Blogs

June 19, 2019

NMPA (CFDA) Newsletter (May 2019)

The NMPA (CFDA) Newsletter covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), a […]
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 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 […]