Requirements for Registration of Medical Device Products in China 2017 is a webinar that covers topics such as:
- 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
Requirements for Registration of Medical Device Products in China 2017 is intended for:
- 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
