Medical Device Marketing Authorization Holder License — Import Sales Licensing, Registration and Product Procedures
Interlink編集部What is a Medical Device Manufacturing and Marketing License?
A Medical Device Manufacturing and Marketing License is a permit under the Pharmaceutical and Medical Device Act that designates the responsible entity for manufacturing and marketing medical devices within Japan.
Here, manufacturing and marketing does not only mean physically producing the medical devices. It refers to the responsibility for placing medical devices—either manufactured domestically or imported—on the Japanese market.
In import operations, when selling overseas-made medical devices in Japan, it is necessary not only to confirm whether customs clearance is possible but also to verify who will be responsible as the manufacturing and marketing license holder domestically, whether manufacturing registration or foreign manufacturer registration is required, and whether approvals, certifications, or notifications are needed for each product category.
A medical device manufacturing and marketing license holder is not merely an importer or sales agent. They bear responsibility for quality control, safety management, market release decisions, post-market safety measures, complaint handling, and recalls.
Scope Covered in This Article
| Scope | Contents Organized in This Article | Topics to Confirm Separately or in Other Articles |
|---|---|---|
| Basics of the Medical Device Manufacturing and Marketing License | Organized as a license to become the responsible entity placing medical devices on the Japanese market. | The definition and applicability of medical devices themselves are covered in a separate article titled "Medical Device." |
| Role of the Manufacturing and Marketing License Holder | Summarized as the responsible party for quality control, safety management, market release decisions, defective information, complaint handling, and recall management. | Details on organizational structure, responsible person requirements, and procedural manuals should be confirmed with pharmaceutical regulatory experts. |
| Types of Licenses | Explains the differences among Type 1, Type 2, and Type 3 Medical Device Manufacturing and Marketing Licenses. | Class classification, generic names, and product-specific procedures require individual confirmation. |
| Manufacturing Registration | Organizes registration of manufacturing sites in Japan where storage, packaging, labeling, and pre-shipment tasks take place. | It should be individually confirmed whether warehouse operations fall under registration requirements depending on the specific work involved. |
| Foreign Manufacturer Registration | Organizes the registration requirements for overseas manufacturing sites including name, location, and manufacturing scope. | Obtaining information from overseas manufacturers, responding to changes, and renewal management require case-by-case verification. |
| Product-Specific Approval, Certification, Notification | Clarifies that individual product procedures are necessary in addition to the license and registrations. | Details on approval applications, certification, notifications, and QMS conformity investigations require specialist consultation. |
| Freight Forwarder and Customs Operations | Summarizes documents to be checked at import, matters not to be concluded definitively, and handling customs inquiries. | Freight forwarders are not the final decision-makers for Pharmaceutical and Medical Device Act permits, registrations, or product procedures. |
Positioning of This Article
This article organizes the Medical Device Manufacturing and Marketing License, manufacturing registration, foreign manufacturer registration, product-specific approvals, certifications, notifications, responsible entities, domestic storage and labeling operations, and customs confirmation points required when importing and selling overseas medical devices in Japan.
Definitions of medical devices, applicability, class classification, boundaries with household beauty devices, differences from in vitro diagnostic drugs, and program-based medical devices are covered in the separate article "Medical Device."
This article assumes applicability as a medical device and mainly focuses on who should check which permits, registrations, and product procedures and at what stages to actually import and sell medical devices in Japan.
What is a Manufacturing and Marketing License Holder?
A medical device manufacturing and marketing license holder is the responsible party placing medical devices on the Japanese domestic market.
This party is not necessarily the actual manufacturer at the factory. Even when importing medical devices manufactured overseas and selling them in Japan, a manufacturing and marketing license holder is required to take responsibility for placing the product on the market in Japan.
The license holder manages quality control, safety management, market release decisions, collection of defect information, recalls, and management of labeling and attached documents.
Therefore, simply considering "acting as a sales agent for an overseas manufacturer" or "importing and delivering to customers" risks overlooking the responsible entity under the Pharmaceutical and Medical Device Act.
