Ask the Experts:
Comply with the China Class II
Medical Device UDI Deadline in June!

Recorded April 23, 2024

Register to view the recording

Ask the Experts:
Comply with the China Class II
Medical Device UDI Deadline in June 

Ask the Experts:

Comply with the China Class II
Medical Device UDI Deadline in June

This free webinar will focus on the China NMPA upcoming UDI deadline for Class II medical devices. Keeping up-to-date and compliant with China’s regulations can be difficult. The upcoming UDI deadline a few months away will impact your ability to import and distribute medical device products in China. As a manufacturer, you need to ensure you and your local agent are prepared and comply with the regulations on time. Experts from Cisema, a local NMPA-qualified legal agent, and Reed Tech, a leading global UDI data management provider, will share their experiences with meeting previous China UDI deadlines and how to successfully meet the upcoming one. The China medical device compliance pathway is unique and intricate – you don’t want to miss this event to help plan a clear course to compliance.

Key Takeaways: 

  • Identify What Medical Devices are in Scope
  • Learn China’s UDI Requirements and Timing
  • Learn how UDI fits into a broader regulatory compliance framework for medical devices in China
  • Understand China’s UDI Related Rules and Processes for Importers
  • Learn the UDI Data Attributes and Registration Methods for the NMPA Database

Who does this apply to:

  • Global Strategy Business Managers
  • Regulatory Affairs/Operation Leaders
  • Product Managers and Business Analysts
  • Manufacturing, Operations, and Supply Chain Leaders
  • Quality Leaders
  • IT Support

For a customized demonstration: MedDevice@ReedTech.com, +1-215-557-3010

Learn more about our panelists below.


  • Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech


  • Hamish King, CEO, Cisema
  • Victoria Caldy, Business Development & Marketing Director, Cisema
RT - LS - 20210713 - Headshot - Gary Saner Reed Tech Color GreenBG 768x831 - IMG
Gary Saner

Gary Saner is a Sr. Manager of Information Solutions in the Reed Tech Life Sciences group. He is a subject matter expert on Drug Labeling, Medical Device UDI, and other structured content reporting to regulatory agencies and commercial organizations. He has over 40 years of experience in software development, process management, and data administration, with the last 19 years focused on the Life Sciences industry. With a deep understanding of regulations, business requirements, and systems, he has helped shape and implement successful solutions at Reed Tech for data management, validation, processing, and submission of Drug Labeling content, Cosmetic information, and Medical Device UDI data. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team.

Hamish King
Hamish King

Hamish King is the CEO of 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 8 years.

Victoria Caldy
Victoria Caldy

Victoria Caldy is Business Development & Marketing Director at Cisema. From major multinationals to small start-ups, Victoria has over 20 years of 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.

Learn more about our panelists: 

cisema_logo@2x (1) (1)

+852 6468 6239 / + 1 773 449 5169


Cisema is a CRO (clinical research organization) and turnkey regulatory affairs solutions provider for the China and Hong Kong markets, with a large on-the-ground contingent of local Chinese staff and satellite sales offices around the world, with a special focus on China product registration. In China, certain product groups require compulsory registration (e.g. NMPA, CCC, CEL, CML) before they can be imported, traded, and used. 

Cisema is the largest consultant company in the EU for regulatory affairs in China, with an increasing number of customers in the US, Japan, Korea, and Israel.

Cisema expertise includes the NMPA (formerly known as CFDA) registration for medical devices, IVDs, pharmaceuticals (DMF), cosmetics, health food, and other life sciences products. 

For more information, please visit Cisema.com.

LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.

For more information, please visit ReedTech.com.

Life Sciences Solutions Driven by Accuracy and Insight
Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry's data. Our offerings smooth the collection, transformation, submission, and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.