Gain a working knowledge of the clinical literature evaluation process for China in the Nerac webinar hosted by FX Conferences: Order 650 – China’s New CLE Requirements for Medical Devices
Click here to register.
In 2014 the Chinese FDA updated its regulations for medical devices, Order 650, under which manufacturers are now required to perform and submit a formal review of the clinical literature. These updates have dramatically increased expectations for successfully applying for and ultimately obtaining approval to market and sell a medical device in China.
This presentation provides attendees with an overview of the clinical literature evaluation process, helps them understand the requirements, and provides tips on things to consider when conducting the evaluation of the clinical literature. Our speaker discusses the selection of predicate devices, creating the search protocols, what goes into the analysis of clinical literature, and sections of the final report.
Key learning points for attendees:
- How to create a clinical literature evaluation to comply with Order 650 and the CFDA
- Choosing a predicate device
- Components of the predicate device table
- Understanding the sections of Annex 6 and Annex 7 in the clinical literature evaluation process
- How to choose and analyze appropriate clinical literature
- The sections of the final report and the content that can be found there
Join Nerac Regulatory analyst Rich Conforti for this powerful discussion designed to give you the insights and information you need on the new CFDA regulatory proposals/guidances.
Be sure to register to attend!
Who should attend?
If you are a VP/Director of Regulatory or Clinical Affairs, VP/Director of R&D, VP/Director of Marketing, Product Manager or Quality Management System Representative, you don’t want to miss this webinar!
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- 89By Richard Conforti, M.S., Nerac Analyst, Originally Published: August 15, 2016 In 2014 the Chinese Food and Drug Administration, CFDA, updated their regulations on medical devices. These updates substantially changed the way in which a medical device company, particularly international companies not based or founded in China, registers their devices in China. In the final…
- 81By Richard Conforti, M.S., Nerac Analyst, Originally Published: April-August, 2016 In 2014 the Chinese Food and Drug Administration, CFDA, updated their regulations on medical devices. These updates substantially changed the way in which a medical device company, particularly international companies not based or founded in China, registers their devices in China. In part 1 of…