Japan MAH / DMAH Services

Compare Japan MAH/DMAH providers. Request quotes, review coverage, and choose a partner for Japan market entry and ongoing support.

23
Providers
3
Pro
🔒 SSL Encrypted
•
✓ Applies GDPR Practices
•
✉ No Spam Guarantee
•
Featured in: MedTech Innovator • DeviceTalks
1,200+
Companies served
24h
Avg. response time
500+
RFQs this month
95%
Satisfaction rate

Compare Japan MAH / DMAH Services Providers

For the most complete service details (including category-specific capabilities and requirements), open any provider profile below. Each profile contains full coverage, service details, and a direct quote request flow.

Sakura RIM Services

Sakura RIM Services offers a diverse range of products, including specialized dental equipment, advanced monitoring cameras, and automotive parts, catering to various professional and personal needs.

Sakura RIM Services is a provider featured in the jp_mah_dmah directory, offering a wide array of specialized products. Their catalog includes items such as Whaledent ParaPost XT Titanium Threaded Posts for dental professionals, the Distancebot Pro 360° Camera Robot for remote monitoring, and Bendix QR-1 Air Brake Quick Release Valves for heavy-duty trucks. Additionally, they offer products like demineralization cartridges for humidifiers, men's velvet blazers, and magnetic letter train sets, demonstrating a broad scope of offerings. The company appears to operate primarily online, with product listings found across various sub-pages of their website. Each product page provides detailed information, customer reviews, and links to essential services like customer support, order tracking, and return policies. The presence of multiple product types suggests a versatile business model, potentially serving both B2B and B2C markets. While specific details about their headquarters or operational history are not provided, the directory listing and product range indicate a focus on specialized goods. The inclusion of multiple product categories, from industrial components to consumer electronics and hobby items, suggests a broad market reach and a commitment to providing diverse solutions to their clientele.
HQ: Nagoya, Japan
Jurisdictions: JP
Countries: JP
Languages: Japanese, English
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Retainer
Starting from: USD 20,000
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Kizuna MedTech Partners

Kizuna MedTech Partners offers AI-powered regulatory submission services for medical devices, streamlining processes from FDA 510(k) to De Novo and PMA.

Kizuna MedTech Partners provides a comprehensive suite of AI-powered regulatory services designed to streamline medical device submissions. Their platform covers a wide range of needs, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions (Pre-Sub), 513(g) Requests, PMA Supplements, Humanitarian Device Exemptions (HDE), and IDE Submissions. Leveraging intelligent automation and expert guidance, Kizuna MedTech Partners aims to simplify complex regulatory pathways. They offer solutions for both FDA and global markets, ensuring compliance and efficiency at every stage of the submission process. Their services are built on an intelligent platform that includes automated compliance checks and expert support. For traditional 510(k) submissions, they manage the complete workflow from device classification to the final submission package, targeting the standard 90-day FDA review. They also support novel, low to moderate-risk devices, with a focus on the upcoming eSTAR mandate. Additionally, they facilitate formal device classification determinations and offer support for 180-day, Real-Time supplements with repeatable templates and checklists.
HQ: Nagoya, Japan
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Chinese, Korean
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Onboarding + annual retainer
Starting from: USD 12,000
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Shinrai RIM Advisors

Cruxi AI offers AI-powered regulatory submission services for medical devices, streamlining processes like FDA 510(k), De Novo, and PMA. They provide an intelligent platform with automated compliance checks and expert guidance.

Cruxi AI specializes in simplifying medical device regulatory submissions through an AI-powered platform. They offer 14 distinct regulatory services covering FDA and global markets, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions (Pre-Sub), 513(g) Requests, PMA Supplements, Humanitarian Device Exemptions (HDE), and IDE Submissions. Their platform utilizes intelligent automation, automated compliance checks, and expert guidance to streamline the entire submission process. This includes traditional 510(k) submissions with a 90-day FDA review, and support for novel, low/moderate risk devices where eSTAR use is mandatory from October 1, 2025. Cruxi AI aims to be a comprehensive solution for all regulatory needs, from device classification to the final submission package.
HQ: Fukuoka, US
Jurisdictions: JP
Countries: JP
Languages: Japanese, English
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Onboarding + annual retainer
Starting from: USD 12,000
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Kintsugi Global Advisors

Kintsugi Global Advisors is a financial advisory firm listed in the jp_mah_dmah directory. They specialize in providing expert guidance for your financial needs.