Categories of Medical Device Manufacturing and Marketing Licenses
The Medical Device Manufacturing and Marketing License is divided based on the risk classification of the medical devices handled.
| License Category | Main Target | Practical Significance | Common Causes of Delays |
|---|---|---|---|
| Type 1 Medical Device Manufacturing and Marketing License | Medical devices including highly controlled medical devices | Relevant when handling high-risk medical devices. | Failing to confirm the license category when dealing with highly controlled medical devices. |
| Type 2 Medical Device Manufacturing and Marketing License | Medical devices mainly managed medical devices | Relevant when placing managed medical devices on the market. | Confusing Class II device certification/approval with license category. |
| Type 3 Medical Device Manufacturing and Marketing License | General medical devices | Relevant when placing general medical devices on the market. | Misunderstanding that no license is needed for Class I devices. |
Even for Class I general medical devices, confirmation of product-specific notifications, manufacturing and marketing license, and manufacturing registration is not exempted.
Importers should first confirm medical device applicability and class classification, then organize the required manufacturing and marketing license category.
Differences Between Manufacturing and Marketing License, Manufacturing Registration, and Foreign Manufacturer Registration
In importing and selling medical devices, it is necessary to understand separately the manufacturing and marketing license, manufacturing registration, and foreign manufacturer registration.
| Item | Main Content | When Required | Common Causes of Delay | Practical Response |
|---|---|---|---|---|
| Medical Device Manufacturing and Marketing Authorization | This is the license required to be the responsible entity for shipments into the domestic market. | When selling, leasing, or granting overseas-manufactured medical devices within Japan. | When the importer lacks awareness and does not designate the marketing authorization holder properly. | Confirm who will be the marketing authorization holder before ordering. |
| Medical Device Manufacturing Registration | Registration related to manufacturing facilities that carry out domestic storage, packaging, labeling, or affixing of labels. | When final product storage, labeling, packaging, or pre-shipment processing is conducted at a domestic warehouse. | When storage or labeling at logistics warehouses is considered just simple logistics work. | Confirm the work content and whether registration is required. |
| Foreign Manufacturer Registration | Registration concerning foreign manufacturing sites producing medical devices overseas. | When selling medical devices produced at overseas manufacturing sites within Japan. | When manufacturing site information cannot be obtained from the overseas manufacturer. | Obtain manufacturing site name, location, and manufacturing scope as early as possible. |
| Approval, Certification, and Notification by Product | Procedures specific to each individual medical device item. | Required before market shipment depending on class classification and standards. | When assuming that having a business license alone permits selling all individual items. | Verify generic name, class classification, and status of product procedures. |
Business licenses and registrations relate to the business operator and manufacturing sites, whereas approvals, certifications, and notifications relate to individual product items.
Either alone is insufficient. For importing and selling medical devices, it is necessary to verify both the operator's system and the procedures for individual items.
Approval, Certification, and Notification by Product
When importing and selling medical devices, in addition to the manufacturing and marketing authorization and manufacturing registration, approval, certification, or notification by product may also be required.
Which procedure applies depends on factors such as the generic name, class classification, existence of certification standards, intended use, structure, performance, and equivalence with existing products.
| Procedure | Main Target | Main Practical Content | Practical Points to Note |
|---|---|---|---|
| Notification | Mainly general medical devices | Submit sales name, generic name, shape/structure, intended use, marketing authorization holder, etc. | Notification items still require marketing authorization and manufacturing registration. |
| Certification | Controlled medical devices with certification standards | Receive confirmation of conformity to standards by registered certification bodies. | If the certification standards are not met, approval may be required. |
| Approval | Highly controlled medical devices, new medical devices, controlled devices without certification standards | Undergo evaluation for quality, efficacy, safety, performance, and clinical assessment. | Documentation preparation and review periods can significantly impact import and sales planning. |
Even if a medical device is approved, certified, or sold overseas, this does not guarantee it can be sold in the same way in Japan.
Importers should confirm the generic name, class classification, intended use, and necessity of product procedures within Japan.
