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February 15, 2019
Monthly CFDA News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), a […]
February 10, 2019
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
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 31, 2019
Do you need assistance in NMPA (CFDA) consultation before initiating your registration? In the areas where it is not clearly defined, it is better to double check your registration questions […]
January 29, 2019
On January 3, 2019, NMPA (CFDA) issued Medical Device Master Files Filing Process (draft) for feedback. Feedbacks need to be submitted by Feb 4, 2019. Medical device master file in […]