Kintsugi Global Advisors is a distinguished financial advisory firm featured in the jp_mah_dmah directory. They are dedicated to offering expert insights and strategic guidance to help clients navigate complex financial landscapes. With a commitment to excellence, Kintsugi Global Advisors aims to provide tailored solutions that align with individual and corporate financial objectives. Their presence in the jp_mah_dmah directory signifies their dedication to serving a broader audience seeking reliable financial expertise.
HQ: Yokohama, Japan
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Chinese
Response SLA: 48 hours
Onboarding time: 10–45 days
Pricing model: Per project
Starting from: USD 8,500
Services: MAH, DMAH
View Profile & Get Quote

Hibiki Authorization Partners

Hibiki Path Advisors is an engagement investor focused on Japan's small and mid-cap segment. They integrate with 3D Investment Partners in January 2026.

Hibiki Path Advisors (HPA) has been an engagement investor in Japan's small and mid-cap segment for approximately 10 years, focusing on enhancing corporate value and improving the Japanese capital market. As of January 2026, HPA will integrate its business with 3D Investment Partners Pte. Ltd. (3DIP), a major independent asset manager with a similar investment philosophy. The core members of HPA, including Yuya Shimizu and Victor Foo, will continue their investment activities in the small and mid-cap segment as an independent investment decision-making unit within 3DIP. This strategy will be named the "3D Hibiki Path Aoba Strategy," with Yuya Shimizu serving as CIO. HPA has a history of engaging with investee companies and has published their engagement trends. They have also provided commentary on earnings results for companies like Star Mica Holdings and Tokyo Cosmos Electric, demonstrating their active role in the market. Their investment philosophy emphasizes long-term value creation and contributing to the improvement of the Japanese capital market.
HQ: Kyoto, JP
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Chinese
Response SLA: 48 hours
Onboarding time: 10–45 days
Pricing model: Per project
Starting from: USD 8,500
View Profile & Get Quote

Mirai Authorization Gateway

Mirai Authorization Gateway is a leading provider of hotel distribution and direct channel sales solutions. They offer expertise in booking engines, web projects, metasearch connectivity, and digital marketing.

Mirai Authorization Gateway specializes in empowering hotels to optimize their direct sales channels. Their comprehensive suite of services includes advanced Booking Engines, strategic Web Projects, and efficient Metasearch Connectivity solutions. They also provide expert Digital Marketing, Distribution Consulting, and Omnichannel Management to enhance a hotel's online presence and revenue. With offices across the globe, including Spain, France, Portugal, and the Americas, Mirai ensures close proximity to their clients. Their offerings are designed to help hoteliers gain more control over their distribution, improve direct bookings, and adapt to the evolving digital landscape. Mirai's commitment extends to providing tools like MiraiTwin and MiraiPro, further supporting hotel operations and partnerships.
HQ: Barcelona, Spain
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Korean
Response SLA: 72 hours
Onboarding time: 14–60 days
Pricing model: Custom pricing
Starting from: USD 6,000
Services: MAH, DMAH
View Profile & Get Quote

Asahi Pharma Services

Asahi Kasei Corporation is a global company operating in Materials, Homes, and Healthcare sectors. They focus on innovative chemical technology, sustainable solutions, and improving quality of life through advanced products and services.

Asahi Kasei Corporation is a diversified global company with a strong presence in the Materials, Homes, and Healthcare sectors. Leveraging advanced chemical technology and creativity, they develop environmentally friendly, high-value-added materials and solutions. In the Materials sector, Asahi Kasei offers a wide range of products including electronic devices and materials, automotive interior components, energy and infrastructure solutions like membranes and separators for batteries, and performance chemicals. They are committed to advancing environmental technology and promoting sustainability. The Healthcare sector focuses on contributing to medical therapy progress by addressing unmet medical needs with specialized leading-edge technology, enabling patients to enjoy a better quality of life. Their product offerings span various applications, from pharmaceuticals to life science materials. Asahi Kasei is dedicated to creating a better future through continuous innovation, aiming to contribute to a sustainable society by providing products and services that solve environmental and social challenges.
HQ: Kobe, JP
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Chinese, Korean
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Retainer
Starting from: USD 20,000
Services: DMAH
View Profile & Get Quote

Takumi Regulatory Advisors

Takumi Regulatory Advisors offers AI-powered regulatory submission services for medical devices, including FDA 510(k), De Novo, and PMA. They streamline the process with intelligent automation and expert guidance.

