inspection

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 4, 2019

NMPA (CFDA) Must Read—— New Guideline for Oversea Inspection

On December 28th, 2018, National Medical Products Administration (NMPA) issued ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018) implemented from the date of publication. […]
December 14, 2018

9 Clinical Trials Have Compliance Issues in NMPA Inspection

In order to strengthen the management of medical devices clinical trials, the National Medical Products Administration(NMPA, formally CFDA) launched the Notice of First Batch Medical Device Clinical Trial Inspection Results […]
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 […]