China NMPA Medical Device Regulatory, Registration & UDI Submission
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WEBINAR
China NMPA Medical Device Regulatory, Registration & UDI Submission

Recorded March 9 2021 | 11 AM EST

Learn more about China NMPA Medical Device Regulatory, Registration & UDI Submission

Key Points:
• Best practices and recent learnings for China NMPA UDI preparation
• Update on UDI timelines and requirements
• Leveraging UDI data internally/externally
• Learn about key policies, regulations, and standards
• Become familiar with the NMPA UDI pilot and UDI database
• What is the scope of requirements for UDI submission in China?

UDI data requirement experts Gary Saner and John Lorenc of Reed Tech and guest speaker Grace Fu Palma CEO, China Med Device, LLC discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers for China NMPA regulatory processes.

This webinar recording gives key updates concerning the China medical device market including regulatory requirements, registration and UDI timelines by class. We answer questions concerning medical device registration scenarios, data elements and requirements. The speakers review and provide clarity on currently posted guidance and answer questions concerning China NMPA.

To keep up with international standards and help device manufacturers prepare for regulatory compliance, China’s National Medical Products Administration (NMPA) issued a number of regulations related to unique device identifiers (UDIs) and launched its new UDI database portal. The first group of medical devices, which includes high-risk implantable devices, is now mandated to submit UDI data to the database.

In this webinar, you will get an overview of key UDI-related regulations, lessons learned from the first batch pilot, and guidance on how to comply with requirements. Our experts explain how they work in practice for UDI submission to NMPA and what to expect going forward.

Who should attend?

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

Speakers

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

Gary Saner 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.

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John Lorenc, Director Product Management, Medical Devices, Reed Tech

John directs electronic submission and regulatory requirement initiatives that impact the medical device industry. He has advanced experience with machine-to-machine submission requirements to global UDI databases, including US FDA GUDID, EU EUDAMED, and China NMPA UDID. John represents Reed Tech in membership with MedTech Europe, and actively participates in electronic submission pilots to regulator UDI databases.

grace

Grace Fu Palma, CEO, China Med Device, LLC

Grace, a seasoned medtech executive, specializes in helping U.S. medical device companies to accelerate their regulation & commercialization in China. With 20+ years of experience driving product strategy, regulatory approval, business and channels partnership and market development for both large multinationals and startup companies, she held a variety of marketing, operations and strategic development management positions. Bi-lingual, bi-cultural and deep Sino-U.S. medtech connections and practical knowledge and experience. Founder of Chinese American Heart Association (CnAHA) in 2005.

Reed Tech is the provider of best-in-class information-based solutions and services to meet the needs of the life sciences industry, government agencies, and the intellectual property market. Our customers are located throughout the world and include a wide range of medical device manufacturers and pharmaceutical companies, the U.S. government, numerous Patent Authorities, and IP-driven companies and law firms. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis company.

For more information: MedDevice@ReedTech.com, +1-215-557-3010

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