September 18, 2018
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 7, 2018
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
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
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 […]