ERCP-Related Devices
For cannulas, guidewires, dilators, stone retrieval baskets, stone extraction balloons, and similar products, review the intended use, structure, contact site, and method of use.
Regulatory Points for GI Endoscopy Medical Devices in Japan
For ERCP-related devices, biliary and pancreatic stents, EUS-related devices, and endoscopic accessories, the applicable generic name, class, application route, and required documentation can differ depending on intended use, structure and principle, patient contact, whether the device remains in the body, and other characteristics.
Related case study: Support for approval of a pancreatic duct stent
This article summarizes the regulatory points to review when submitting gastrointestinal endoscopy-related medical devices in Japan.
The Application Route Cannot Be Determined by the Product Name Alone
Even products referred to by the same terms—such as "stent," "guidewire," or "catheter"—may have different regulatory positions if their intended use, anatomical site, structure, implantation period, materials, or other characteristics differ.
First confirm the product specifications and clinical use, and then review the Japanese generic name, JMDN code, class, and whether an applicable certification standard exists.
Based on that information, organize whether the likely route is a marketing notification, certification, or approval.
Main Product Groups
Biliary and Pancreatic Stents
Review the material, implantation site, implantation period, shape, whether the stent is covered, delivery system, and other characteristics, and organize the required performance and safety evaluations.
EUS-Related Devices
For EUS-FNA/FNB needles, EUS-BD devices, drainage stents, and similar products, review differences between the new procedure or intended use and existing Japanese generic names and approved indications.
Endoscopic Accessories
For biopsy forceps, snares, ESD knives, hemostatic clips, injection needles, and similar devices, review intended use, single-use or reusable status, sterilization, materials, method of operation, and other characteristics.
Five Items to Confirm for Approval or Certification
Generic Name and JMDN Code
Review the intended use, anatomical site, structure, whether the product remains in the body and for how long, and other factors to identify the applicable generic name and JMDN code.
Class and Application Route
Confirm the class assigned to the generic name and whether a certification standard exists and applies, then organize the likely route among marketing notification, certification, and approval.
Comparable Approved or Certified Products
Identify products with similar intended use, structure, materials, performance, method of use, and clinical position, and organize the differences from the proposed product.
Nonclinical Testing and Clinical Evaluation
In addition to strength, durability, delivery performance, biological safety, sterilization, and other testing, consider the need for literature, overseas clinical data, or a clinical trial depending on the novelty of the product.
Reimbursement
Consider whether the product may fall under specified reimbursable medical materials, its relationship to existing functional categories, and the possibility of a new functional category together with the intended use and product characteristics defined in the regulatory application.
From Product Information Review to Application Preparation
- 01
Confirm the Intended Use and Product Specifications
Organize how the product will be used in clinical practice.
- 02
Confirm the Generic Name and JMDN Code
Compare the definition with the product characteristics and identify candidate generic names.
- 03
Confirm the Class and Application Route
Also confirm whether a certification standard exists and whether the product falls within its scope.
- 04
Organize the Required Evaluations and Testing
Based on differences from approved products, identify the points that need to be addressed in performance, safety, and clinical evaluation.
- 05
Prepare the Application Documentation
Prepare the application form, STED, test documentation, clinical evaluation, and other materials according to the selected application route.
Clinical Use Is Particularly Important for Biliary and Pancreatic Devices
For biliary and pancreatic stents and EUS-BD-related devices, the regulatory assessment is influenced not only by product structure but also by factors such as:
- Placement site
- Implantation period
- Intended procedure
- Delivery method
- Removal or exchange method
- Differences from existing treatment
It is important to organize the application strategy based not only on the product specification but also on an understanding of how the device will actually be used clinically.
Frequently Asked Questions
Does a Biliary Stent Follow the Same Application Route as an Existing Approved Biliary Stent?
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Not necessarily. Differences in intended use, material, structure, implantation period, delivery system, and other characteristics should be reviewed.
Can an ERCP Product Sold Overseas Be Submitted in Japan Without Changes?
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Overseas documentation may be usable, but the product still needs to be reviewed against the Japanese generic name, JMDN code, certification standard, intended use, and other requirements.
How Do We Determine Whether a Clinical Trial Is Required?
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Review the product's novelty, differences from approved products, nonclinical testing, literature, overseas data, and other evidence, and organize the clinical issues that need to be explained in the application.
Official Sources
For Japanese generic names, JMDN codes and review information on approved medical devices, refer to the following official sources.
Contact Us About GI Endoscopy and Biliary/Pancreatic Medical Devices
We review the clinical use and specifications of the product and organize the Japanese generic name, application route, and required documentation.
Regulatory support for GI endoscopy devices