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Learn to Comply With China's UDI Submissions Requirements

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Learn to Comply With China's UDI Submissions Requirements

This is an On-demand recording from December 2020.

 

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 will explain how they work in practice for UDI submission to NMPA and what to expect going forward.

Key Highlights:

·        What is the scope of requirements for UDI submission in China?

·        UDI implementation impact on public tendering and volume purchasing

·        Learn about key policies, regulations, and standards

·        Understand the key components of UDI regulations

·        Become familiar with the NMPA UDI pilot and UDI database

·        Clarify the difference between FDA’s and China’s UDI requirements

·        Learn best practices and key takeaways for overseas manufacturers

 

Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

 

Upon conclusion of the program, you will:

·        Understand the timeline and key updates for China UDI regulation.

·        Understand China’s new UDI requirements and UDI database

·        Learn best practices for UDI submission in China

 

Who should attend?

·        Clinical affairs professionals

·        Managers in the life sciences industry

·        Regulatory affairs professionals

·        Quality affairs professionals

·        Medical affairs professionals

·        R&D managers

·        Compliance managers

·        Operations managers

·        Marketing and business executives

·        Chief financial and commercial managers

 

Speakers

 

Grace Fu Palma,

CEO, China Med Device LLC

Grace brings 20+ years of MedTech and diagnostic industry experience. She is the CEO of China Med Device (www.ChinaMedDevice.com) with offices in Beijing, Hainan and Boston, providing turnkey solutions for western medical device/IVD/CDx products companies to enter China with NMPA (CFDA) regulatory and clinical affairs (RA, QA, CER, RWD, CRO etc.) services. The company has processed 1,000+ NMPA certificates and accelerated 250+ Chinese and western companies’ success. A seasoned bilingual and bicultural MedTech executive, she has held a variety of marketing, operational and strategic development management positions at both large multinationals and startup companies. She specializes in China NMPA (CFDA) regulatory (RA/QA/CRO/CER) and commercialization services. In addition, she founded the Chinese American Heart Association (500+ cardiovascular clinical professionals) in 2005. She is a regular speaker at key national and local MedTech meetings and a frequent contributing writer to multiple regulatory journals. Grace grew up in Beijing, China and received a BA degree from Peking University, China, and an MBA from Yale University in New Haven, CT. 

 

 

Kate Liu Jing

Cook (China) Medical Trading Co. Ltd

QA Director

Kate has more than 20 years’ quality and regulatory compliance management experience and 11 years’ management representative role (QA and RA Head, rich project management experience in projects regarding product registration, product launch, and quality system globally). She is strong in quality system management and familiar with regulatory compliance of ISO13485, cGMP, and medical device GSP; NMPA Regulation, FDA 21CFR Part 820; MHLW-Japan, ANVISA-Brazil; TGA; Good at regulatory standards and compliance requirements at expert level in class I, II, and III medical device  manufacturing , submission requirements and post market surveillance; Mainly focus on quality, regulatory and compliance activities in manufacturer site, commercial office, distribution center, and R&D center; Involved in global and regional quality system projects in global and Asia Pacific region.

 

Derek Yao

Head of international sales and international regulatory affairs

Apex Medical

Since graduating from University, Derek have been engaged in medical device industry for 8 years.

When he was in Medtronic Kanghui, he was responsible for the registration of the orthopedic implants in the global market, the products have been successfully approved in Russia, India, Egypt, Brazil, Argentina, Pakistan, Iran etc. He also took part in several times of CE audit and ANVISA audit.

After join Apex Medical, he was responsible for the registration of insulin pump and infusion sets in the global market, the products have been successfully approved in Russia, India, Argentina, Pakistan, Israel etc. He also finished several OEM projects with our European Partner. In 2017 successfully develop and get the CE certification for the first Ambulatory Infusion Pump in China.

He also work as a consultant for another two companies (one is in sports medicine, the other is artificial joint) to help them get CE certification especially on Clinical Evaluation.

 

Alex Jiang

global commercial quality director

Smith & Nephew plc

Alex Jiang, global commercial quality director, previously APAC quality director in Smith and Nephew. He has the overall responsibility for Quality Management in Research & Development, Manufacturing, and distribution and sales in this region. He has distinctive understanding of global unique device identification (UDI) system under the global regulatory framework for medical devices, with his particular expertise of computer pattern recognition. He actively participates in promoting and developing the regulations and standards for the identification of medical devices. He has the systematic experience for labeling conversion, product registration information management and inventory management software systems. To meet the requirements of global UDI regulations, he built the integrated system, associating the standard process for product registration and the requirements of UDI, to control all kinds of labeling conversions, which has been certified under ISO13485 quality management system certification.

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