Procedures for Entering the Japanese Medical Device Market MDREX JAPAN is the Japanese subsidiary of MDREX KOREA,
From strategic planning at every stage of your entry into the Japanese market
We provide systematic support for licensing, insurance listing, distribution, and post-market management.

• Design customized market entry strategies considering product characteristics and the Japanese healthcare environment
• Support determination of medical device applicability through the Ministry of Health, Labour and Welfare and PMDA
• Class classification and equivalent product investigation via JMDN
• Develop a roadmap through market analysis, competitor assessment, and insurance system evaluation
• Conduct KOL surveys in Japan and provide introductions

• Utilize consultation systems such as SaMD unified consultation, general consultation, pre-development consultation, and clinical trial necessity consultation to coordinate with regulatory authorities on product class, generic name, and the need for clinical trials
• Support strategy formulation and preparation of materials for PMDA pre-consultation
In Japan, such pre-consultations are extremely important, so it is essential to provide regulatory authorities with a thorough explanation of the product and obtain the necessary responses, even if it takes time.

• Respond to PMDA safety and efficacy reviews as well as manufacturing site quality management (JGMP) inspections
• Review compliance with GCP for submitted clinical trial data
• Classify products based on equivalence to already approved devices
　- New Medical Device: A device with new intended use, effect, operating principle, or performance; submission of clinical trial data is mandatory
　- Modified Medical Device: A device with improved performance or effects compared to existing products; clinical evaluation of the modified features is required
　- Generic Medical Device: A device substantially equivalent to an existing product; simplified procedures can be applied

• Based on Japan’s prohibition of mixed medical practice, insurance listing strategy is critical for successful market entry.
　- For products classified as A (comprehensive) or B, existing medical fees are applied.
• Support for C1/C2 listing strategies, cost-effectiveness analysis, and insurance price determination
• Assistance with consultations with the Ministry of Health, Labour and Welfare and securing economic and clinical evidence
• Support for obtaining and submitting KOL opinion letters within Japan

• Support for introducing distributors and building a distribution network based on insurance claim volumes, medical institution channels, and economic analysis
• Execution of local marketing and sales strategies in collaboration with Japanese partner companies