Takumi Regulatory Advisors provides comprehensive regulatory submission services for medical devices, leveraging AI-powered workflows and expert guidance. Their platform covers a range of FDA submissions, including 510(k), De Novo Classification Requests (eSTAR), Q-Submissions, and PMA Supplements. They aim to streamline the entire process from device classification to the final submission package, offering automated compliance checks and intelligent automation. With 14 services covering both FDA and global markets, Takumi Regulatory Advisors positions itself as a single, intelligent platform for all regulatory needs. They offer specialized workflows for traditional 510(k) submissions, which typically have a 90-day FDA review period. For novel, low to moderate-risk devices, they support the eSTAR format, which will be mandatory from October 1, 2025. Additionally, they assist with formal device classification determinations and 180-day Real-Time supplements. Their services are designed to simplify complex regulatory pathways, ensuring that clients receive expert support at every step. The focus on AI and automation aims to increase efficiency and accuracy in regulatory submissions, making the process more manageable for medical device companies.
HQ: Fukuoka, US
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Korean
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Onboarding + annual retainer
Starting from: USD 12,000
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Aoi Regulatory Solutions

Aoi Regulatory Solutions partners with BARDA to advance medical countermeasures, enhancing national health security and preparedness for public health threats.

Aoi Regulatory Solutions is a key partner in the Medical Countermeasures (MCM) initiative, working closely with BARDA (Biomedical Advanced Research and Development Authority) to enhance the nation's public health security and emergency preparedness. They facilitate communication on innovative products and solutions between federal agencies and public stakeholders, supporting the development of critical medical countermeasures from preclinical stages through FDA approval. Their involvement includes supporting BARDA's programs in advanced product development and clinical research, as well as providing flexible and innovative acquisition solutions. This collaboration aims to strengthen U.S. government contracting capabilities to respond swiftly to both known and emerging public health threats, ensuring a robust response to national health security challenges.
HQ: Yokohama, USA
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Korean
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Onboarding + annual retainer
Starting from: USD 12,000
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Kumo Compliance Advisors

Cruxi offers AI-powered regulatory submission services for medical devices, simplifying FDA 510(k), De Novo, and PMA processes with expert guidance and automated compliance checks.

Cruxi provides a comprehensive, AI-powered platform designed to streamline medical device regulatory submissions. They offer 14 distinct services covering both FDA and global market requirements, including FDA 510(k) submissions, De Novo Classification Requests (eSTAR), Q-Submissions, and PMA Supplements. Their intelligent automation, automated compliance checks, and expert guidance aim to simplify complex regulatory pathways from device classification to final submission. For novel, low to moderate-risk devices, Cruxi supports the mandatory eSTAR use for De Novo submissions. They also facilitate formal device classification determinations and offer 180-day, Real-Time supplements with repeatable templates and checklists. The platform is built to handle all your regulatory needs within a single, intelligent system, ensuring efficiency and compliance at every step.
HQ: Kyoto, US
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Chinese
Response SLA: 48 hours
Onboarding time: 10–45 days
Pricing model: Per project
Starting from: USD 8,500
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Hoshi Authorization Bridge

Tsukihoshi offers machine-washable, ultralight, and flexible children's sneakers designed for healthy foot development. Featuring a generous toe box and heel stabilizer for natural movement and balance.

Tsukihoshi is dedicated to developing children's footwear that promotes healthy foot growth and natural movement. Since 1873, their shoes have been designed with a generous toe box, allowing toes to splay naturally, mimic barefoot walking, and enhance grip and balance. This design supports healthy arch development and allows soft bones and cartilage to align naturally. The brand emphasizes stability with a heel counter stabilizer that braces the heel and foot arch, preventing over-pronation and ensuring proper walking. Their "Flex-Joint Outsoles" are extremely flexible, designed to help children's feet flex correctly and promote natural movements. Tsukihoshi shoes are also practical for parents, being machine-washable, quick-drying, and built to withstand repeated washing while maintaining their appearance. The focus on lightweight, flexible, and supportive design makes them ideal for active children, encouraging them to embrace wearing shoes for outdoor adventures.
HQ: Hiroshima, JP
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Korean
Response SLA: 48 hours
Onboarding time: 10–45 days
Pricing model: Per project
Starting from: USD 8,500
View Profile & Get Quote

Tsuru Liaison Gateway

Cruxi offers an AI-powered platform for streamlining medical device regulatory submissions, including FDA 510(k), De Novo, and PMA. They provide expert guidance and automated compliance checks for global markets.

