June 12, 2019 | 1:00 PM - 02:00 PM EDT
The session will cover China post market surveillance (PMS). NMPA (CFDA) has started to put more emphasis on post market supervision than ever before. Three key areas will be discussed: adverse events (AE), recalls and overseas inspection. Two key regulations were issued in the past year on AEs and overseas inspection. We will cover key requirements of the regulations, discuss its implications on foreign companies, and how foreign companies can take a more proactive role to comply under the new PMS environment in China. Best practice example on overseas inspection will be shared.
Decree No.1 for Medical Device Adverse Event Reporting and Reevaluation issued on August 31st was implemented January 1st, 2019. For the 1st time, NMPA (CFDA) imposed severe penalties for violations. On December 28th, 2018, National Medical Products Administration (NMPA) issued ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018) implemented from the date of publication. Provincial NMPA (CFDA) offices will take major responsibility for surveillance whereas overseas inspection responsibility resides at the national NMPA (CFDA) office.
Topics to be covered include:
- What are the current status of AE and recalls?
- What are the requirements and penalties for AE reporting?
- What should foreign companies do to comply with China new PMS requirements?
- What is the best practice for overseas inspection from preparation to on-site inspection to post inspection follow up?
- What are the requirements for NMPA (CFDA) recalls?
Grace Fu Palma
Founder, China Med Device
Grace brings 20+ years of industry experience to the medical device industry. She has extensive management experience in marketing, business development, partnerships, and international commercialization from large multinational corporations (Hewlett Packard Medical Products Group, Phillips Healthcare) to start-ups (Teratech Corp). As the founder of the Chinese American Heart Association in 2005, she built the 500-member leading cardiovascular clinicians and scientists’ society with Chinese origins. The combination of cross-cultural mentality and deep Sino-U.S. medtech knowledge and professional experience in China and the United States has enabled CMD to help more than 50 medtech companies with their China entry and growth since its inception. Grace is originally from Beijing, China and graduated with a Bachelor’s degree from Beijing University and an MBA from Yale University.
Vy H. Tran, J.D.
Senior Vice President, Regulatory Affairs and Quality Assurance, Varian Medical Systems
Vy H. Tran has been with Varian Medical Systems since 1998. In her current role as the vice president of regulatory affairs and quality assurance, Tran oversees quality systems compliance, quality assurance, internal audits, document control, post market surveillance reporting and quality systems training for all of the company’s manufacturing sites worldwide. She is also responsible for the regulatory clearance and approval strategies to ensure that new products are accessible to a global market in a timely manner. Vy holds a Bachelors of Science from Santa Clara University and a Juris Doctorate from Lincoln Law School of San Jose.