May

May 31, 2019

2019 National Quality Inspection Plan Just Released: Pay Attention to Your Device Standards

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 […]
May 30, 2019

Trade War is Escalating, While China Released Tariff Waiver Plan

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 […]
May 24, 2019

New Webinar! China Adverse Event and PMS

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 […]
May 22, 2019

New E-filing Requirement Posed for Legal Agent in China

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 […]
May 17, 2019

NMPA Requirements for IVD Clinical Trial Protocol Design

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, […]
May 14, 2019

Varian to Collaborate with Shandong Cancer Hospital on Proton Therapy Application

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 […]
May 10, 2019

CFDA Taking Actions for AI Device Registration Applications

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 […]
May 7, 2019

Monthly NMPA News Roundup (April 2019)

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), […]
May 3, 2019

What SaMD in China has clinical exemption?

According to 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 a […]