CFDA Updates

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

CFDA Released 9 Technical Review Guidelines

On September 28th, CMDE issued 4 medical device technical review guidelines for comments 1.     Drug Eluting Coronary Stent System Preclinical Study Technical Review Guideline. 2.     Mobile Medical Device Registration Technical […]
November 7, 2017

China’s State Council: Official Opinions On Deepening the Review and Approval Policies Reform and Encouraging Drug And Medical Device Innovations

On October 8, in a government news conference in Beijing, the State Council issued the “Opinion on Encouraging the Innovation of Drugs and Medical Devices by Deepening the Reform of […]
November 2, 2017

China and U.S. Agencies Met to Further Their Drug Medical Device Regulatory Cooperation

  China and U.S. Agencies Met to Further  Their Drug Medical Device Regulatory Cooperation Recently, CFDA’s International Cooperation Bureau in conjunction with the Center for Drug Evaluation, the Verification Center, […]
October 19, 2017

China to Speed Up Approvals Of New Drugs and Medical Devices By Accepting Overseas Trial Data

China is looking to speed up approvals for new drugs and devices and plans to accept data from clinical trials carried out overseas, a potential huge benefit  for both international […]