CFDA Updates

September 27, 2018

China Med Device Exhibits at RAPS Annual Conference

Visit China Med Device at RAPS October 1 – 4th in Vancouver and Get the Latest Update on NMPA (formerly CFDA) and a Glamor Shot! China Med Device, LLC is […]
September 10, 2018
CFDA guidelines

A Record of Changes Marked August CFDA

Monthly CFDA News Roundup (August) 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 […]
September 4, 2018

CFDA Accelerates Effort in Post Market Surveillance – 1st Decree on Adverse Event Reporting and Reevaluation

NMPA (CFDA), part of SAMR (State Administration of Market Regulation), issued Decree No.1 for Medical Device Adverse Event Reporting and Reevaluation on August 31st.  More control, strictness and timely post-market […]
September 3, 2018

Key Points for Registering Drug-Device Combination Products in China

From 2009 to the present, a total of 138 products have been applied for classification, and nearly one-third of the products were applied in 2017 and 2018. The market for […]
August 29, 2018

CFDA: 99 Device Standards to be Revised in 2018 – Huge Impact on Renewals and New Registrations

CFDA announced “2018 Medical Device Industry Standard Revision Plan” on August 7th to make device regulations more consistent and stringent with international standards. It is the finalized version of the […]