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2024 China NMPA Bluebook is here:
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
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
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
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
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
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 access and navigate an uncertain
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 Co., Ltd. from PW Medtech
NORTH ANDOVER, Mass. – October 1, 2017 – China Med Device, LLC (CMD), a leader in helping medical technology companies enter the Chinese marketplace, congratulates its client, Promaxo, Inc., on
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, and
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 who need to pass product
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 IVD products and wearable devices,
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 into the “medical device classification
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