By 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.
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In the final installment of this 3 part series, the author describes the final Clinical Literature report.
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, Part III
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- Webinar: Order 650 – China’s New CLE Requirements for Medical Devices89Gain 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…
- Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective, Part II: Selecting the Best Clinical Literature80By Richard Conforti, M.S., Nerac Analyst, Originally Published: June 14, 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 2…
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