January

January 17, 2019

CFDA Monthly Roundup (December)

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 […]
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 […]
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. […]