Applicable Requirements and Exemptions
| Category | Concept | Documents to Check | Practical Points |
|---|---|---|---|
| Import of Medical Devices for Sales Purposes | When the devices are sold, leased, granted, used for business, or delivered to medical institutions within Japan. | Sales plan, buyers, manufacturing and marketing authorization, product procedure documents | Confirm marketing authorization holder, manufacturing registration, foreign manufacturer registration, and product procedures. |
| Import for Personal Use | Import limited to a certain extent for personal use only. | Quantities, usage, order history, sales plans (if any) | Devices cannot be diverted to domestic sales, resale, or leasing. |
| Samples for Research and Evaluation | Import for evaluation, research, or testing prior to sales. | Description of use, quantity, usage location, sales plans (if any) | Ensure clear distinction of use and management to avoid confusion with sales purposes. |
| For Exhibitions and Demonstrations | Import for display, explanation, negotiations, or demonstration purposes. | Exhibition materials, plans for return shipment, sales plans (if any), usage scope | If sold or delivered after an exhibition, re-check as sales-purpose import. |
| Parts and Repair Materials | Import as parts, replacement parts, or repair materials rather than the device main body. | Purpose of parts, target device, sales destination, repair system | Even parts related to the device main body or maintenance require confirmation. |
| Unapproved, Uncertified, or Unnotified Products | Medical devices for which product procedures have not been completed in Japan. | Status of product procedures, use description, sales plans, test plans | May not be marketable for sales purposes. |
| Devices Described as General Goods | Imported as health devices, beauty equipment, measuring instruments, etc. | Advertisements, specifications, intended use, explanation of physical effects | Check for medical device applicability if medical use is claimed. |
Obtaining Marketing Authorization In-house
Importers may obtain the medical device manufacturing and marketing authorization themselves and act as the marketing authorization holder for market shipment.
In this case, the importer is not merely a seller but becomes the responsible entity under the Pharmaceutical and Medical Device Act.
It is necessary to establish quality control, safety management, responsible personnel systems, procedural documents, record management, incident reporting, complaint handling, and recall response processes.
Additionally, it is essential to organize the permit categories corresponding to the class of the medical devices handled, as well as the approval, certification, and notification requirements by product, foreign manufacturer registration, and domestic manufacturer registration.
When Outsourcing to a Licensed Business Operator
If the importer does not hold a medical device manufacturing and marketing business license themselves, there is an option to outsource to a manufacturer and marketer who already holds the necessary license.
In such cases, it is important to clearly define who is displayed as the manufacturing and marketing business operator, who makes the market shipment decisions, and who is responsible for quality and safety management.
If the division of roles between the seller, importer, manufacturer and marketer, domestic storage warehouse, overseas manufacturer, and foreign manufacturer is unclear, issues may arise concerning labeling, notifications, responsibility allocation, and recall handling.
Even when outsourcing, importers cannot freely engage in advertising or sales representations. It is necessary to confirm the scope of approvals, certifications, notifications, attached documents, advertising expressions, and sales destination management.
Comparison Between Obtaining License In-House and Outsourcing to Licensed Operators
| Category | Main Features | Advantages | Potential Issues | Practical Measures |
|---|---|---|---|---|
| Obtaining manufacturing and marketing license in-house | The importer becomes the manufacturer and marketer, bearing responsibility for market shipment. | Enables integrated management of product control, labeling, quality management, and safety management within the company. | Places a heavy burden on responsible personnel systems, quality control, safety management, procedural documentation, revision control, and incident reporting. | Before obtaining the license, establish organizational structure, staffing, procedures, and post-sales management. |
| Outsourcing manufacturing and marketing to a licensed operator | A business operator who already holds a medical device manufacturing and marketing license acts as the manufacturer and marketer. | Even if the importer does not hold a license themselves, they can rely on the licensed operator’s systems. | It can become unclear who is displayed, who makes the market shipment decisions, and who assumes quality responsibility. | Confirm and document the outsourcing contract, display name, responsibility allocation, and product procedure status. |
| Only involved as a seller | The importer or seller remains only the sales interface rather than being the manufacturer and marketer. | Allows concentration on sales activities but requires coordination with the manufacturing and marketing operator. | Risk that the seller may conduct advertising or explanations beyond the approval, certification, or notification scope. | Confirm advertisements, sales pages, and sales materials with the manufacturing and marketing operator. |
| Importing with unclear role divisions | The roles of importer, seller, manufacturer and marketer, warehouse, and overseas manufacturer are not organized. | Might appear to facilitate arrangements in the short term. | Could result in delays or problems with customs clearance, domestic labeling, market shipment, advertising, complaint handling, and recall response. | Before placing orders, finalize responsible parties, domestic processing locations, product procedures, and advertising controls. |
When Storage and Labeling Are Carried Out in Domestic Warehouses
When medical devices imported from overseas are stored, packaged, labeled, or stored prior to shipment at a domestic warehouse, medical device manufacturing business registration may become an issue.
