The Choice for Outsourcing
Your Trusted Partner
for Medical Device Market Entry in Japan
Support for Medical Device Sales Business
Outsourcing of Marketing Authorization Holder（MAH）operations
Outsourcing of Logistics and Medical Device Remanufacturing
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Extensive
Track Record（DMJ: more than 100 items）
（Suzuyo: 70 companies） -
Multiple Locations
（Specialized in Medical）
（6 locations in Japan） -
High Quality
（ISO13485 certified）
Please consult with us now
for anything related to medical devices in Japan
Contact
Medical Device Applications for registration, Arrangements of Import, Outsourcing
of MAH / DMAH, Warehouse Services, etc.
For consultations regarding entering the medical device industry, business improvement, or outsourcing, click here.
-
For Companies,
considering entering
medical device industry -
For Companies,
already handle medical devices
and considering outsourcing
Do you have any of these concerns?
-
"What licenses are required?"
"What procedures are necessary?"
"What are the required conditions?" -
"I found a good medical device
and want to sell in the
Japanese medical device market." -
"We want to bring
our medical devices
to the Japanese market." -
"We operating QMS in-house,
but to be honest,
the burden is too great,
so we want to outsource it." -
"Where should I request
import customs
for medical devices?" -
"We need a storage location
registered for medical devices,
but space is insufficient." -
"We want to focus on
our core activities such as
new product development,
exploration, and sales." -
"We need inspection &
packaging in clean room
but investing in equipment
is challenging."
Achievements of DMJ & Suzuyo
-
Achievements of
Outsourcing of MAH / DMAH
（Partial）- （USA）-ClassII/Electrocardiogram Monitor
- （USA）-ClassII/Single-Use Endoscope Injection Needle
- （China）-ClassII/Multi-Parameter Monitor
- （China）-ClassII/Ultrasound Diagnostic Device
- （South Korea）-ClassII/Electronic Stethoscope
- （South Korea）-ClassIII/Dental Implant System
- （South Korea）-ClassIII/Total Hip Prosthesis
- （USA）-ClassIII/Bladder Ureteral Reflux Treatment Injection Material
- （USA）-ClassIV/Human Amniotic Membrane Tissue Healing Material
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Achievements of
Medical Device Logistics
（Partial）- Surgical Kits
- Respiratory Products
- Stoma Care Products
- Dental Equipment
- Blood Gas Analyzers
- Welfare Equipment
- Orthopedic Implants
- Catheters
- Ultrasound Diagnostic Contrast MediumInjectors
The four solutions of DMJ & Suzuyo
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01Regulatory Affairs and
（Designated）Marketing Authorization Holder Delegation
For companies new to the medical device industry or foreign manufacturers without a MAH license in Japan, DMAH MEDICAL JAPAN Co., Ltd.（DMJ）provides comprehensive support from medical device regulatory applications to Marketing Authorization Holder delegation as DMAH or MAH.
DMJ holds the international certification ISO13485 and assist in promptly and reliably bringing a wide range of medical products, from Class I to Class IV in Japan, -
02Procurement and Logistics
When importing products from overseas to Japan, companies must obtain import permission from Japanese customs. Suzuyo’s affiliated company,Suzuyo Customs Co., Ltd., handles customs procedures for import permission. Customs brokers with expertise and experience in customs laws and related regulations manage these processes. Additionally, Suzuyo are certified as an AEO （Authorized Economic Operator）by the customs director,ensuring security management and regulatory compliance in our daily customs operations. Also Suzuyo offers maritime and air cargo services,including receiving cargo from shipping companies on behalf of the consignee and delivering it to the specified location.
Suzuyo has a strategic partnership with UPS（United Parcel Service, Inc）, allowing to leverage their network for overseas support and door-to-door services. For transporting products from domestic manufacturing sites to our warehouse, Suzuyo’s affiliated company, Suzuyo Cargo Net Co., Ltd., provides optimized transportation solutions with a network of 43 locations and over 2,200 trucks nationwide, tailored to customer needs. -
03Operations
Suzuyo holds the international ISO13485 certification and has provided medical device warehouse services for over 70 medical device manufacturers. We have established an independent quality assurance department and conduct ongoing education and training for staff under a QMS management system. Our specialized staff, focused on medical device handling, provides high-quality services, including cleaning and packaging of pre-sterilized medical devices and inventory management of rental medical devices, tailored to customer needs.