Cruxi provides a comprehensive AI-powered regulatory platform designed to simplify medical device submissions. Their services cover the entire regulatory process, from device classification to final submission packages, for both FDA and global markets. Leveraging intelligent automation and expert guidance, Cruxi aims to streamline submissions for various pathways, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions, and PMA Supplements. The platform offers 14 distinct regulatory services, encompassing automated compliance checks and repeatable templates to ensure efficiency and accuracy. Cruxi is particularly noted for its support in navigating complex submissions like the De Novo Classification Request, which mandates eSTAR use from October 1, 2025. They also assist with formal device classification determinations and real-time supplements, providing a one-stop solution for all regulatory needs.
HQ: Nagoya, US
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Korean
Response SLA: 72 hours
Onboarding time: 14–60 days
Pricing model: Custom pricing
Starting from: USD 6,000
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Kaizen MedTech Advisors

Kaizen MedTech Advisors offers operational excellence and lean consulting, leveraging agile and digital tools to drive strategic results and double-digit P&L impact for clients.

Kaizen MedTech Advisors specializes in operational excellence and lean consulting, employing a holistic approach that integrates agile, digital, and Lean tools. They partner with leaders to achieve outstanding strategic results across operations, marketing, sales, product development, and support functions, aiming for a significant double-digit impact on the P&L. The firm fosters a problem-solving culture at all organizational levels, empowering teams and enhancing their improvement skills through collaborative solution implementation. They also offer specialized AI solutions for the services sector, including personalized marketing, fraud detection, demand forecasting, and customer sentiment analysis, all designed to elevate customer engagement and satisfaction. With a global presence, Kaizen MedTech Advisors is committed to driving continuous learning, growth, and success for their clients worldwide.
HQ: Zug, Switzerland
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Korean
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Retainer
Starting from: USD 20,000
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Nami Device Advisors

NAMI is the nation's largest grassroots mental health organization, offering support, education, and advocacy for individuals and families affected by mental illness.

The National Alliance on Mental Illness (NAMI) is the nation's largest grassroots mental health organization dedicated to building better lives for the millions of Americans affected by mental illness. NAMI provides essential education, advocacy, support, and public awareness programs. They offer resources for individuals seeking help, families looking for support, and those interested in advocating for change in mental health policy and access to care. Their work focuses on promoting recovery, improving community services, and fostering understanding and acceptance of mental health conditions.
HQ: Hiroshima, US
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Chinese
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Onboarding + annual retainer
Starting from: USD 12,000
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Yamato Market Access Group

Yamato Market Access Group is a leading logistics company, #1 in Japan, offering comprehensive supply chain solutions including international freight forwarding, parcel delivery, and customs brokerage. They specialize in e-commerce, automotive, and medical/pharma sectors.

Yamato Market Access Group, operating as Yamato Transport U.S.A., Inc., is a fully owned subsidiary of Yamato Holdings Co., Ltd., recognized as the #1 logistics service in Japan. With nearly a century of experience, the company provides high-quality cross-border business support through a wide range of services. These include logistics, air and ocean freight forwarding, customs brokerage, international moving, and express parcel delivery. Leveraging an extensive global network, Yamato Market Access Group is equipped to handle diverse shipping and import/export needs on a global scale. They offer specialized solutions for various industries, including Electronic Components, E-Commerce, Automotive, Medical/Pharma, and Time/Temperature Sensitive shipments. Their services are designed to maximize transport speed while maintaining high service quality, embodying their commitment to innovation and sustainability. The company's signature TA-Q-BIN service, known for its innovation in urban logistics and last-mile delivery, extends to international parcel delivery. Yamato Market Access Group emphasizes corporate social responsibility, aligning their operations with the communities they serve and focusing on sustainable practices in packaging and delivery. They are a trusted partner for businesses seeking efficient and reliable global logistics solutions.
HQ: Los Angeles, US
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Korean
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Onboarding + annual retainer
Starting from: USD 12,000
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Iroha MedTech Solutions

Iroha MedTech Solutions is a software outsourcing company specializing in designing, developing, and maintaining future-ready software for startups and enterprises. They offer a range of services including MVP development, product engineering, and digital transformation.