Even if the warehouse is for logistics purposes, operations requiring registration as a manufacturing site under the Pharmaceutical and Medical Device Act could apply.
The necessary checks vary depending on whether goods are simply stored, held as finished products, Japanese labels are applied, package inserts are inserted, or packaging is altered.
Freight forwarders and warehouse operators should be careful not to confuse regular logistics storage with storage and labeling work that requires manufacturing business registration under the Pharmaceutical and Medical Device Act.
Foreign Manufacturer Registration
When marketing overseas-manufactured medical devices in Japan, foreign manufacturer registration may be applicable.
Foreign manufacturer registration involves issues such as the name and location of the overseas manufacturing site, manufacturing processes, manufacturing scope, and manufacturer information.
If the overseas manufacturer is not familiar with Japanese regulatory procedures, it may take considerable time to obtain the required information.
Importers should verify, during price negotiations and ordering stages, whether the overseas manufacturer can cooperate with Japanese registration procedures and provide manufacturing site information.
System Application Flow
- Confirm whether the intended imported product potentially falls under medical devices, in vitro diagnostic drugs, general products, cosmetics, or other categories.
- If it falls under medical devices, check the generic name, classification by class, intended use, and risk classification.
- Confirm which class of manufacturing and marketing business license (Class 1, 2, or 3) is applicable.
- Decide whether to obtain the manufacturing and marketing license in-house or to outsource to an existing licensed operator.
- Confirm whether medical device manufacturing business registration is required at the domestic location where storage, packaging, labeling, or pre-shipment tasks are performed.
- Check whether foreign manufacturer registration is required for the overseas manufacturing sites.
- Verify the necessary approval, certification, or notification requirements for each product.
- Prepare necessary documents such as copies of permits, registration materials, approval/certification/notification documentation, product specifications, and usage explanations for customs clearance.
- Before market shipment, confirm that the manufacturing and marketing operator has verified quality, labeling, package inserts, product procedures, and shipment decisions.
- Before sales start, ensure that advertisements, e-commerce sites, social media, and sales materials correspond with the scope of product procedures.
- After sales begin, continue management of defect information, complaint responses, recall actions, and safety management.
Practical Workflow Until Import and Sales
| Stage | Main Points to Confirm | Common Causes of Hold-ups |
|---|---|---|
| Procurement Review | Confirm whether the product falls under medical devices, in vitro diagnostic drugs, general goods, cosmetics, etc. | Deciding based solely on overseas labeling as "medical device" or "health device". |
| Classification Confirmation | Verify general name, class classification, and whether approval, certification, or notification is required. | Classifying products based only on product name without checking intended use or performance. |
| Determining Responsible Party | Decide whether your company will be the marketing authorization holder or outsource to a licensed entity. | Ambiguity in roles between seller, importer, and marketing authorization holder. |
| Permit & Registration Confirmation | Check marketing authorization approval, manufacturing registration, and foreign manufacturer registration. | Only confirming product-related procedures but overlooking permits and registrations of the business entity. |
| Product Procedure | Confirm the status of approval, certification, or notification applications and filings. | Misunderstanding that Japanese procedures can be skipped because the product is already sold overseas. |
| Import Arrangement | Organize necessary permit copies, registration information, and product documentation for customs clearance. | Discovering lack of documentation right before customs clearance. |
| Domestic Storage & Labeling | Verify labels, inserts, instructions, storage locations, and manufacturing registrations. | Performing labeling work at warehouses without confirming registration requirements. |
| Market Shipment Decision | Marketing authorization holder confirms quality, labeling, and product procedures before shipment. | Misconception that clearance automatically allows sales. |
| Post-Sale | Manage defect reports, complaint responses, recalls, and advertising expressions. | Lack of established safety management and recall system after sales. |
Documents Commonly Checked at Customs Clearance
| Document | What Is Confirmed | Purpose in Practice |
|---|---|---|
