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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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
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
Understand the key components of UDI regulations
Become familiar with the NMPA UDI pilot and UDI
Clarify the difference between FDA’s and China’s
Learn best practices and key takeaways for
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:
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
Marketing and business executives
Chief financial and commercial managers
Grace Fu Palma,
CEO, China Med Device LLC
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,
Medical Trading Co. Ltd
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.
Head of international sales
and international regulatory affairs
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
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.
global commercial quality
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.