UDI data requirement expert Gary Saner of Reed Tech and China regulatory consultants Hamish King and Victoria Caldy of Cisema will discuss best practices for manufacturers to comply with current and emerging UDI and medical device registration mandates in China, especially in light of recent new draft regulations expanding the product scope for China UDI requirements.
In this webinar, we will cover the following subjects:
• UDI regulatory framework
• UDI implementation plan
• UDI, label, and IFU requirements
• Customs clearance and NMPA inspections
• How Reed Tech and Cisema can help
Bring your questions. We will also provide a table of the required data attributes and other key takeaways in the slides. Get started now! UDI preparation can be complex and time-consuming without subject-matter expertise.
Learn best practices and recent learnings for UDI preparation and compliance and modify your global UDI strategy to incorporate local representatives, as well as understand China Regulatory Health Authority updates to UDI timelines and requirements.
Who Should Attend
• Regulatory Affairs/Operation Leaders
• Product Managers and Business Analysts
• Manufacturing, Operations, and Supply Chain Leaders
• Quality Leaders
• IT Support
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech, is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.
Hamish King is COO at Cisema, a regulatory consultancy and CRO for China founded in Munich and Beijing in 2002. A lawyer by training - admitted in Hong Kong and NSW, Australia - Hamish previously worked with UK Magic Circle Firm Linklaters in Hong Kong, and has over 10 years' experience in the legal and regulatory fields. He has obtained the RAC and CFA qualifications. Regularly writing articles and speaking on China regulatory pathways and registration points, Hamish is originally from Sydney but has lived in Hong Kong for over 7 years.
Victoria Caldy is Business Development & Marketing Director at Cisema. From major multinationals to small start-ups, Victoria has over 20 years’ experience providing Life Sciences clients with planning and strategy for product launches, regulatory approvals, and registrations. Her broad expertise includes building a class III medical device company from the bottom-up, providing her with hands-on experience to better serve and solve the challenges of getting to the China market.