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04Optimal Logistics Sites
Suzuyo uses a unique simulation system to analyze and propose optimal locations for cost and lead time. By relocating warehouse hubs closer to delivery destinations,you will reduce delivery distances and shorten lead times. Shorter delivery distances improve delivery quality by reducing tasks at intermediate points and lowering delivery costs. Multiple locations can be operated for BCP（Business Continuity Planning）and lead time reduction.
Contact
Medical Device Applications for registration, Arrangements of Import, Outsourcing
of MAH / DMAH, Warehouse Services, etc.
For consultations regarding entering the medical device industry, business improvement, or outsourcing, click here.
Customer Testimonials
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"It was our first time handling medical devices, but they helped us with everything from regulatory approval to inventory management and delivery, which was a great help."
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"We no longer need to bear the labor costs of the so-called three key roles required for MAH, which has been a great relief."（Japanese Company）"
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"We have become more flexible in responding to significant increases in volume, andthrough continuous improvement proposals, safety, quality, and productivity haveimproved."
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"By consolidating manufacturing outsourcing and warehousing at one location, we have streamlined the logistics flow and reduced delivery lead times."
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"We greatly appreciate your support in handling everything from regulatory approval and inventory management to delivery for our first experience dealing with medical devices."
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"I became interested in starting using DMAH system and contacted D-MAH Medical Japan to proceed actual DMAH agency projects. After that, I was introduced to Suzuyo, and we were able to proceed with the entire business, including logistics, as a one-stop solution."
Steps for Outsourcing Marketing Authorization Agency（DMAH / MAH）& Logistics
FAQ
- How do I import medical devices?
- Generally, organizations（companies or individuals）need a Marketing Authorization Holder（MAH）license. Additionally, different regulatory procedures are required depending on the product（notification / certification / approval）. However, it is possible to have a MAH delegation company handle this for you without obtaining the license yourself. D-MAH MEDICAL JAPAN Co.,Ltd,,a（D）MAH delegation company, offers a one-stop service that includes regulatory application procedures in collaboration with its group companies.
- Can you handle both Japanese and overseas products?
- Yes, we can handle both. It is also possible for foreign manufacturers to become the regulatory license holders for their products（keyword: Special Approval System for overseas companies, using "DMAH" ）. Please contact us for more details.
- What does delegating of Marketing Authorization Holder involve?
- A MAH license is required for marketing medical devices in Japan and operating this license requires significant human resources. By delegating this responsibility to a MAH delegation company, you can bring medical devices to market without obtaining the license yourself. This delegating service can include the daily operations of QMS（Quality Management System）and GVP（Good Vigilance Practice）.
- Can you explain medical device manufacturer as a storage house in detail?
- Medical devices are regulated under the Pharmaceuticals and Medical Devices Act（PMDA）in Japan, and obtaining a license is necessary for manufacturing medical devices. The manufacturing process for medical devices includes design, main assembly, sterilization, and final product storage within Japan. A registration for medical device manufacturing is required at the locations where these activities are carried out.Suzuyo is a registered medical device manufacturing warehouse and is entrusted with manufacturing operations by medical device manufacturers and distributors. Suzuyo is mainly entrusted with packaging and labeling operations, such as inspection and labeling of medical devices.
- What kind of QMS have you established?
- We have obtained ISO13485:2016 certification and implement management practices that meet both QMS regulatory requirements and ISO standard requirements. For more details, please feel free to contact us.
- What classes of medical equipment can you handle?
- We can handle all medical devices from Class I to Class IV.
Contact
Medical Device Applications for registration, Arrangements of Import, Outsourcing
of MAH / DMAH, Warehouse Services, etc.
For consultations regarding entering the medical device industry, business improvement, or outsourcing, click here.