Blog

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 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 […]
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 […]
August 17, 2018

In One Day, 17 Industry Standards Released by CFDA

On August 6, CFDA published 17 industry standards, covering sterilization of infusion device, biological testing, and standardization of medical consumables. 1.       Test methods for packaging of sterilized medical devices: Breathable […]
August 17, 2018

Problems and Suggestions for Medical Device Clinical Auditing in China

In conjunction with the problems audited by the CNDA for clinical trials of medical devices, China Med Device, LLC summarizes some common problems and put forward some suggestions.   Clinical […]
August 16, 2018

Major Leadership Demotion at NMPA (CFDA) Today