Iroha MedTech Solutions, operating as ValueCoders, is a trusted IT partner with over 20 years of experience in software outsourcing. They specialize in engineering future-ready software solutions that deliver results on time and on budget. Their expertise spans from agile MVPs to enterprise-grade platforms, helping startups and enterprises turn ideas into powerful, scalable software. They cater to various roles, assisting early-growth CTOs in reaching product milestones faster with dedicated teams and agile delivery, and enabling scale-stage CTOs to prepare for market expansion. For CROs and technology leaders, they deliver secure, compliant, and scalable solutions that modernize operations without disrupting critical workflows. Their services include Product Discovery, MVP Development, Product Engineering, CTO as a Service, App Development, QA & Testing, and Digital Transformation. With a team of over 675 experts and a track record of serving over 2500 customers, Iroha MedTech Solutions focuses on building scalable products and ensuring a clear ROI from day one. They emphasize gathering requirements, defining scope, and preventing scope creep to ensure successful project outcomes.
HQ: Nagoya, India
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Chinese, Korean
Response SLA: 48 hours
Onboarding time: 10–45 days
Pricing model: Per project
Starting from: USD 8,500
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Kawa RIM Partners

Yaskawa America is a leading global manufacturer of variable frequency drives, servo systems, machine controllers, and industrial robots, known for outstanding quality and reliability.

Yaskawa America, Inc. is a prominent global leader in the manufacturing of variable frequency drives, servo systems, machine controllers, and industrial robots. Their products, whether standard offerings or custom solutions, are highly regarded for exceptional quality and unwavering reliability. The company serves various industries, providing advanced solutions for machine performance and control. Yaskawa America is committed to innovation, as demonstrated by their latest offerings like the Sigma-X servo system, designed to elevate machine performance. They also provide comprehensive pumping solutions for diverse applications. With a strong presence and a focus on customer support, Yaskawa America is a trusted partner for businesses seeking cutting-edge automation and motion control technology.
HQ: Waukegan, US
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Chinese, Korean
Response SLA: 48 hours
Onboarding time: 10–45 days
Pricing model: Per project
Starting from: USD 8,500
Services: MAH, DMAH
View Profile & Get Quote

Rin Authorization Gateway

The Virginia Department of Health Professions licenses and regulates over 500,000 healthcare practitioners across 62 professions to ensure safe and competent patient care. They enforce standards and provide information to practitioners and the public.

The Virginia Department of Health Professions (DHP) is an Executive Branch agency dedicated to ensuring safe and competent patient care. They achieve this by licensing health professionals, enforcing practice standards, and disseminating information to both healthcare practitioners and the general public. DHP comprises Virginia's 13 health regulatory boards, the Prescription Monitoring Program, and the Health Practitioners' Monitoring Program. Collectively, they license and regulate over 500,000 healthcare practitioners across 62 distinct professions. The department also receives complaints regarding Virginia healthcare practitioners who may have violated regulations or laws. Key services include license lookup, complaint filing, and access to consumer information and case decisions.
HQ: Sendai, US
Jurisdictions: JP
Countries: JP
Languages: Japanese, English
Response SLA: 72 hours
Onboarding time: 14–60 days
Pricing model: Custom pricing
Starting from: USD 6,000
View Profile & Get Quote

Matsu Quality Advisors

Matsu Quality Advisors is a provider of educational services, offering a range of associate degrees and certifications. They focus on hands-on learning experiences and personalized academic guidance to help students achieve their career goals.

Matsu Quality Advisors, operating as Mat-Su College, is an educational institution dedicated to providing accessible and quality higher education. They offer various associate degrees, including Associate of Arts and Associate of Science, alongside specialized certifications such as Cisco-Certified Network Associate, Computer Systems and Network Technology, Emergency Medical Technology, General Business, Human Services, and Paramedical Technology. The college emphasizes hands-on learning within simulated healthcare environments for nursing programs and provides comprehensive academic advising to guide students from the beginning of their educational journey through to graduation. Financial aid advisors are available to assist students in navigating funding options, encouraging all eligible students to apply. Mat-Su College is committed to fostering student success through personalized plans and a supportive campus environment with various student clubs and work-study opportunities.
HQ: Mat-Su, US
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Korean
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Retainer
Starting from: USD 20,000
View Profile & Get Quote

Ume Quality Solutions

UMe Credit Union is a community-focused financial institution in Burbank, CA, offering competitive rates and personalized service. As a not-for-profit credit union, earnings benefit members through higher savings rates, better loan rates, and lower fees.

