CFDA Updates

June 14, 2019

NMPA (CFDA) Publishes 27 Industry Standards in One Day: Time to Update Your Design Control

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 […]
June 7, 2019

NMPA: E-Submission to be effective on June 24, 2019

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 […]
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 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, […]