Biliary & Pancreatic Endoscopy Devices
MK Consulting brings deep specialized expertise in biliary stents, ERCP devices, and EUS-BD devices, providing end-to-end PMDA approval support from regulatory strategy to market authorization.
Biliary stents, ERCP devices, and EUS-BD devices are representative products in the gastrointestinal endoscopy field. MK Consulting brings deep knowledge of this device category and provides comprehensive regulatory support from strategy development to approval. Note that PMDA applies consistent, fair review standards across all device categories. Our strength lies in our specialized expertise in biliary and pancreatic devices, enabling us to propose efficient, well-founded regulatory strategies. For products already approved overseas, we leverage existing clinical data through a clinical evaluation approach to pursue approval without new clinical trials.
Metal and plastic biliary stents, biliary drainage devices. Regulatory support for products indicated for obstructive jaundice and biliary strictures.
ERCP catheters, EST knives (papillotomy knives), basket-type stone retrieval devices, balloon dilation devices, and related accessories.
Devices for endoscopic ultrasound-guided biliary drainage (EUS-BD), including EUS-CDS and EUS-HGS procedures.
Pancreatic duct stents and pseudocyst drainage devices.
We review your product specifications, overseas approvals, and intended use to propose the optimal regulatory pathway.
We develop a clinical evaluation approach, STED structure, and testing plan tailored to your product.
We prepare PMDA-compliant technical documents in Japanese, including translation and adaptation of overseas documents.
We manage the full submission process and respond to PMDA queries throughout the review.
After approval, we support GQP/GVP system setup and DMAH licensing.
Biliary stents are generally classified as Class III (specially controlled medical devices). However, classification may vary depending on the product's structure, materials, and intended use. We review product specifications in detail to propose the optimal classification.
Timelines vary by product class and approval pathway. Using a clinical evaluation approach with existing overseas approval data can help shorten the timeline. Please contact us for details specific to your product.
Yes, several EUS-BD devices have received PMDA approval in recent years as the procedure has gained widespread adoption. MK Consulting stays current with the latest approvals and can propose an efficient regulatory strategy based on precedent cases.
Japan requires marketing authorization under the Pharmaceutical and Medical Device Act. By leveraging your CE marking clinical data through a clinical evaluation approach, it is possible to pursue PMDA approval without conducting new clinical trials in Japan.
Start with a free consultation. We will propose the optimal regulatory strategy for your product.