Blog

July 23, 2019

NMPA (CFDA): Three New Requirements Posed on E-Submission

NMPA (CFDA) issued “Notice on Requirements for Medical Device Electronic Submission” on July 10. It lists three requirements which are to be implemented on August 1, 2019. When registering imported […]
July 17, 2019

China Med Device interviewed by BioWorld on AI-Aided Software Guideline

NMPA published Technical Guideline on AI-Aided Devices on June 28, 2019. Grace Fu Palma, CEO of China Med Device, and Zhiyong Rao, Testing Director of China Med Device, were interviewed […]
July 10, 2019

NMPA (CFDA) News Roundup 201906

The Monthly NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recalls/AEs, and new approvals in medical devices and IVDs in China. It is edited by ChinaMed Device, LLC […]
July 8, 2019

How to Advertise Your Medical Device in China?

Q: What regulations are applicable for advertising medical devices in China? A: The current applicable regulations include: Methods of Medical Device Advertisement Reviewing (NMPA NO. 65, 2009) Advertising Law of […]
July 3, 2019

NMPA (CFDA) Final Guideline on AI-Aided Software: Propels China to the Leadership of AI Applications

NMPA (CFDA) issued the Technical Guideline on AI-Aided Software on June 28, 2019.  After the draft version issued on February 1, nearly five months of efforts have been made to classify the vital evaluation points […]
June 27, 2019

Suspension of Importation to China by CFDA after Overseas Inspection

In 2019, NMPA (CFDA) has announced 3 batches of Overseas Inspection Results. A total of 24 foreign manufacturers, including Medtronic, Becton Dickinson, Boston Scientific, B.Brown, Bausch & Lomb and Varian, […]
June 25, 2019

Clinical Trial and CFDA Inspection Success for Hemostatic Powder by ChinaMed Device, LLC

ChinaMed Device, LLC (CMD), a leader in helping medtech/IVD companies with RA, QA and CRO in China, has successfully helped a medical device company to get clinical trial and NMPA […]
June 21, 2019

2018 CFDA Medical Device Registration Report

NMPA (CFDA) published 2018 Medical Device Registration Report on May 31. ChinaMed Device compiled the data and made four charts to illustrate the current trend for imported devices in China. […]
June 19, 2019

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

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 […]