Blogs

September 18, 2018

CEO of China Med Device Chairs Panel at AdvaMed

We are pleased to announce Grace Fu Palma, CEO of China Med Device, LLC, was selected to chair the opening panel of China Regulatory and Reimbursement Environment during The MedTech Conference […]
September 10, 2018
CFDA guidelines

A Record of Changes Marked August NMPA (CFDA)

September 7, 2018

Key Points to Navigate the Class III Medical Device Type Testing – Part 2 Biological Testing

Biological testing points 1. Preparation of testing materials Technical requirements, specifications are equivalent to performance testing. The contracts may be different, it needs to be cleared in advance. 2. Identify […]
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 […]