November

November 30, 2017

In-depth Analysis of China’s Rapidly Growing Point of Care Test Industry

China’s Point of Care Testing industry: A billion-dollar market and growing 20-30% annually The rapid growth of the Point of Care Testing Industry and the obvious advantages of primary medical institutions […]
November 30, 2017

China’s In Vitro Diagnosis (IVD) Market Overview

China’s In Vitro Diagnosis (IVD) Market is an opportunity for U.S. companies to take their product offering overseas. Here is a current overview of the current market. Introduction In vitro […]
November 28, 2017

EYE TECH CARE’s Glaucoma Treatment Product Receives CFDA Approval

EYE TECH CARE, a French medical device company, has received approval from CFDA to begin marketing its EyeOP1® glaucoma treatment product in China. The first non-invasive medical device approved for […]
November 27, 2017

Registration is open! Meeting CFDA Representatives from Medical Device Evaluation Center in Boston.

China Med Device cordially invites you to our latest regulatory event in Boston on December 10th, 2017 and the opportunity to meet face to face with two prominent China FDA […]
November 24, 2017

The 2017 CBIIC Conference Was Held Successfully

The 2017 China BioMed Innovation and Investment Conference (2017 CBIIC) was held in Suzhou China lately. It was co-hosted by Securities Association of China (SAC), China Pharmaceutical Innovation and Research […]
November 22, 2017

CryoLife’s BioGlue® Clinical Trial Is Underway In China

CryoLife, a US-based medical device and tissue processing company focused on cardiac and vascular surgery, announced that enrollment has started in the company’s BioGlue clinical trial in China.  The results […]
November 22, 2017

BREAKING NEWS: CFDA Is Proposing 6 Major Changes to Its Medical Device Regulations

CFDA just released a Solicitation for Public Comments (SPC) for its proposed amendment of the Medical Device Regulations (MDR), as mandated by a recent order from the Chinese State Council. […]
November 20, 2017
high blood pressure

China’s High Blood Pressure Epidemic

According to a recent market study conducted in China, over a third of Chinese adults are now suffering from high blood pressure. To make matters worse, only 5% of those […]
November 17, 2017

Guidelines for Further Reform Registration Reviewing and Approval to encourage medical device/drug Innovation

On October 8th, China State Council released guidelines for Further Reform Registration Reviewing and Approval to encourage medical device/drug innovation for comments. The guidelines contain 36 provisions for 6 key […]
November 17, 2017

CFDA Released a New Notice about “The Related Work for Regulating the Medical Device Classification.”

On October 10th, the CFDA released a new notice about “The Related Work for Regulating the Medical Device Classification.” Here are the highlights: 1.     For new medical devices that have […]
November 17, 2017

Technical Requirements for Accepting Oversea Clinical Trial Data (Draft)

On October 20th, CFDA released the new technical requirements for accepting overseas clinical data for comments. This technical requirement is based on the guidelines from Further Reform Registration Reviewing and […]
November 17, 2017

CFDA Released and Implemented the 3rd Batch of “Medical Device Clinical Trial Exemption List”.

On October 31st, the CFDA released and implemented the 3rd batch of “Medical Device Clinical Trial Exemption List”. There are 37 Class II, 11 Class III medical devices and 116 […]