Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017

Topics

• In Japan, are medical devices required to be registered before they can be sold?
• Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
• What are the different application categories for medical device registration?
• What are the different regulatory classifications for medical devices?
• What are the document requirements for notification for the various classes of medical devices?
• What does the registration pathway look like for each regulatory classification?
• Is local testing (type testing/sample testing) required for registration?
• What are other requirements that are necessary for approval in addition to the device application?
• Is approval in the Country of Origin required for registration?
• When are clinical studies required for registration?

Who should Attend

• Clinical Project Managers
• Clinical Research Associates
• Clinical Investigators and Clinical Research
• Regulatory Affairs Professionals
• Regulatory Affairs Specialists
• Regulatory Affairs Management
• Auditors
• Regulatory Project Leads/SME`s
• Clinical Affairs
• Compliance Specialists
• Consultants
• Quality Assurance
• Distributors