DMAH page preview

DMAH: Designated Marketing Authorization Holder-Summary Ver.

A DMAH lets a foreign medical device or IVD manufacturer sell products in Japan and hold the marketing approval in its own name — without setting up a Japanese entity.

1. Three Regulatory Pathways — Determined by Your Product

Which regulatory pathway your product takes is not a choice. It follows from the JMDN (Japanese Medical Device Nomenclature) code assigned to your device, the class that code carries, and whether a certification standard exists for it. PMDA publishes the JMDN list and the certification and approval standards in English, so you can check all three yourself.

  Class I Class II Class III Class IV
Statutory category General medical device Controlled medical device Specially-controlled Specially-controlled
Pathway Notification (todokede) Certification if a standard exists; otherwise Approval Certification if a standard exists; otherwise Approval Approval (shonin)
Marketing licence needed Type 3 Type 2 Type 1 Type 1
Foreign Special scheme None Available Available Available
DMAH Cannot be appointed Required Required Required

Marketing licences are cumulative: a company holding a higher type is deemed to hold the lower ones. A DMAH with a Type 1 licence can therefore handle products in any class.

Sources:

2. The Foreign Special Approval / Certification Scheme

Normally a Japanese approval or certification is held by a Japan-based marketing authorization holder in its own name, but the foreign special approval and certification scheme is the exception: it lets a foreign party hold it in its own name (PMD Act Art. 23-2-17; Arts. 23-2-23 and 23-3). The scheme also provides for appointing a Japan-based marketing authorization holder, at the time of application, to carry the responsibilities inside Japan. That appointed company is the DMAH.

「外国特例承認（認証）を受けた(受ける)者は、本邦内の必要な措置を採らせるために製造販売業者を選任する必要があります。」

"A party that has obtained, or is obtaining, a foreign special approval or certification must appoint a marketing authorization holder so that the necessary measures are taken within Japan."

Source: "製造販売業者に係る法改正の概要" Tokyo Metropolitan Institute of Public Health, section 選任製造販売業者 https://www.tmiph.metro.tokyo.lg.jp/files/k_iryou/k-kanshi/k_seihantop/e37e03551023875a566852e0560b7fbd.pdf

Note: When the Foreign Special Scheme Does Not Apply

  • Class I (general medical devices) — These go through notification, not approval or certification, and the notification route has no foreign-manufacturer counterpart. Here you contract with a conventional MAH, which files the notification in its own name and places the product on the market.
  • Products manufactured in Japan — The scheme is written for devices exported to Japan by a manufacturer located outside Japan, so a product made in Japan falls outside it by definition. Here too, a conventional MAH obtains the approval or certification in its own name and places the product on the market.

In both cases the registration sits with the MAH, not with you. That is the practical difference from using the foreign special scheme. Changing partners means a formal transfer of the approval or certification, or — for a notification — filing a fresh notification and withdrawing the old one. Either way, it depends on your outgoing partner's cooperation.

「一般医療機器に外国製造医療機器製造販売承認と同等の制度はありません。必ず日本国内の製造販売業者が届出者となります。」「承継の制度はありませんので、製造販売を引き継ぐ者が新たな製造販売届書を提出し、以前の届は適宜廃止してください。」

"For general medical devices there is no system equivalent to marketing approval for foreign-manufactured medical devices. The notifier must always be a marketing authorization holder located in Japan." / "There is no succession procedure. The party taking over marketing must file a new marketing notification, and the previous notification should be withdrawn."

Source: "届出に関する手続き" PMDA, section その他の注意, items 4 and 3 https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0016.html

「外国の事業者が、本邦に輸出する医療機器又は体外診断用医薬品の承認（認証）を受けることができる特例があります。」「外国指定高度管理医療機器製造等事業者【医薬品医療機器等法第23条の2の23第1項】外国において本邦に輸出される指定高度管理医療機器等（厚生労働大臣が基準を定めて指定する高度管理医療機器、管理医療機器又は体外診断用医薬品）の製造等をする者」

"The exception lets a foreign business obtain approval (or certification) for a medical device or IVD that it exports to Japan." / The party eligible for foreign special certification is defined as "a person who manufactures, outside Japan, designated controlled medical devices etc. that are exported to Japan — namely the specially-controlled, controlled, or in-vitro diagnostic devices designated by the Minister of Health, Labour and Welfare" (PMD Act Art. 23-2-23, para. 1).

Source: "製造販売業者に係る法改正の概要（QMS省令・体制省令・GVP省令について）" Tokyo Metropolitan Institute of Public Health, slide 外国特例承認（認証） https://www.tmiph.metro.tokyo.lg.jp/files/k_iryou/k-kanshi/k_seihantop/e37e03551023875a566852e0560b7fbd.pdf

3. What Is a DMAH, and What Does It Do for You?

A DMAH (Designated Marketing Authorization Holder / 選任外国製造医療機器等製造販売業者) is a licensed Japanese company that acts as your legal representative in Japan under the foreign special approval and certification scheme. You — the foreign manufacturer — hold the approval yourself. PMDA's English materials call this party the FRAH, the foreign restrictive authorization holder.

"Foreign restrictive authorization holder: FRAH — A foreign manufacturer who obtains the marketing approvals of medical devices in foreign country. FRAH may designate licensed MAH in Japan and have it market the product."

"Designated MAH: DMAH — MAH designated by FRAH to conduct required quality control duties inside Japan."

