Blog

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 […]
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 6, 2017

About China Medical Device Market Entry

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 […]
November 4, 2017

M&A News In China Medical Device Market: CBPO Acquires Tianxinfu

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 […]
November 3, 2017

China Med Device Helps Promaxo Secure Key Funding and Distribution Partner

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 […]
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, […]
November 1, 2017

WuXi AppTec Launches Local Medical Device Testing Services in China

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 […]
October 25, 2017

What Will Be The Next Hottest Medical Device In China?

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, […]
October 24, 2017
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CFDA Medical Device Classification Workflow For Overseas Companies

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 […]