Requirements for Registration of Medical Device Products in China 2017

Topics

• What are the different regulatory classifications for medical devices?
• Determine device classification
• What are the document requirements for registration for each regulatory classification?
• What does the registration pathway look like for each regulatory classification?
• When are clinical studies required for registration?
• Determine if clinical trials will be needed for your device
• Compile the registration application and Technical Requirement document
• Ascertain the best route to CFDA approval in China
• Coordinate product testing in China
• Is local testing (type testing/sample testing) required for registration?
• Prepare final submissions
• Is approval in the Country of Origin required for registration?
• CFDA Regulatory Approval Process and Timelines

Who should Attend

• Anyone who desire a better understanding or a `refresh` overview of working with State Food and Drug Agency and navigating the regulatory landscape
• All levels of management and departmental representatives
• Regulatory Affairs
• CRO`s
• Clinical Affairs
• RA Specialists
• Compliance
• Quality Control/Quality Assurance
• Distributors/Authorized Representatives
• Marketing & Sales
• Consultants
• Engineering/Technical Services
• Auditors
• Manufacturing