ABOUT SERVICE
We bring the world’s products to the Japanese market as a reliable bridge.
We enable overseas manufacturers to navigate Japan’s regulatory landscape and successfully introduce their products.
To market medical devices in Japan, registration and approval by the Pharmaceuticals and Medical Devices Agency (PMDA) is required. As a Designated Marketing Authorization Holder (DMAH), we act as the authorized representative for foreign manufacturers, providing comprehensive support in regulatory compliance, submission preparation, and quality system implementation.
Our track record includes successfully introducing Israeli-made ventilator masks and Taiwanese dental mirrors, establishing us as a trusted partner for the companies entering the Japanese market.
Strengths
Regulatory Support Executed with Practical Expertise
From classification and notification strategy to JMDN/UDI assignment, STED creation, QMS assessment, and GVP implementation, we provide end-to-end regulatory support. We act as a seamless bridge between overseas manufacturers and the PMDA, minimizing operational burden and accelerating market entry.
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Strength#01
Extensive Approval and
Submission Experience
We have supported PMDA submissions across a wide range of medical devices, including masks and dental instruments. Our team can propose strategic submission pathways tailored to each product’s characteristics, ensuring efficient and compliant registration.
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Strength#02
Regulatory Expertise with
Specialized Teams
Our staff are highly knowledgeable in Japanese Medical Device Regulations (PMD Act, ISO) standards, and related frameworks, ensuring smooth market introduction for foreign manufacturers.
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Strength#03
Comprehensive,
One-Stop Support
From preparation and translation to regulatory correspondence and post-market follow-up, we offer full-spectrum support. This minimizes your workload and accelerates time-to-market.
Achievements
Diverse Products and countries,
Proven Track Record
We have extensive experience introducing a variety of devices, including ventilator masks and dental equipment, across multiple regulatory classes. Our operational expertise spans:
Optimizing intended use
Identifying applicable standards
Ensuring labeling and instructions comply with Japanese requirements
Post-market safety management, including complaint handling and recall planning
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Track Record #01
Rapid Market Entry for Infectious Disease Control Products
We registered Israeli-made ventilator masks in compliance with the Pharmaceuticals and Medical Devices Act.
Responding to urgent domestic demand, we achieved rapid market introduction within a short timeframe. -
Track Record #02
Supporting Entry of Dental Devices into Japan
We supported the market introduction of German dental motors in Japan.
Providing end-to-end support from regulatory application to sales,
we expanded options available to the dental industry. -
Track Record #03
Experience Across Device Classifications
We handle products ranging from Class I general medical devices to Class II controlled medical devices.
We develop and executes approval strategies aligned with each product’s regulatory classification.
Bringing Global Innovation to Japan
As a trusted partner delivering innovative overseas medical devices to the Japanese market, we continue to expand our proven track record.
Leveraging our domestic expertise, we also aim to introduce Japan-origin technologies to the global market in the future — serving as a bridge for global medical solutions.