Blogs

September 19, 2018

New Trends in Medical Artificial Intelligence – Part 1

At present, artificial intelligence technology is increasingly mature and permeates all walks of life, among which the deep collection of artificial intelligence and medical treatment has brought new changes to […]
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 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 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 […]