| Copy of Medical Device Marketing Authorization Permit | Whether there is a responsible party for market shipment within Japan | Confirm involvement of the marketing authorization holder. |
| Documents Related to Medical Device Manufacturing Registration | Registration of locations where domestic storage, packaging, labeling is performed | Verify legality of domestic operation sites. |
| Documents Related to Foreign Manufacturer Registration | Name, location, manufacturing scope, and registration status of overseas manufacturer | Confirm overseas manufacturer information. |
| Documents Related to Approval, Certification, Notification | Status of procedures per product, sales name, generic name | Confirm whether individual medical devices are in a marketable state. |
| Documents Confirming Generic Name & Class Classification | Medical device classification, risk category, and premise for product procedures | Clarify required permit classifications and procedures. |
| Product Catalogs & Specifications | Intended use, structure, performance, sales destination, user | Used to verify medical device applicability and product procedures. |
| Instruction Manuals & Inserts | Usage, efficacy, precautions, contraindications, labeling content | Verify consistency with approval, certification, and notification scope. |
| Use Descriptions & Sales Destination Documents | Sales purpose, targeted to medical institutions or general consumers, business use | Clarify whether it is personal import or commercial import. |
| Overseas Manufacturer Information | Manufacturer name, location, contact person, manufacturing scope | Used for foreign manufacturer registration and inquiry response. |
| Invoice & Packing List | Product name, quantity, price, importer, cargo details | Cross-check customs declaration info with Pharmaceuticals and Medical Devices Act documents. |
Relationship with Labeling & Advertising
Even when medical device marketing authorization permits, manufacturing registrations, and approvals/certifications/notifications are in place, labeling and advertising are not unrestricted.
Displaying or advertising efficacy, effects, or intended uses beyond the approved, certified, or notified scope as a medical device may cause issues.
Expressions on product pages, instruction manuals, inserts, advertisements, social media, sales materials, and medical institution explanations need to be consistent with the scope of product procedures.
Additionally, even general products not classified as medical devices could be problematic if they claim diagnosis, treatment, prevention, or physical function improvement effects akin to medical devices.
Difference Between Personal and Commercial Imports
For medical devices, it is essential to differentiate between imports for personal use and those for commercial import and sales.
There are different confirmation requirements when importing for personal use versus for sale, resale, lease, business use, or delivery to medical institutions within Japan.
Medical devices obtained via personal import cannot be sold, resold, or distributed domestically in Japan.
When importing and selling for commercial purposes, medical device marketing authorization permits, manufacturing registrations, foreign manufacturer registrations, individual product approvals/certifications/notifications, and labeling and advertising compliance become critical considerations.
Key Points for Freight Forwarders and Customs Practice
When cargo names include terms like "medical device," "health equipment," "beauty device," "measurement device," "monitor," "sensor," or "software," forwarders and customs practitioners should confirm whether the importer has checked licensing, registration, and product procedures under the Pharmaceuticals and Medical Devices Act.
Freight forwarders are not in a position to make the final judgment on whether medical device marketing authorization permits or product procedures are required.
However, in cases where the import involves medical devices for sales purposes, it is necessary to confirm whether the import is for sales or personal use, whether it falls under medical devices, in vitro diagnostic drugs, general goods, or cosmetics, and whether a business operator holding a medical device manufacturing and marketing authorization is involved.
Additionally, it is important to check if storage, labeling, packaging, or label affixing is conducted domestically, whether the domestic operation site is registered as a medical device manufacturer, whether the product requires foreign manufacturer registration, and whether approval, certification, or notification for each item has been completed.
When customs clearance requires verification, the freight forwarder collects copies of permits, registration information, approval/certification/notification documents, product materials, usage explanations, and specifications from the importer, and coordinates with the customs broker.
Freight forwarders should avoid definitively stating, "This is not a medical device," "No permits are required," or "Since it is sold overseas, there is no problem."
