November 26, 2019

NMPA New Guideline on How to Address “Submission Deficiency” in China

NMPA issued the “Medical Device Submission Document Requirements during the Supplement Phase” (Draft) on November 11, 2019. Feedback needs to be summited by November 30, 2019. The document specifies the […]
November 22, 2019

NMPA Focuses on 3D Printed Device: Five Guidelines Issued in Three Months

NMPA published five guidelines for 3D printed devices from August to October 2019: Registration Guideline on 3D Printed Implantable Bone, Joint and Oral Hard Tissue Registration Guideline on 3D Printed […]
November 13, 2019

NMPA (CFDA) News Roundup 201910

The NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. It is edited by China Med Device, LLC […]
November 11, 2019

AdvaMed Webinar: Latest Developments in Clinical Pathways for NMPA (CFDA) Submission

Time: Tuesday, November 12, 2019 | 11:00 am – 12:00 pm ET Presented by China Med Device, LLC Register Here This webinar will cover different clinical pathways and how to […]
November 6, 2019
NMPA Regulations

China Medical Device Regulations – An Overview

China National Medical Products Administration regulates medical devices and pharmaceutical products across China. The NMPA was also known as China Food and Drug Administration in the past. For medical device […]
November 3, 2019

In One Day, 28 Class II Device Guidelines Released by NMPA

NMPA issued 28 draft guidelines on October 18 for feedback. The guidelines cover one class III device, 27 class II devices and IVDs (cardiovascular, gastroenterological, urological, dental, gynecological and pediatric […]