treated as research use. | Check domestic sales webpages and advertising expressions. |
| Because it is not used directly on human bodies, the PMD Act does not apply. | Reagents used outside the body may still be considered in vitro diagnostic medical devices if their purpose is disease diagnosis. | Confirm the specimen type and intended purpose. |
| If it is sold to general consumers overseas, it can be sold in Japan as well. | Whether it can be sold overseas and whether it can be sold under Japan's PMD Act are separate matters. | Check approvals, certifications, notifications, and labeling requirements applicable in Japan. |
| If it just says "test kit," it is a miscellaneous good. | Product names like test kit or diagnostic reagent are triggers to suspect it may qualify as an in vitro diagnostic medical device. | Verify usage, specimen, test items, and sales destinations. |
| A freight forwarder explaining that it is for research means clearance can proceed. | Freight forwarders are not decision-makers under the PMD Act; explanation materials from the importer are required. | Collect usage explanations, product information, and pharmaceutical compliance documents from the importer. |
| Equipments and reagents are a single bundled product, so they can be judged together. | The measuring instrument itself, dedicated reagents, cartridges, and software may need separate classification checks. | Conduct medical device and in vitro diagnostic medical device confirmation for each component. |
| If it can be imported, domestic sales are also not a problem. | Customs clearance and domestic sales are different matters; labeling, advertising, sales outlet, storage, and business permits may also cause issues. | Confirm advertising and labeling before sales launch. |
| Not naming a disease means it is not an issue under the PMD Act. | Even without disease names, expressions claiming health status assessments or visit-to-doctor judgments require verification. | Also check expressions like "risk assessment" and "self-check." |
Practical Points to Note
In vitro diagnostic medical devices, often imported as reagents or test kits, can easily become problematic in customs clearance and domestic sales if the distinction between research, general, and medical use is mistaken.
Importers need to confirm usage, labeling, sales destinations, test items, specimen types, approvals, certifications, notifications, business permits, and registrations in advance.
Freight forwarders are not decision-makers under the PMD Act, but when cargo names or product descriptions suggest they may fall under in vitro diagnostic medical devices, it is important to encourage confirmation with the importer and share information promptly with the customs clearance agent.
Pharmaceutical compliance verification prior to import is especially important for research reagents, simple test kits, infectious disease tests, pregnancy/ovulation tests, blood sugar/urine tests, and diagnostic reagents intended for medical institutions.
Summary
In vitro diagnostic medical devices are regulated products under the PMD Act designed for testing, measuring, and assessing diseases or health status using human-derived specimens.
Even if products are sold overseas as research use, test use, or simple kits, they may be classified as in vitro diagnostic medical devices in Japan if used or sold for diagnosis, testing, or judgment purposes.
Import and sales activities require confirmation of classification under the PMD Act; manufacturing and marketing approval, manufacturing registration, foreign manufacturer registration; approvals, certifications, notifications by item; and labeling and advertising content.
Freight forwarders are not authorized to make judgments under the PMD Act but, upon seeing cargo names like test kit, diagnostic reagent, or laboratory reagent, have a role to confirm with the importer and share information with customs brokers.
The distinction among research use, general use, and medical use, test purposes, labeling, advertising, sales destination, and required procedures are fields that directly impact customs clearance and domestic sales. Pharmaceutical compliance confirmation prior to import is the most critical preventive measure.
