Insight Regulatory Consulting, LLC
Japanese Medical DEvice Regulatory Consulting
薬事関連業務支援
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Pharmaceuticals & medical Devices Law
Keeping up with ever-evolving designs and functions of medical devices, regulations that ensure the safety and effectiveness of medical devices are evolving at an increasing speed. Even with harmonization efforts, there are country-specific differences. Making mistakes in the regulatory process can delay product launch or incur unnecessary cost. When it comes to making a submission in Japan, your application and all of the supporting documents need to be in Japanese. Your success starts with careful investigation of your regulatory pathway and proper understanding of relevant Japanese regulations, PMD-Act, QMC Ordinance, etc.
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▶ Product Registration
承認 Pre-Market Approval (Class IV, III, de novo, and Class II without MHLW-designated technical standard)
認証 Certification by Third-Party Notified Body (Class II and III with MHLW-designated technical standard)
届出 Notification (Class I)
承認 Pre-Market Approval (Class IV, III, de novo, and Class II without MHLW-designated technical standard)
認証 Certification by Third-Party Notified Body (Class II and III with MHLW-designated technical standard)
届出 Notification (Class I)
▶ Manufacturer registration
▶ QMS-compliance assessment
▶ Regulatory pathway strategy building
▶ Technical translation & interpreting
Insight Regulatory Consulting has over 20 years of experience in medical device regulatory submission work and over 30 years in technical translation and interpreting. We are focused on the goals of our clients, sensitive to their business needs, and committed to teamwork.
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▶ QMS-compliance assessment
▶ Regulatory pathway strategy building
▶ Technical translation & interpreting
Insight Regulatory Consulting has over 20 years of experience in medical device regulatory submission work and over 30 years in technical translation and interpreting. We are focused on the goals of our clients, sensitive to their business needs, and committed to teamwork.
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Sayoko Kuwahara, Principal
Born in Osaka, educated at Boston University (1987), and currently located in Boise, ID.
Email: Kuwahara@Insight-Company.com ● Tel: 425-785-8182
Born in Osaka, educated at Boston University (1987), and currently located in Boise, ID.
Email: Kuwahara@Insight-Company.com ● Tel: 425-785-8182