September 4, 2018

Key Points to Navigate the Class III Medical Device Type Testing – Part 1 Performance Testing

China’s guideline requires that the Class III medical device registration must submit a test report, and the test report should be issued by a certified medical device testing center. The […]
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 […]
August 27, 2018

2nd Round UDI Feedback Requested By CFDA

CFDA announced Unique Device Identification (UDI) draft plan for feedback on August 22, to adequately identify medical devices through their distribution and use. When fully implemented, the label of all […]