Scope of Freight Forwarder Involvement
| Category | What the Forwarder Can Support | What Should Not Be Definitively Stated | Practical Response |
|---|---|---|---|
| If it is found to be an import of medical devices for sales purposes | The forwarder can confirm with the importer the status of permits, registrations, and item procedures. | The forwarder should not definitively state that manufacturing and marketing authorization and item procedures are unnecessary. | Share information promptly with the customs broker. |
| If requested to present permits or registration documents | The forwarder can collect copies of permits, registration documents, and item procedure documents from the importer. | The forwarder should not respond that there are no problems without documentation. | List any missing documents and request them from the importer. |
| If labeling or label affixing is done at a domestic warehouse | The forwarder can encourage confirmation of medical device manufacturing registration for the domestic operation site. | Do not definitively state that label affixing is merely a logistics operation and registration is unnecessary. | Confirm work contents, registration status, and the outsourcing relationship. |
| If information on the overseas manufacturer is insufficient | The forwarder can request the importer to obtain the manufacturing site name, location, manufacturing scope, etc. | Do not conclude that the manufacturer’s name alone is sufficient for foreign manufacturer registration. | Encourage obtaining necessary information during purchase negotiations. |
| If consulted about advertising expressions | The forwarder can indicate that advertising confirmation is subject to pharmaceutical affairs, labeling, and legal review. | The forwarder is not in a position to approve efficacy claims on sales pages. | Encourage the importer to verify consistency with item procedure scope. |
| If customs clearance is halted | The forwarder can organize missing documents, inquiry contents, and regulatory confirmation items. | The forwarder should not be the final judge on permit requirements or sale approval. | Connect the importer, customs broker, and pharmaceutical affairs personnel for verification. |
Common Practical Issues
| Case | Likely Problems | Documents to Confirm | Practical Notes |
|---|---|---|---|
| No manufacturing and marketing authorization holder decided despite sales purpose | Responsibility for market shipment is unclear, preventing domestic sales. | Sales plans, outsourcing contracts, manufacturing and marketing authorization certificates | Decide whether to obtain authorization internally or outsource to an authorized party. |
| Manufacturing and marketing authorization acquired, but item procedures unconfirmed | Having authorization does not guarantee market shipment of individual medical devices. | Approval letters, certification documents, notification forms, generic names, class classification materials | Confirm status of procedures for each item. |
| Storing final products and affixing labels at a domestic warehouse | This may fall under work requiring medical device manufacturing registration. | Warehouse information, work content, registration documents, outsourcing contracts | Separate logistics operations from manufacturing acts under the Pharmaceuticals and Medical Devices Act in confirmation. |
| Unable to obtain information necessary for foreign manufacturer registration | Manufacturing and marketing procedures in Japan may not proceed. | Overseas manufacturing site name, location, manufacturing scope, quality-related information | Confirm overseas manufacturer cooperation feasibility before order placement. |
| Skipping Japanese procedures claiming prior overseas sales | Overseas authorization and Japan’s approval, certification, notification are separate. | Overseas authorization documents, Japan generic names, class classifications, item procedure documents | Individually confirm necessity for procedures in Japan. |
| Advertising exceeds the scope of permits or item procedures | Possible claims of efficacy/effects beyond approval, certification, or notification scope. | Advertising text, e-commerce pages, package inserts, approval/certification/notification documents | Check advertising expressions before launch. |
| Reselling items imported as personal use | Confusion between personal use import and commercial import purposes. | Quantity, sales destinations, e-commerce listing information, order history | If there is a sales purpose, confirm it as commercial import. |
| Confusing medical device sales and leasing business | Manufacturing marketing holders have market shipment responsibility, different from sales or leasing permissions/notifications. | Sales forms, offices, handled items, manufacturing marketing holder information | Confirm manufacturing and marketing authorization separately from sales and leasing permissions. |
Four-Column Decision Checklist
| Check Point | Party to Confirm With | Items to Confirm | Actions if Issues Are Found |
|---|---|---|---|
| At Purchase Evaluation | Importer, Overseas Manufacturer | Applicability as medical device, generic name, class classification, intended use, classification in sales countries | If classification is unclear, conduct pharmaceutical regulatory checks before placing orders. |
| When Determining Responsibility | Importer, Marketing Authorization Holder, Pharmaceutical Affairs Staff | Whether your company will act as the Marketing Authorization Holder or outsource to a licensed party | Avoid proceeding with import arrangements while this is undecided. |
