By Richard Conforti, M.S., Nerac Analyst,
Originally Published: April 19, 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 this 3 part series, the author explores the new regulations, and ways to address changes in the registration process.
Want to read the rest of the article? Fill out the form to download:Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective
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- 92Gain 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…
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