UMe Credit Union, located in Burbank, California, distinguishes itself from traditional banks by prioritizing member relationships and community involvement. As a not-for-profit entity, UMe ensures that its earnings directly benefit its members, translating into more favorable savings rates, loan terms, and reduced fees. The credit union emphasizes a "WOW!" experience, aiming to exceed member expectations through personalized service and a unique, friendly approach. They foster a sense of belonging, treating members as individuals rather than just account numbers, and celebrate their distinct identity within the financial sector. UMe is deeply committed to its local community through its "UMeHelps" initiative. This program actively supports Burbank schools, local organizations, and various charitable causes through donations, volunteer efforts, and fundraising events. Members are encouraged to participate, reinforcing the credit union's philosophy of "U+Me" – working together to build a stronger community.
HQ: Burbank, US
Jurisdictions: JP
Countries: JP
Languages: Japanese, English, Korean
Response SLA: 72 hours
Onboarding time: 14–60 days
Pricing model: Custom pricing
Starting from: USD 6,000
Services: MAH, DMAH
View Profile & Get Quote

GlobalCompliance Solutions Pro

Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.

HQ: Boston, US
Jurisdictions: EU, UK, US
Countries: DE, FR, GB, US
Languages: English, French, German, Spanish
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Custom pricing
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

MedReg International Pro

Specialized regulatory consultancy providing end-to-end compliance solutions for medical devices, IVDs, and combination products across all major markets.

HQ: London, UK
Jurisdictions: EU, UK, US
Countries: DE, FR, GB, US
Languages: English, French, German, Spanish
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Custom pricing
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Regulatory Excellence Partners Pro

Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.

HQ: San Francisco, US
Jurisdictions: EU, UK, US
Countries: DE, FR, GB, US
Languages: English, French, German, Spanish
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Custom pricing
Services: MAH, DMAH
Features: PMDA Support, PMDA Liaison, Translation
View Profile & Get Quote

Comprehensive Buyer's Guide

1. Who Needs Japan MAH/DMAH Services?

Foreign manufacturers placing medical devices on the Japanese market must typically appoint a Japanese Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH).

This requirement applies to:

  • Non-Japanese medical device manufacturers entering the Japanese market
  • Foreign manufacturers needing shonin (approval) or todokede (notification)
  • Manufacturers requiring Japanese regulatory representation
  • Companies needing PMDA support for market entry

Note: The MAH/DMAH must be established in Japan and assumes regulatory responsibility. Japanese language support is typically required for labeling, documentation, and regulatory communications.

2. What Services Are Typically Included?

Japan MAH/DMAH services typically include:

  • Regulatory representation: Acting as your MAH/DMAH for PMD Act compliance
  • Shonin/Todokede support: Assisting with marketing authorization applications
  • PMDA communication: Serving as contact point with PMDA and MHLW
  • Adverse event reporting: Handling incident reporting to PMDA
  • Post-market surveillance: Supporting PMS activities and GVP compliance
  • Translation support: Some providers offer Japanese translation services
  • Compliance support: Ensuring ongoing compliance with PMD Act requirements

3. What Affects Pricing?

MAH/DMAH pricing varies based on:

  • Device classification: Class III/IV devices typically cost more than Class I/II
  • Regulatory pathway: Shonin (approval) is more complex than todokede (notification)
  • Portfolio size: Number of devices and device families
  • Service scope: Basic MAH/DMAH vs. comprehensive regulatory support
  • Translation needs: Japanese translation requirements
  • Contract terms: Annual retainer vs. per-device fees

4. How to Choose a Provider

Key factors to consider:

  • Japanese establishment: Verify they're established in Japan
  • Device class experience: Confirm experience with your device classifications
  • Regulatory expertise: Verify understanding of PMD Act, shonin/todokede pathways
  • PMDA experience: Assess track record with PMDA consultations and approvals
  • Translation capabilities: Check if they offer Japanese translation support
  • Response times: Verify SLA for PMDA communications and incident reporting
  • Additional services: Check if they offer shonin application support or broader consulting

Frequently Asked Questions

Q1: What is a Japan MAH or DMAH?