| When Confirming Permit Category | Marketing Authorization Holder, Pharmaceutical Affairs Staff | Which permit category is required: Class I, II, or III | Confirm the permit category matches the class of product handled. |
| When Confirming Domestic Operations | Importer, Warehouse, Manufacturer | Storage, packaging, labelling, attachment of Japanese inserts | Verify whether medical device manufacturing registration is required for the operations. |
| When Confirming Foreign Manufacturer | Importer, Overseas Manufacturer, Pharmaceutical Affairs Staff | Overseas manufacturer name, location, manufacturing scope, registration status | If information is insufficient, confirm with the manufacturer before ordering. |
| When Confirming Product Procedures | Marketing Authorization Holder, Pharmaceutical Affairs Staff | Whether approval, certification, or notification is required; whether procedures are completed | If not completed, confirm the procedure status before market release. |
| When Confirming Customs Clearance | Importer, Customs Broker | Copies of permits, registration documents, approval/certification/notification documents, specifications, usage explanations | Collect missing documents from the importer and coordinate with the customs broker. |
| Before Market Release | Marketing Authorization Holder, Manufacturer, Importer | Quality, labelling, attached documents, product procedures, storage conditions, market release approval | Confirm products are not sold before market release approval, even if customs cleared. |
| Before Sales Start | Importer, Seller, Advertising Staff, Pharmaceutical Affairs Staff | Advertising, EC pages, SNS, sales materials, consistency with approval/certification/notification scope | Correct expressions that exceed the approved scope of efficacy and effects. |
Practical Scenario 1: Sales Intent Without Established Marketing Authorization Holder
There are cases where an importer procures overseas-made measuring instruments and intends to sell them domestically in Japan.
However, it is not determined who will act as the medical device Marketing Authorization Holder responsible for market release.
The importer might assume they are merely selling the overseas manufacturer's products "as-is," but in Japan, there must be a responsible entity for market release.
In such cases, it is necessary to decide whether to obtain the Marketing Authorization Holder license in-house or outsource this responsibility to an existing licensed party.
Practical Scenario 2: Marketing Authorization Exists but Product Procedures Are Unconfirmed
Some importers work with businesses that have medical device Marketing Authorization Holder licenses and import overseas medical devices.
However, they have not confirmed whether approval, certification, or notification for each product category is complete.
The fact that the Marketing Authorization Holder license exists does not automatically mean that each specific medical device is approved for market release.
In this case, before proceeding with import and sales, it is necessary to confirm the generic name, class classification, approval/certification/notification status, intended use, and labelling content.
Practical Scenario 3: Final Product Storage and Labelling at Domestic Warehouse
There are cases where medical devices imported from overseas receive Japanese labels and have Japanese inserts packed at a domestic warehouse before shipment.
The importer may consider this merely normal warehouse handling since labelling is done at the logistics warehouse.
However, if activities relate to storage, packaging, labelling, or pre-shipment handling for medical devices, medical device manufacturing registration requirements may come into play.
It is necessary in such cases to confirm the registration status of the operation site, scope of operations, and the division of roles with the Marketing Authorization Holder.
Practical Scenario 4: Inability to Obtain Information Required for Foreign Manufacturer Registration
Importers attempt to procure medical devices from overseas manufacturers.
However, the overseas manufacturer does not provide sufficient information such as manufacturing site name, location, manufacturing processes, manufacturing scope, or quality-related details.
Without the necessary information for foreign manufacturer registration, marketing authorization procedures in Japan may not proceed.
Importers need to confirm with the overseas manufacturer, before price negotiation and ordering, whether they can cooperate with Japanese pharmaceutical regulatory procedures.
Practical Scenario 5: Approval and Product Procedures Are in Place but Advertising Exceeds Scope
Importers have medical device Marketing Authorization Holder licenses and approval for each product, including attached documents, and sell medical devices accordingly.
However, on sales pages, they use expressions exceeding the certified scope, such as "has therapeutic effects," "can be used for all symptoms," or "effects equivalent to medical institutions."
Even if approval and product procedures are in order, if advertising expressions exceed the approved scope, issues under the Pharmaceutical and Medical Device Act could arise.
Importers must not only confirm permits, registrations, and product procedures, but also review advertising expressions before sales start.
Impacts When Customs Clearance or Sales Are Halted
If confirmation of medical device Marketing Authorization Holder permits, manufacturing registration, foreign manufacturer registration, and approval/certification/notification is insufficient, delays in customs clearance, storage fees, delivery delays, delays in delivery to medical institutions, postponement of sales start dates, or re-arranging licensed parties may occur.
