RAMED China Medical Device Regulatory Forum
Date: July 28, 2018 @ 2:00 pm – @ 5:00 pm
Location: Hanqi Investments (1633 Bayshore Highway, Suite 280, Burlingame, CA 94010)
The medical device regulatory reform in China is changing the pattern and future of the enterprises and the whole industry at an unprecedented pace.
What benefits will the enterprises gain from the reform? How should the enterprises understand and make use of these regulatory advantages?
RAMED China medical device regulatory forum, with its team of experts having years of regulatory experience and coming from world famous medical device firms, will share the up-to-date CNDA requirements with you.
Agenda：
2:00PM - 2:30PM Check-in, onsite registration and networking
2:30PM - 5:00PM Seminars
Titles of Seminars
1. Organizational development for medical devices administration in China
Speaker: Chang Yongheng, Chief Advisor of RAMED. This presentation will share main changes of responsibilities from CFDA to CNDA, a newly organized SAMR duties.
2. To be a winner by regulatory solution for innovative medical devices in China
Speaker: Ellen Jiang, Founder of RAMED. This topic contents of both how CNDA regulates innovative medical devices and how applicant strategically design solution for application.
3. CNDA requirement update for medical devices pre-market approval
Speaker: Christine Jiang, Co-founder of RAMED. Christine will share the newly published CNDA revised draft on medical devices regulation, and what industry can be benefited from this reform.
4. CNDA acceptance for overseas clinical data
Speakers: Christine Jiang & Ellen Jiang. This presentation helps understanding the applicability of clinical data conducted out of China for CNDA registration purpose, and possible options to avoid duplication in clinical trial.
5. China medical device market characteristics
Speaker: Jane Shen. The following contents will be included in this presentation: 1) The number of clinical organizations, classification and their characteristics as a buyer. 2) Sales model, tendering policy and price as well as internet-based new medical system.
Speakers Introductions
Yongheng Chang
- Yongheng Chang is the executive chairman of the China International medical device regulatory forum (CIMDR) of the CCFDIE of CNDA.
- He was director of product registration division of the department of medical devices of SFDA (State Food and Drug Administration),
- Mr. Chang was deputy counsel of the department of medical devices of SFDA, and deputy director general of CCFDIE of CFDA (China Food and Drug Administration) successively.
Ellen Jiang, Founder of RAMED
- Ellen has twenty-two years of experience in China regulatory affairs and compliance for medical devices.
- She was director of regulatory affairs & compliance for BD China (1996-2010) and Thermo Fisher Scientific (2012-2015).
- She is currently member of the 5th SAC/TC136 (national standardization technical committee for clinical laboratory and in vitro diagnostic test system),
- She is the 1st SAC/TC338/SC1 (national standardization technical committee for measurement control and electrical equipment safety laboratory.
Christine JIANG, Co-founder & Regulatory Affairs Director
- Ms. Jiang has 12years+ RAQA working experience in Danaher Leica Microsystems and Thermo Fisher Scientific.
- She has extended experience in active medical device CNDA registration.
- She had worked closely with oversea manufacturer and China local manufacturer for registration strategies.
- She is familiar with ISO 13485, ISO 9001. ISO 9001 Lead auditor.
Jane Shen, Senior Consultant
- Ms. Shen has 20 years+ hands on and leadership experience in China and other Asian markets in medical devices filed.
- Her achievements include work with R&D in product development and building premium brand images for international suppliers at local level.
- She has established highly productive commercial team and distribution networks.
Please register online. Online registration is free. Onsite registration is $10.
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