Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Cobridge Co., Ltd.
Tokyo, Japan
We assist medical device companies with the medical device registration and approval in Japan. Regulatory consulting services and DMAH services for foreign manufacturers to enter Japanese market.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
February 26, 2025
Approximately 5 minutes
Japan Specialty Fulfillment for Medical Devices: Low Volume, High Value Sales
Specialty Fulfillment Services for the Japanese Market
For medical device manufacturers, especially those with low volume, high value or innovative products, standard Third-Party Logistics (3PL) solutions may be inefficient. Specialty Fulfillment services in Japan offer a focused approach to manage the import, storage, and distribution of these products, allowing the manufacturer to retain greater control over sales and profit margins.
Target Customers and Scenarios
Specialty Fulfillment is typically ideal for manufacturers who:
- Target a limited number of initial customers (e.g., under 15 high-end hospitals).
- Sell high-value or innovative/high-risk products.
- Seek significantly higher profit margins than those offered by traditional distributors.
- Drive demand using internal sales resources but require local logistics support.
- Are implementing a one-off or low-volume sales strategy.
Role of the Independent License Holder
The Specialty Fulfillment service is often provided in conjunction with an Independent License Holder (such as a Designated Market Authorization Holder or D-MAH) who handles the necessary administrative and logistics functions on behalf of the manufacturer. This allows the manufacturer to bypass the complexities of setting up a complete local subsidiary.
Key logistical functions managed include:
- Customs Clearance: Handling the import process and customs requirements.
- Warehouse Storage: Storing the medical devices in compliant facilities.
- Fulfillment: Processing and delivering orders to the customers.
- Invoicing and Collections: Managing the financial aspects of the sales process in Japan.
Strategic Advantages
By utilizing specialty fulfillment, manufacturers can achieve:
- Increased Revenue Control: Keeping a larger portion of the revenue stream compared to selling outright to a traditional distributor.
- Pricing Flexibility: Having greater control over product pricing in the Japanese market.
- Sales Process Control: Maintaining control over direct customer relationships and sales strategies, while outsourcing the physical logistics.
Related Articles
Approximately 5 minutes
Japan Medical Device Registration: Pathways and Requirements
The medical device registration process in Japan is overseen by the PMDA and varies significantly based on device classification (Class I to IV). Key pathways include Pre-Market Submission (PMS), Pre-Market Certification (PMC), and Pre-Market Approval (PMA).
Approximately 5 minutes
Japan Medical Device Local Labeling Requirements: Tempu Bunsho
Medical device labeling in Japan, specified by PMDA's Article 52, mandates the use of Japanese 'tempu bunsho' (package inserts/IFUs). This process involves rigorous content requirements, notification upon revision, and MAH/DMAH oversight for affixation.
Approximately 5 minutes
Japan Medical Device Post-Market Surveillance (PMS): GVP and Adverse Event Reporting
An overview of Japan's PMS requirements under the PMD Act, focusing on the MAH's GVP compliance, the mandatory reporting of adverse events (Fuguai), and the strict reporting timelines (e.g., 15 days for death or serious, unanticipated events).
Approximately 5 minutes
Japan Adopts Regulatory Reliance: Priority Review for US FDA-Authorized Devices
Japan’s **MHLW** has introduced a major policy shift (Cabinet Order No. 362 of 2025) allowing **Priority Review** for medical devices that already hold **US FDA authorization**. This reliance aims to accelerate market access, but strict conditions apply concerning the device class, **JMDN Code**, and key properties matching an existing Japanese predicate device.