Japan Medical Device Marketing Authorization Holder
Local Regulatory Support for the Japanese Market
For a foreign company entering Japan, the local regulatory role depends on the product. For medicines and medical devices, the relevant term is often Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (D-MAH). Cosmetics and foods follow different rules, so the term “Authorized Representative” should not be treated as one appointment that covers every product category.
PMDA and Japan’s Ministry of Health, Labour and Welfare (MHLW) oversee regulatory procedures under the PMD Act. The local entity may act as an MAH, D-MAH, product applicant, manufacturer or importer, depending on the product and route.
Japan Authorized Representative: Key Information
Requirement | Details |
Relevant authorities | MHLW and the Pharmaceuticals and Medical Devices Agency (PMDA) |
Medicines | A Japanese MAH generally handles the product marketing authorization; specific foreign-manufacturer routes may use a designated MAH |
Medical devices and IVDs | Approval, certification or notification depends on classification and applicable standards; procedures are handled through a Japanese MAH or appointed Japanese manufacturer |
Cosmetics | Generally do not require product marketing approval, but must comply with Japan’s cosmetic standards and applicable licensing and notification rules |
Foods and health supplements | Follow food rules and applicable Consumer Affairs Agency (CAA) or MHLW requirements; they do not use the PMD Act’s MAH pathway simply because they are called supplements |
Foreign manufacturing sites | Foreign manufacturer accreditation or registration may be required, depending on the product and manufacturing activities |
Fees | Government fees depend on the specific procedure. Private MAH, D-MAH or regulatory service fees are separate. |
MAH, D-MAH and Foreign Manufacturer Accreditation
These terms describe different parts of Japan’s regulatory system.
Marketing Authorization Holder (MAH)
An MAH is a Japan-based licensed company responsible for marketing authorization activities and relevant compliance duties for a product. For medical devices, PMDA states that a foreign manufacturer must obtain the applicable approval, certification or notification through a Japanese MAH or a Japanese manufacturer appointed by the foreign manufacturer.
Designated Marketing Authorization Holder (D-MAH)
A D-MAH is appointed in certain foreign-manufacturer approval arrangements. It has a defined role under that route, including applicable local safety-reporting responsibilities. A D-MAH is not simply another name for any consultant or importer.
Foreign manufacturer accreditation or registration
Foreign manufacturers may need their manufacturing sites accredited or registered with PMDA/MHLW, depending on the product category and manufacturing activities. This is a site-related regulatory step; it does not itself approve the product for sale in Japan. PMDA provides separate procedures for foreign manufacturers of drugs and quasi-drugs, medical devices and IVDs, and regenerative medical products.
Local Regulatory Requirements by Product Category
Product category | Japan-specific consideration |
Medicines and quasi-drugs | The product approval route and local MAH arrangement depend on the application. Foreign manufacturing sites may need the applicable PMDA/MHLW accreditation or registration. |
Medical devices and IVDs | The route depends on device classification and whether an applicable certification standard exists. A Japanese MAH or appointed Japanese manufacturer handles the applicable procedure. |
Cosmetics | Cosmetics generally do not require product marketing approval, but they must comply with Japan’s cosmetic standards. A Japan-based licensed business handles applicable product notifications and import-related procedures. |
Regenerative medical products | These have a separate approval and foreign-manufacturer process; the local authorization arrangement should be confirmed for the product. |
Foods and health supplements | Food and health-claim rules apply. Japan’s CAA identifies “nutritional supplement” and “health supplement” products as foods in general unless they fall within a specific regulated food category or are classified as medicines. |
PMDA identifies separate routes for medical-device classes: Class I devices are notified to PMDA; some Class II and III devices may be certified by a registered certification body where standards exist; other devices require MHLW approval. Class IV devices require approval.
PMDA also states that cosmetic marketing approval is generally not required, but products must meet the Standards for Cosmetics. The actual import and marketing process still involves applicable local business licensing and product notifications.
Food supplements should not automatically be treated as medicines or routed through an MAH. Japan’s CAA explains that products described as nutritional or health supplements are generally foods, and that health-function claims fall under specific food-labeling systems.
What Can a Japanese MAH or Local Regulatory Partner Do?