Even if customs clearance is obtained, if Marketing Authorization Holder, manufacturer, foreign manufacturer registration, product procedures, labelling, or advertising are incomplete, domestic sales may be prohibited.
Importers need to consider customs clearance and domestic sales together, confirming the overall flow from procurement through to market release.
Role Division with the Medical Device Article
The "Medical Device" article organizes topics such as the definition of medical devices, applicability as medical devices, class classification, boundaries with home-use beauty devices, differences from in vitro diagnostic drugs, and program medical devices.
In contrast, this article "Medical Device Marketing Authorization" focuses specifically on the manufacturing and marketing authorization, manufacturing registration, foreign manufacturer registration, approvals/certifications/notifications, and responsibility arrangements required to import and sell overseas medical devices in Japan.
In actual logistics practice, first check the applicability and classification of medical devices in the "Medical Device" article, and then confirm the specific authorizations, registrations, and item procedures in this article.
Common Misunderstandings
| Common Misunderstanding | Actual Concept | Practical Notes |
|---|---|---|
| The manufacturing and marketing authorization is a permit to actually manufacture in a factory | The marketing authorization holder is the responsible party for market shipment. They may not necessarily be the actual manufacturer. | Avoid confusing manufacturing registration with manufacturing and marketing authorization. |
| If the importer is a sales agent, the marketing authorization holder is unnecessary | When marketing overseas medical devices in Japan, a manufacturing and marketing authorization holder based in Japan is required. | Determine who will be the marketing authorization holder before placing orders. |
| If you have manufacturing and marketing authorization, you can sell any medical device | You need to check authorization categories, item-specific approvals/certifications/notifications, and classification classes. | Confirm authorization and item-specific procedures separately. |
| Class I general medical devices do not require authorization or notification | Even for Class I devices, confirmation of manufacturing and marketing authorization and item notifications may be required. | Do not assume procedures are unnecessary for low-risk devices. |
| Labeling at a domestic warehouse is just logistics work | Storage, packaging, labeling, and marking may require medical device manufacturing registration. | Confirm the nature of the work and registration requirements beforehand. |
| If it is sold overseas, it can be sold in Japan | The permission to sell overseas and the approvals/certifications/notifications under Japan’s Pharmaceutical and Medical Device Act are separate matters. | Check the general product name, classification class, and item procedures in Japan. |
| Advertising is free once permits, registrations, and item procedures are complete | Advertising must be consistent with the approved, certified, or notified scope. | Review sales pages, social media, and promotional materials before sales. |
| Medical device sales authorization and manufacturing and marketing authorization are the same | Medical device sales and leasing authorizations and manufacturing and marketing authorization serve different roles. | Separate responsibility for market shipment and sales/lease management at the sales office. |
Practical Points to Note
Manufacturing and marketing authorization for medical devices is the core permit under the Pharmaceutical and Medical Device Act for importing and selling overseas medical devices in Japan.
However, import and sale do not conclude solely with manufacturing and marketing authorization.
It is necessary to jointly confirm manufacturing registration, foreign manufacturer registration, item-specific approvals/certifications/notifications, labeling and advertising, as well as domestic storage and labeling operations.
Importers must confirm not only product procurement but also the responsible party for market shipment within Japan, domestic storage and labeling locations, item procedures, foreign manufacturer information, and post-sale safety management.
Freight forwarders are not decision-makers under the Pharmaceutical and Medical Device Act; however, for imports of medical devices for sale, they should promptly verify whether the importer has confirmed the necessary permits, registrations, and item procedures and share that information with customs brokers.
Summary
Manufacturing and marketing authorization for medical devices is the Pharmaceutical and Medical Device Act permit designating the responsible party for marketing medical devices within Japan.
When importing and selling overseas medical devices, it is necessary to separately confirm the manufacturing and marketing authorization holder, manufacturers, foreign manufacturers, and item-specific approvals/certifications/notifications.
Possession of manufacturing and marketing authorization does not mean individual items can be marketed.
Importers must confirm who is responsible as the marketing authorization holder, whether the domestic storage and labeling locations are registered, whether foreign manufacturer registration is required, and whether item procedures are completed.
Manufacturing and marketing authorization for medical devices is the practical central issue connecting the responsible party for import and sale, domestic work locations, foreign manufacturer registration, item procedures, labeling and advertising, and safety management.
