Nov 24, 2020   SOURCE: PR NewsWire

FDAnews and CenterWatch Announce -- Medical Device Clinical Trials in China: Latest Regulatory Developments Webinar Dec. 10, 2020

FALLS CHURCH, Va., Nov. 24, 2020 /PRNewswire-PRWeb/ -- Medical Device Clinical Trials in China:
Latest Regulatory Developments
An FDAnews/CenterWatch Webinar
Thursday, Dec. 10, 2020, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/mdctchina

What is the best pathway for getting a medical device approved in China?

Real-world data/evidence (RWD/E) evolved significantly in 2020, proving initial clinical use in real-world settings can take place in months, not years for China's National Medical Products Administration (NMPA)-unapproved devices.

Savvy devicemakers are using the latest regulatory developments to their advantage, drawing on key factors for China's clinical strategy and pathways to support their submissions, updates on the RWD pilot program to reduce their clinical trial costs and time to market, while considering crucial elements in using overseas clinical data.

Will you be one of them?

In this webinar, Grace Fu Palma, CEO of China Med Device, LLC and Jason Zhang, MD, its Clinical Director, will share what one must know and use to do just that: 

    --  Different clinical pathways and how to decide which pathway to choose to
        support the NMPA medical device/in vitro diagnostic (IVD) regulatory
        submission or postmarket surveillance
    --  Key areas one needs to pay attention to so as to have the right strategy
        and tactics to shorten clinical trials and approval times
    --  Find out whether devices qualify for the real-world data/study Hainan
        program, and how to get into the program
    --  Key considerations on the feasibility and justification of overseas
        clinical data acceptance
    --  Strategies to improve the overall contract research organization (CRO)
        process and get new products to the Chinese population faster --
        clinical trial study design and clinical trial protocol, calculation of
        sample size, on-site management and data integrity

Once one understands these regulatory developments, one can reduce clinical trial costs and get devices to the Chinese market faster.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Medical Device Clinical Trials in China:
Latest Regulatory Developments
An FDAnews/CenterWatch Webinar
Thursday, Dec. 10, 2020, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/mdctchina

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/mdctchina
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

About CenterWatch:
Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

Media Contact

Michelle Butler, FDAnews, 703.538.7600, mbutler@wcgclinical.com

SOURCE FDAnews