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2025 China NMPA Bluebook is here:
NMPA (CFDA) announced revisions of 27 medical device technical standards on June 6, 2019, involving multiple devices including Co-60 Teletherapy Unit, Infusion Sets with Precision Filters for Single Use and
NMPA (CFDA) issued the “Notice on Implementation of Electronic Submission System for Medical Device Registration” and “Technical Guideline on Registration Material Requirements for Electronic Submission System” on May 31. The
NMPA (CFDA) announced “2019 National Quality Inspection Plan for Medical Devices”. The Plan asks provincial NMPA offices and type testing centers to conduct quality inspections based on Industry Standards and
Pic: Getty Images On May 13, 2019, the Customs Tariff Commission of the State Council published the “Notice on Trial Implementation of Tariff Waiver Plan on Goods from USA and
Collaborate with AdvaMed, we present: China Adverse Event and PMS June 12, 2019 | 1:00 PM – 02:00 PM EDT Register Here Speaking with Varian VP Vy H. Tran, we will
NMPA issued “Notice on the Application of Certificate Authority (CA) certificate for Medical Device Registration Service Platform (eRPS)” on May 7, which introduced the Certificate Authority (CA) to all the
NMPA published draft version of IVD Clinical Trial Guideline for feedback on November 22, 2018. The draft guideline lists eight requirements for IVD clinical protocol. General information Including product information,
Varian announced on May 9 that it has signed a cooperation agreement with Shandong Cancer Hospital in China, on proton therapy clinical application and research. Varian has selected Shandong Cancer
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
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
Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com),
According to the Medical Device Classification Catalog, SaMD is a software that has one or more medical purposes to accomplish the intended use without medical device hardware, and operates on