{"id":2,"date":"2025-09-12T16:13:30","date_gmt":"2025-09-12T07:13:30","guid":{"rendered":"https:\/\/www.mdrex.co.jp\/?page_id=2"},"modified":"2025-10-08T11:07:58","modified_gmt":"2025-10-08T02:07:58","slug":"expansion","status":"publish","type":"page","link":"https:\/\/www.mdrex.co.jp\/en\/expansion\/","title":{"rendered":"Procedures for Entering the Japanese Market for Medical Devices"},"content":{"rendered":"
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Formulation of Market Entry Strategies<\/div>
\u2022 Design customized market entry strategies considering product characteristics and the Japanese healthcare environment
\r\n\u2022 Support determination of medical device applicability through the Ministry of Health, Labour and Welfare and PMDA
\r\n\u2022 Class classification and equivalent product investigation via JMDN
\r\n\u2022 Develop a roadmap through market analysis, competitor assessment, and insurance system evaluation
\r\n\u2022 Conduct KOL surveys in Japan and provide introductions<\/div><\/div><\/div>
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Implementation of PMDA Pre-Consultation<\/div>
\u2022 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
\r\n\u2022 Support strategy formulation and preparation of materials for PMDA pre-consultation
\r\n- In Japan, such pre-consultations are extremely important. Therefore, it is essential to provide the regulatory authorities with a thorough explanation of the product and obtain the necessary feedback, even if the process takes time.<\/div><\/div><\/div>
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Applications for Approval\/Certification<\/div>
\u2022 Respond to PMDA safety and efficacy reviews as well as manufacturing site quality management (JGMP) inspections
\r\n\u2022 Review compliance with GCP for submitted clinical trial data
\r\n\u2022 Classify products based on equivalence to already approved devices
\r\n\u3000- New Medical Device: A device with new intended use, effect, operating principle, or performance; submission of clinical trial data is mandatory
\r\n\u3000- Modified Medical Device: A device with improved performance or effects compared to existing products; clinical evaluation of the modified features is required
\r\n\u3000- Generic Medical Device: A device substantially equivalent to an existing product; simplified procedures can be applied<\/div><\/div><\/div>
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Insurance Listing Applications and Strategy Development<\/div>
\u2022 Based on Japan\u2019s prohibition of mixed medical practice, insurance listing strategy is critical for successful market entry.
\r\n\u3000- For products classified as A (comprehensive) or B, existing medical fees are applied.
\r\n\u2022 Support for C1\/C2 listing strategies, cost-effectiveness analysis, and insurance price determination
\r\n\u2022 Assistance with consultations with the Ministry of Health, Labour and Welfare and securing economic and clinical evidence
\r\n\u2022 Support for obtaining and submitting KOL opinion letters within Japan<\/div><\/div><\/div>
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Domestic Sales \/ Distribution in Japan<\/div>
\u2022 Support for introducing distributors and building a distribution network based on insurance claim volumes, medical institution channels, and economic analysis
\r\n\u2022 Execution of local marketing and sales strategies in collaboration with Japanese partner companies<\/div><\/div><\/div><\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":75,"parent":0,"menu_order":1000,"comment_status":"closed","ping_status":"open","template":"page__lp.php","meta":{"footnotes":""},"class_list":["post-2","page","type-page","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t