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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
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
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
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
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
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