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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 […]
April 29, 2019

New Classification Procedures for Combination Device Take Effect on June 1, 2019

NMPA (CFDA) issued Notice on Classification Procedures for Combination Device on April 17th. The new procedures will be effective on June 1, 2019: A specialized department, NMPA Standardization Management Center […]
April 24, 2019

Do You Need Animal Study for Your Device? NMPA Gives 12 Devices as Examples

NMPA (CFDA) issued “Medical Device Animal Study Technical Review Guideline Part I: Decision Principles” on April 19. The guideline lists 12 devices as examples to discuss if animal study is […]
April 22, 2019

Common Errors in Writing NMPA IVD Clinical Protocol

Clinical trial protocol is a vital component in IVD clinical design and, in China, the details of the protocol never fail to be questioned by NMPA (CFDA) reviewers.  ChinaMed Device, […]
April 19, 2019

NMPA: E-Filling to be Effective in Two Months

“Electronic Regulated Product Submission (eRPS) will come into force by the end of June, 2019”, Zhong Lu, deputy head of NMPA Center for Medical Device Evaluation (CMDE), announced at the […]