MAH (Marketing Authorization Holder) and DMAH (Designated Marketing Authorization Holder) are regulatory roles required for placing medical devices on the Japanese market under the Pharmaceuticals and Medical Devices Act (PMD Act). MAH is the entity responsible for obtaining marketing authorization and maintaining compliance for medical devices. DMAH is a specific type of MAH that can be designated by the manufacturer to handle regulatory responsibilities. Key responsibilities include: obtaining marketing authorization (shonin) from the PMDA (Pharmaceuticals and Medical Devices Agency), maintaining marketing authorization and ensuring ongoing compliance, handling regulatory communications with PMDA and MHLW (Ministry of Health, Labour and Welfare), managing post-market surveillance and adverse event reporting, ensuring proper labeling and documentation compliance, and supporting regulatory inspections. The MAH/DMAH must be established in Japan and assumes regulatory responsibility. For foreign manufacturers, appointing a Japanese MAH/DMAH is typically required to place devices on the Japanese market.

Q2: What's the difference between MAH and DMAH?

MAH (Marketing Authorization Holder) is the general term for the entity responsible for marketing authorization. DMAH (Designated Marketing Authorization Holder) is a specific type of MAH that is designated by the manufacturer to handle regulatory responsibilities on their behalf. Key differences: MAH can be the manufacturer themselves (if established in Japan) or a designated third party, while DMAH is specifically a third party designated by the manufacturer. MAH has broader applicability, while DMAH is used when a foreign manufacturer designates a Japanese entity to handle regulatory responsibilities. Both roles involve similar regulatory responsibilities (obtaining shonin, maintaining compliance, etc.), but the designation process and contractual relationships may differ. For foreign manufacturers, both MAH and DMAH services involve appointing a Japanese entity to handle regulatory matters. When evaluating providers, clarify whether they offer MAH or DMAH services and which is appropriate for your situation. Many providers use these terms somewhat interchangeably, but the specific regulatory pathway may differ.

Q3: What affects Japan MAH/DMAH pricing?

Japan MAH/DMAH pricing varies based on several factors: device classification (Class I, II, III, IV—higher risk classes typically cost more due to increased regulatory requirements), regulatory pathway (shonin vs. todokede, different pathways have different complexity and costs), portfolio size (number of devices and device families), service scope (basic MAH/DMAH services vs. comprehensive regulatory support including shonin application, PMS, vigilance, etc.), PMDA interaction requirements (some devices require more PMDA communication and support), surveillance needs (post-market surveillance, adverse event reporting, GVP compliance), change management (frequency of device changes requiring regulatory notifications), and contract terms (annual retainer vs. per-device fees, setup fees, etc.). Some providers also charge for: shonin application support, PMDA consultation fees (which are separate from MAH fees), translation services (Japanese labeling, documentation), and ongoing compliance monitoring. Request detailed pricing breakdowns. MAH/DMAH services can range from a few million JPY per year for simple devices to tens of millions for complex Class III/IV portfolios.

Q4: What should I prepare when onboarding with a Japan MAH/DMAH?

To onboard with a Japan MAH/DMAH, prepare: device information (device names, classifications, intended use, GMDN codes), technical documentation (summaries of technical files, evidence of safety and performance, clinical data if applicable), quality management system information (ISO 13485 certificates, QMS overview), manufacturing information (manufacturing sites, quality controls, manufacturing processes), labeling and IFU (current labeling, instructions for use—may need Japanese translation), existing registrations (if devices were previously on market in Japan, shonin numbers, etc.), and company details (manufacturer information, contact details, etc.). The MAH/DMAH may also request: risk management files, clinical evaluation summaries, post-market surveillance data, and any previous PMDA correspondence. For Japanese market entry, you'll likely need Japanese translations of key documentation. More complete documentation can speed up onboarding, typically 4-8 weeks for straightforward cases. The MAH/DMAH will review your documentation to assess regulatory requirements and provide a quote. Some providers offer pre-onboarding assessments to identify requirements early.

Q5: How do I compare Japan MAH/DMAH providers effectively?

