Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017 is a webinar that covers topics such as:
- 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?
Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017 is intended for:
- 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