The role must match the product and the authorization route. Depending on the agreement and applicable license, local support may include:
- Coordinating product applications: Manage submissions through the applicable PMDA/MHLW process.
- Acting as MAH or D-MAH: Hold or perform the relevant marketing-authorization duties where the entity is licensed and appointed for that role.
- Coordinating foreign manufacturer accreditation or registration: Support site-related submissions when required.
- Managing authority communications: Coordinate responses to questions and requests from PMDA or MHLW.
- Supporting product lifecycle actions: Coordinate applicable changes, renewals or other maintenance activities.
- Coordinating local safety reporting: Support required post-market reporting through the responsible Japanese authorization holder.
- Clarifying roles across the supply chain: Document which party is the manufacturer, MAH/D-MAH, importer and distributor.
The foreign manufacturer, local authorization holder and importer should define their responsibilities in writing. A commercial “representative” agreement by itself does not grant an entity the Japanese licenses or authorization-holder status required for a regulated activity.
Japan Market-Entry Process
1. Confirm how the product is regulated
Determine whether the product is a medicine, quasi-drug, medical device, IVD, cosmetic, regenerative medical product or food. Product classification determines which authority and pathway apply.
2. Select the local regulatory route
Identify whether the product requires an MAH, D-MAH, Japanese manufacturer, importer or another locally licensed entity. Do not assume the same arrangement applies to a cosmetic and a medicine, or to every type of device.
3. Confirm foreign manufacturing-site requirements
Check whether the overseas manufacturing site needs PMDA/MHLW accreditation or registration for the product and activities involved. PMDA maintains separate procedures for different product categories
4. Prepare product documents and the local appointment
Prepare the application-specific dossier, manufacturer information and appointment documents. The documents and responsible parties vary by product and route.
5. Submit the applicable product application, certification or notification
For devices, the submission route depends on classification and standards. For cosmetics, product approval is generally not required, but local licensing, product notification and compliance with cosmetic standards still apply.
6. Maintain compliance after market entry
Maintain current product and manufacturing information, manage applicable post-market safety reporting, and assess changes before implementation. PMDA notes that post-marketing safety reports are submitted by the Japanese MAH; foreign-manufacturer approval routes may require the D-MAH to submit them.
How OMC Medical Can Support Japan Market Entry
OMC Medical can help your team assess the appropriate local arrangement and coordinate regulatory support for the product category, including:
- Product classification and pathway assessment
- MAH or D-MAH role assessment
- Foreign manufacturing-site requirement review
- Local appointment and document coordination
- Application, certification or notification support
- Regulatory correspondence and lifecycle planning
Planning to Enter the Japanese Market?
Start by confirming how your product is regulated and which local entity needs to hold or perform each role. OMC Medical can help you map the regulatory steps before you begin a Japan submission.
Frequently Asked Questions
A Marketing Authorization Holder (MAH) is a licensed company based in Japan that takes responsibility for the applicable marketing authorization and regulatory compliance activities for a product. For foreign medical device manufacturers, an MAH or an appropriately appointed Japanese manufacturer may be needed, depending on the regulatory pathway.
An MAH is responsible for the applicable marketing authorization and compliance activities. A Designated Marketing Authorization Holder (D-MAH) is appointed under certain foreign-manufacturer regulatory arrangements and has specific responsibilities under that route, including applicable safety reporting obligations.
Foreign medical device manufacturers generally need to follow the applicable Japanese regulatory route through a Japanese MAH or an appointed Japanese manufacturer. The exact arrangement depends on the device classification, applicable standards and whether approval, certification or notification is required.
The Pharmaceuticals and Medical Devices Agency (PMDA) supports Japan's regulatory review and safety processes for medical devices and other regulated products. Depending on the device and its classification, the applicable pathway may involve PMDA notification, third-party certification or approval by the Ministry of Health, Labour and Welfare (MHLW).
Foreign manufacturer accreditation or registration is a site-related regulatory requirement that may apply to overseas manufacturing facilities, depending on the product category and manufacturing activities. It is separate from product approval and does not, by itself, authorize a medical device for sale in Japan.
The required documents depend on the product and regulatory pathway. They may include manufacturer information, product technical documentation, application-specific dossiers and appointment documents identifying the local regulatory entity and its responsibilities. The current requirements should be confirmed before submission.
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