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2026 China NMPA Bluebook is here:
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
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
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.
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
Current Regulatory Process and Reform Companies interested in entering the Chinese market for innovative medical devices and treatments must first overcome existing barriers to market
China Biologic Products Holdings, Inc. (CBPO), a public company traded on the NASDAQ, today announced that it acquired 80% equity interest in Tianxinfu Medical Appliance
NORTH ANDOVER, Mass. – October 1, 2017 – China Med Device, LLC (CMD), a leader in helping medical technology companies enter the Chinese marketplace, congratulates
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
WuXi AppTec’s Laboratory Testing Division (LTD) has launched preclinical medical device testing services in China. These services are being offered for Chinese and international clients
So what is the hottest and promising medical device in China? They are neither medical image devices, orthopedic implants, stents and other high-value supplies, nor
Here is the latest CFDA publication about Medical Device Classification Workflow For Overseas Companies: A. The application method Applicants can apply by visiting http://www.nifdc.org.cn/qxbgzx/CL0482/, clicking
For a long time, overseas drug and medical device companies have issues over China’s slow registration and approval process. This could result in delaying market