GI Endoscopy Specialty Service

GI endoscopy is our core specialty. We have deep expertise in the regulatory requirements for endoscopy accessories and related devices. We also welcome inquiries about other medical device categories.

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.

Reprocessing Equipment

Automated endoscope reprocessors, storage cabinets. We have expertise in infection control and disinfection efficacy evaluation.

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