Source: "QMS regulation in Japan" Pharmaceuticals and Medical Devices Agency (PMDA), Office of Manufacturing/Quality and Compliance, section 1. Definition (issued 1 April 2015) https://www.pmda.go.jp/files/000203966.pdf

A DMAH handles the full regulatory lifecycle in Japan on your behalf:

  • Regulatory filings — Marketing approval and certification applications, STED (Summary Technical Document／技術文書概要) preparation, and QMS (Quality Management System／QMS省令) conformity assessment
  • Foreign Manufacturer Establishment Registration（医療機器等外国製造業者登録, FMER）— filed by the DMAH as your agent. You remain the applicant; a foreign manufacturer cannot file directly.
  • Quality control (QMS／QMS省令) — Incoming inspection, release decision, and domestic quality oversight
  • Post-market safety (GVP (Good Vigilance Practice)／GVP省令) — Adverse event collection and reporting to the PMDA, recall reporting and management, annual periodic reports, and reporting of overseas actions such as recalls or field corrections taken in other markets
  • Labeling, electronic package inserts & promotion — Preparing and updating the electronic package insert (電子添文, published on the PMDA website), statutory Japanese labeling on the device and its packaging, and review of promotional materials
  • Authority liaison — Direct communication with PMDA, MHLW, and certification bodies（登録認証機関）

「外国製造業者の登録の手続については、申請者は外国製造業者になりますが、原則として当該外国製造業者が製造する医療機器等の日本国内における製造販売業者が『代行者』となり申請書を提出することになります。」「外国製造業者が代行者を介さず直接提出することはできません。」

"The applicant is the foreign manufacturer; as a rule, however, the marketing authorization holder in Japan for the devices concerned acts as the agent and submits the application." / "A foreign manufacturer cannot submit the application directly without going through an agent."

Sources:

  • "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" Japanese Law Translation Database System (Ministry of Justice), Article 23-2-17, paragraph (4) — 選任外国製造医療機器等製造販売業者, rendered in the official translation as "designated holder of marketing authorization for foreign-manufactured medical devices" https://www.japaneselawtranslation.go.jp/en/laws/view/3213#je_ch5sc1at17 (translation based on the 2015 version of the Act)
  • "医療機器等外国製造業者の登録申請について（医療機器、体外診断用医薬品）" PMDA, sections 外国製造業者登録とは and （2）登録申請書の提出 https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0008.html

4. DMAH vs. MAH: How the Two Routes Differ

Which route you take depends on whose name the approval is held in: the DMAH route or the MAH route.

The DMAH route

You hold the approval, and the DMAH carries out the regulatory work inside Japan.

Foreign Manufacturer Establishment Registration (FMER) for each overseas site performing design or main assembly; filed by the DMAH as your agent Medical Device Manufacturing Registration held by the site itself; may be a third-party warehouse Selling / Leasing Licence or Notification depends on the statutory category of the device You — Foreign Manufacturer FRAH: foreign restrictive authorization holder Import Registered Mfg. Site stores the finished product at the time of the release decision; may be a logistics warehouse, not a factory Shipment released only on the DMAH's decision Distributor / Wholesaler / Retail Selling / leasing Medical institutions / General consumers depends on the device DMAH Designated Marketing Authorization Holder Marketing Authorization Licence Handles all regulatory work in Japan • applications, authority liaison • QMS & GVP, incl. post-market • release decision for shipments • labelling, electronic package insert You appoint the DMAH appointment / contract QMS agreement Quality reporting Application Approval is granted in YOUR name — not the DMAH's PMDA / Certification Body reviews the application and grants approval product flow regulatory relationship

The MAH route

A Japan-based company holds the approval in its own name. That company may be your distributor, your contract manufacturer, a specialist regulatory service provider, or your own Japanese subsidiary. The same firms that act as DMAHs also act as MAHs.

Foreign Manufacturer Establishment Registration (FMER) required for the design site; filed by the MAH as agent Medical Device Manufacturing Registration covers assembly, sterilisation and storage in Japan Selling / Leasing Licence or Notification depends on the statutory category of the device Foreign Manufacturer designs the device; a separate company from the Japanese MAH Design transfer, parts or sub-assemblies Registered Mfg. Site (Japan) principal assembly and sterilisation take place here, and the finished product is stored at the time of the release decision Shipment released only on the MAH's decision Distributor / Wholesaler / Retail Selling / leasing Medical institutions / General consumers depends on the device MAH Marketing Authorization Holder (Japan) Marketing Authorization Licence Handles all regulatory work in Japan • applications, authority liaison • QMS & GVP, incl. post-market • release decision for shipments • labelling, electronic package insert Licence / supply agreement between two separate companies QMS agreement Quality reporting Application Approval The approval is granted to the Japanese MAH, not to the foreign manufacturer PMDA / Certification Body reviews the application and grants approval product flow regulatory relationship

The DMAH route cannot be used for Class I devices, which go through notification, or for products manufactured in Japan. Beyond that, the players involved and the licences required are the same in both routes, and the difference comes down to a single point: whose name is on the approval. On the DMAH route the approval stays with you and does not move when you change partners. On the MAH route the approval is that company's asset, and moving it takes a formal transfer and their cooperation.

5. Why DMAH is the Best Route for Foreign Manufacturers

The killer advantage of DMAH is a dramatically faster, leaner start. You retain control of your product approval while outsourcing the complex Japanese regulatory work.

  1. No Japanese entity required — Skip the cost and time of establishing a company, securing an office, hiring the three statutory controllers ("San-yaku"／三役) required by the PMD Act, and obtaining a medical device marketing authorization licence.
  2. You keep the approval in your name — The approval never sits with a commercial partner. If your commercial relationships change, your market access stays with you.
  3. Regulatory expertise, bought in — Companies offering DMAH services work with Japanese regulatory requirements day to day: choosing the right application category, assembling the documentation, and handling QMS conformity assessments. You spend no time climbing the learning curve, and your own team stays focused on the product and the business.

6. References

Reference materials in English

Reference materials in Japanese

7. Related JPRO Pages

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