Online Webinar 2019 - Live Webinar Regulatory Requirements for Registration of Medical Device Products in China

Overview
Entering the Chinese market offers tremendous opportunity for medical device companies, but it is not without challenges. Although China’s medical regulatory bodies are becoming more harmonized with international standards, the Chinese registration process still poses significant difficulties for Western medical device and pharmaceutical firms. The China Food & Drug Administration (CFDA) is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in each province. Medical devices require CFDA registration prior to being sold in China
Who will Benefit
All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of working with State Food and Drug Agency and navigating the regulatory landscape.
• CRO’s
• Regulatory Affairs
• RA Specialists
• Clinical Affairs
• Quality Control/Quality Assurance
• Compliance
• Marketing & Sales
• Distributors/Authorized Representatives
• Engineering/Technical Services
• Consultants
• Manufacturing
• Auditors
Session Highlights
• Determine device classification
• What are the different regulatory classifications for medical devices?
• What does the registration pathway look like for each regulatory classification?
• What are the document requirements for registration for each regulatory classification?
• Determine if clinical trials will be needed for your device
• When are clinical studies required for registration?
• Ascertain the best route to CFDA approval in China
• Compile the registration application and Technical Requirement document
• Is local testing (type testing/sample testing) required for registration?
• Coordinate product testing in China
• Is approval in the Country of Origin required for registration?
• Prepare final submissions
• CFDA Regulatory Approval Process and Timelines
Who will Benefit
All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of working with State Food and Drug Agency and navigating the regulatory landscape.
• CRO’s
• Regulatory Affairs
• RA Specialists
• Clinical Affairs
• Quality Control/Quality Assurance
• Compliance
• Marketing & Sales
• Distributors/Authorized Representatives
• Engineering/Technical Services
• Consultants
• Manufacturing
• Auditors
SPEAKER:
David R. Dills, Global Regulatory Affairs & Compliance Consultant, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.