Japan DMAH providers: who can hold your device approval in Japan

What is a DMAH in Japan?

A foreign company cannot hold a Japanese marketing authorization licence itself. To sell a medical device or IVD in Japan it needs a company in Japan that holds the right marketing authorization holder (MAH) licence (製造販売業許可). Under Article 23-2 of the PMD Act there are four licence types:

• Class 1 licence (第一種医療機器製造販売業) — highly controlled devices (Class III and IV)
• Class 2 licence (第二種医療機器製造販売業) — controlled devices (Class II)
• Class 3 licence (第三種医療機器製造販売業) — general devices (Class I)
• IVD licence (体外診断用医薬品製造販売業) — in-vitro diagnostics

When the foreign maker keeps the approval or certification in its own name, the Japanese company it appoints is the Designated Marketing Authorization Holder (DMAH). The law calls it 選任外国製造医療機器等製造販売業者 (for foreign special approvals, Art. 23-2-17(3)–(4)) or the 製造販売業者 selected by a foreign designated maker (for third-party certification, Art. 23-2-23 and 23-3). The DMAH must hold a licence that matches the product class, and it carries the in-country duties (quality management, post-market safety, adverse-event reports, recalls, labelling in Japanese). Consultancies sometimes call this service “MAH-for-hire”, “independent MAH” or “In-Country Caretaker (ICC)”.

When does a foreign maker need one?

Every foreign manufacturing site must also be registered (医療機器等外国製造業者登録, Art. 23-2-4; PMDA page). That is a separate step from choosing the DMAH.

Can you switch DMAH later?

This is the main reason many foreign makers choose foreign special approval instead of letting a Japanese partner hold the approval:

• Foreign special approval (外国特例承認): the approval belongs to the foreign maker. Changing the DMAH is a notification within 30 days to MHLW (to PMDA for products PMDA reviews), not a new approval (Art. 23-2-18: 「選任外国製造医療機器等製造販売業者を変更したとき…三十日以内に、厚生労働大臣に届け出なければならない」). PMDA’s e-filing form for this is the “選任外国製造販売業者変更届書” (form F84; PMDA filing manual), whose fields are the old and new DMAH’s name, address, licence type and licence date.
• Foreign designated maker certification (認証): the same idea. The maker notifies the certification body that issued the certificate within 30 days of changing the selected MAH (Art. 23-3(2)).
• Approval held by a Japanese MAH in its own name: the approval is the Japanese company’s. Moving it requires a succession (承継, Art. 23-2-11): the holder must hand over the product’s data and records and a notification is filed before the transfer. In practice this needs the current holder’s cooperation.

The new DMAH still needs the right licence class and must take over quality and safety duties (QMS, GVP, complaint and adverse-event handling), so a switch takes contract and preparation time even though no new approval is needed. This is general information, not regulatory advice; confirm the filing route with PMDA or your consultant.

What does a DMAH cost?

Most providers quote case by case. Figures that providers or reputable sources state publicly:

• Pacific Bridge Medical (article dated 14 Aug 2012, describing independent DMAHs in general): “a flat monthly rate for its services, which is usually around $5,000 to $10,000 per month, depending on the registration of the device. The second is a DMAH that charges a lower monthly rate (about $3,000), plus a percentage of sales in Japan.” (source, checked 2026-09-27)
• Pacific Bridge Medical (cost components): “a registration fee for product approval ... A monthly DMAH fee for holding your license and dealing with the PMDA as needed ... A warehouse fee” (source, checked 2026-09-27)
• ICST (fee structure, no amount published): “申請代行費の他、月額固定で「維持管理費」を頂いております (an application fee plus a fixed monthly maintenance fee)” (source, checked 2026-09-27)
• D-MAH Medical Japan (fee structure, no amount published): “「ライセンス費」を月額固定費として頂いております (a fixed monthly licence fee)” (source, checked 2026-09-27)
• Pure Global (global in-country representation price, not Japan-specific): “Starting at $2,000 USD per year for the first device (excluding government fees).” (source, checked 2026-09-27)
• Asia Actual (Japan registration: government/processing fees and time, not a DMAH fee): “from 6 months and US$20,000 to 36 months and US$120,000 (depending on device classification)” (source, checked 2026-09-27)

Fees vary with device class, number of products, post-market workload (complaints, vigilance, labelling) and whether registration work is included. Government fees for PMDA review and QMS inspection are separate.

Track record: who holds how many foreign special approvals?

Third-party certified products (full count)

PMDA publishes one list of all certified devices and IVDs (認証品目リスト, 令和8年7月認証分まで（令和8年9月7日現在）) with a column for the selected MAH of foreign certificate holders. Of 26,951 certificates, 893 name a selected MAH (foreign designated maker route); 576 are still active, spread over 125 companies. Many are the maker’s own Japanese subsidiary or distributor; independent DMAH services are marked. Top 20 by active certificates:

Source: PMDA 認証品目リスト (https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0026.html), PDL1.0; counted and edited by us. Active = no 認証整理日 and no 認証取消日. Approved (Class III/IV via PMDA review) products are not in this list.

Approved products (foreign special approval)

In PMDA’s lists of approved new and improved medical devices from April 2025 to June 2026, 40 of 434 approvals were issued to a foreign applicant, i.e. under foreign special approval with a DMAH in Japan (our count from PMDA’s lists; approvals whose applicant is a company outside Japan). PMDA’s approval lists do not name the DMAH. Approval numbers of foreign special approvals carry the code BZI (e.g. 30800BZI00017000).

For approved products the DMAH is printed in the electronic package insert (field “選任製造販売業者”) and often in the maker’s press release or the reimbursement notice. We have not counted all approved products per DMAH; below are examples we verified from public sources.