overseas

February 10, 2019

Overseas Inspection Results in Jan: Big Players Cited

NMPA (CFDA) published two groups of overseas inspection results on Jan 18 and Jan 30. 17 overseas medical device and IVD manufacturers were cited, including some big players, BD, Boston […]
February 8, 2019

ChinaMed Device Cited by RAPS on Overseas Inspection

On January 18, 2019, NMPA (CFDA) announced the first batch of Overseas Inspection Results in 2019. Five foreign manufacturers, including BD and Rayner, were cited with 24 observations. Grace Palma, CEO of […]
January 11, 2019

NMPA (CFDA) Must Read: Acceptance of Overseas Clinical Data

NMPA (CFDA) issued Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices on January 11th, 2018. A year later, we revisit this important guideline to remind foreign medical […]
July 31, 2018

Overseas Inspection: There are Defects CFDA Chasing

Following the 13th Five Year Plan (2016-2020), CFDA has conducted overseas inspection covering all imported high-risk medical devices. Since November 2017 when CFDA began to publish overseas inspection results, 24 […]
July 17, 2018
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Webinar on CFDA Oversea Inspection– It’s time to take it seriously!

Are you ready for CFDA’s oversea inspection? Do you comply with Chinese Medical Device Good Manufacturing Practice? Does your current quality system meet the Chinese legal requirements? Join us for […]