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NMPA (CFDA) published 2018 Medical Device Registration Report on May 31. ChinaMed Device compiled the data and made four charts to illustrate the current trend for imported devices in China. I. Domestic V.S Imported Imported Class III medical devices and IVDs outnumbered domestic Class III, for the first time, since the publication of Registration Report in 2015. For our comments
NMPA (CFDA) published 2018 Medical Device Registration Report on May 31. ChinaMed Device compiled the data and made four charts to illustrate the current trend for imported devices in China. I. Domestic V.S Imported Imported Class III medical devices and IVDs outnumbered domestic Class III, for the first time, since the publication of Registration Report in 2015. For our comments
Primarily due to the pressing problem of doctor shortage, the Chinese government is eagerly encouraging medical use of Artificial Intelligence. Currently, China has two kinds of license for AI medical devices: One is assistive, which aids healthcare professionals in their provision of care, and the other is diagnostic: like the consultation room of the future, they act as a virtual
Primarily due to the pressing problem of doctor shortage, the Chinese government is eagerly encouraging medical use of Artificial Intelligence. Currently, China has two kinds of license for AI medical devices: One is assistive, which aids healthcare professionals in their provision of care, and the other is diagnostic: like the consultation room of the future, they act as a virtual
On March 1st, 2019, Grace Palma, CEO of China Med Device, is interviewed by BioWorld MedTech about the revised registration guidelines for medical devices. With revised registration guidelines, China moves closer to harmonization By Elise Mak, Staff Writer HONG KONG – This week, China reported a plan to revise the registration guidelines for medical devices to facilitate product registration for med-tech
NPMA (formerly CFDA) published the “Clinical Exemption Catalog for Medical Devices” yesterday (Sep 30th), in which a total of 855 medical devices and 393 IVDs exempted from clinical trial. It is the effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally-accepted standard. To determine whether your device & IVD falls into the
The newly revised Medical Device Classification Catalog (hereinafter referred to as the “Classification Catalog”) released by China’s State Food and Drug Administration (CFDA) was officially released on August 31 this year but it won’t take into effect until August 1, 2018. The implementation of a new policy or regulation usually requires a period of transition so that relevant departments, units
The new “medical equipment classification directory” In recent years, the rapid development of China’s medical device industry, at present there are about 77,000 valid registration certificates of medical devices and more than 37,000 records of medical devices. With the continuous emergence of new technologies and new products, the current medical device classification system has been unable to fully meet the
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 not yet been listed in a “classification catalog” or medical devices that are waiting for classification notification by the CFDA, applicants should submit a classification application in CFDA classification system.
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 Class II IVD included on this list. In the U.S., the medical device/IVD approval process is mature and well-developed, and 80% of medical devices/IVD can find referred predicate products and
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 and changing regulatory environment. The “Management Standard for Technical Review and Consulting for Medical Devices,” (Management Standard) released in October 2016 has essentially closed the existing channel for pre-submission consultation
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 information system “, filling out the “classification application form” after registration, and uploading other application documents. Print the “classification application form” online and seal on the perforation of the form
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