GI Endoscopy PMDA Approval & DMAH Support in Japan

GI endoscopy is our core specialty. We handle PMDA device classification, DMAH selection, and clinical evaluation-based approvals for endoscopy accessories and related devices — with English support for overseas manufacturers.

GI Endoscopy Regulatory Affairs in Japan

GI endoscopy devices range from accessories to reprocessing equipment, each with distinct regulatory requirements. MK Consulting brings deep expertise and a proven track record in this field, providing optimal submission strategies tailored to each product. We have experience with leading domestic and international manufacturers, and provide strong support for overseas manufacturers entering the Japanese market.

Device Categories We Cover

Accessories & Instruments

Biopsy forceps, polypectomy snares, hemostatic clips, EMR/ESD devices. We cover both single-use and reusable devices.

Our GI Endoscopy Expertise

Extensive submission track record for endoscopy accessories
In-depth knowledge of PMDA guidance specific to GI endoscopy devices
Specialization in clinical evaluation-based approvals (no new clinical trials required)
Industry insights from working with leading domestic and international manufacturers
English support for overseas manufacturers

Frequently Asked Questions

How are GI endoscopy accessories classified under Japanese pharmaceutical law?

Most accessories are classified as Class II (controlled medical devices), but some may fall into Class I or Class III depending on product characteristics and risk profile. MK Consulting reviews your product specifications and recommends the optimal classification and application pathway.

How can I sell an overseas-approved endoscopy accessory in Japan?

Japan requires a manufacturing and marketing approval (or certification) under the Pharmaceutical and Medical Device Act. By leveraging existing overseas clinical data and technical documentation through a clinical evaluation approach, it is often possible to obtain approval without new clinical trials.

Are the application requirements different for single-use and reusable devices?

Yes, they differ significantly. Single-use devices require sterilization validation and packaging integrity testing, while reusable devices require verification of cleaning and sterilization procedures. We propose submission strategies tailored to your product's intended use.

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Clinical trials are the biggest barrier to entering the Japanese market. However, if conditions are met, you can obtain marketing approval using a Clinical Evaluation Report without new clinical trials.

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