When comparing Japan MAH/DMAH providers, evaluate: Japanese establishment (verify they're established in Japan and can provide Japanese address and contact details), device class experience (confirm experience with your specific device classifications, especially Class III/IV devices), regulatory pathway expertise (understanding of shonin vs. todokede pathways, PMDA processes, MHLW requirements), PMDA relationship (experience with PMDA consultations, track record of successful shonin applications), vigilance and PMS capabilities (adverse event reporting, GVP compliance, post-market surveillance), translation capabilities (if you need Japanese translation support for labeling, documentation), response times (SLA for PMDA communications, change notifications, incident reporting), additional services (some providers offer broader regulatory consulting, shonin application support, etc.), contract terms (flexibility, termination clauses, fee structures), and references (ask about their largest clients, track record, client testimonials). Also consider: their understanding of your industry and device types, their ability to scale support as your portfolio grows, and whether they offer bundled services (MAH/DMAH + translation + regulatory consulting) which can be cost-effective.

Q6: What is the difference between shonin and todokede in Japan?

Shonin (approval) and todokede (notification) are different regulatory pathways in Japan. Shonin is required for Class II, III, and IV medical devices and involves a more rigorous approval process through PMDA, including review of technical documentation, clinical data (for higher risk devices), and quality management system. Todokede is a notification process for Class I devices (lowest risk) and is simpler, typically requiring only notification to the regulatory authority without detailed review. The MAH/DMAH handles both processes, but shonin is more complex and time-consuming. Shonin typically takes 6-12 months or longer depending on device classification and PMDA review, while todokede can be completed in weeks. The MAH/DMAH you choose should have experience with the appropriate pathway for your devices. Most providers support both shonin and todokede, but verify their experience with your specific regulatory pathway.

Q7: Do I need Japanese language support for MAH/DMAH services?

Yes, Japanese language support is typically required for Japan MAH/DMAH services. Key areas requiring Japanese: labeling and IFU (device labels and instructions for use must be in Japanese), regulatory submissions (PMDA submissions, shonin applications, etc. are typically in Japanese), correspondence with PMDA and MHLW (regulatory communications are in Japanese), adverse event reporting (reports to PMDA must be in Japanese), and post-market surveillance documentation (PMS reports, etc. may need to be in Japanese). Many MAH/DMAH providers offer translation services as part of their package or as an additional service. When evaluating providers, clarify: whether translation is included, what documents need translation, translation quality and review processes, and translation costs. Some manufacturers handle translation separately, while others prefer providers who offer integrated MAH/DMAH + translation services for convenience and consistency.

Q8: How long does Japan market entry take with a MAH/DMAH?

Japan market entry timelines vary significantly based on device classification and regulatory pathway: Class I devices (todokede) can take 1-3 months, Class II devices (shonin) typically take 6-12 months, Class III devices (shonin) typically take 12-18 months, and Class IV devices (shonin) can take 18-24 months or longer. Factors affecting timeline include: device classification and risk level, completeness of technical documentation, need for clinical data (higher risk devices require more clinical evidence), PMDA review times (which can vary), quality of your documentation and MAH/DMAH's preparation, need for PMDA consultations (pre-submission meetings can add time but may speed up review), and translation requirements (Japanese translation can add 2-4 weeks). The MAH/DMAH can provide more specific timelines based on your devices and regulatory pathway. Early engagement with a MAH/DMAH can help identify requirements and plan the registration strategy, potentially reducing overall timelines. Some providers offer expedited services, though this typically incurs additional fees.

Related Regulatory Services

EU Authorized Representative (EU AR) UK Responsible Person (UK RP) Swiss Authorized Representative (CH-REP) Person Responsible for Regulatory Compliance (PRRC) EU+UK Cosmetics Compliance DSA Article 13 Representative

Provider Comparison Table

Provider PMDA Liaison Languages Response SLA
Sakura RIM Services JP Yes Japanese 24h
Kizuna MedTech Partners JP Yes Japanese 24h
Shinrai RIM Advisors JP Yes Japanese 24h
Kintsugi Global Advisors JP MAH, DMAH Japanese, English 48h
Hibiki Authorization Partners JP Request quote 48h
Mirai Authorization Gateway JP MAH, DMAH Español, Catalá 72h
Asahi Pharma Services JP DMAH 24h
Takumi Regulatory Advisors JP Yes Japanese 24h
Aoi Regulatory Solutions JP Yes Japanese 24h
Kumo Compliance Advisors JP Yes Japanese 48h

Sources & Official Guidance

Last Updated: 2026-02-04
Reviewed by: Cruxi Regulatory Affairs Team
Cruxi - Regulatory Compliance Services