MDiT Forum and Regulation Summit 2013

Key Topics

• Registration & regulations of medical devices
• Current situation analysis and future trend of medical device regulations in China
• Chinese regulations to medical device manufacturers and suppliers
• Good Manufacturing Practice (GMP) for medical devices and Process Validation Guide Guidance
• Innovation of material: application of ultra-high molecular weight polyethylene (UHMWPE) in medical devices
• Innovating with quality: a new theme in medical device development
• Unique Device Identifier (UDI) in the whole medical device industry
• Submission of Pre-market Approval (PMA) for Class III medical device
• Integrating regulatory into the Quality System and conduct quality control
• Medical device integration using current wireless infrastructures
• Risk analysis techniques and methodology for medical device

Who should Attend

• Medical Devices Manufacturers
• Doctors/Clinicians
• Materials
• Machine Tool Suppliers
• Medical OEMs
• Medical Packaging
• Health IT Providers
• R&D Outsourcing
• Research Institutes
• Assessment Agencies