Uncategorized

February 19, 2020

Coronavirus Spurs Emergency Device Approvals in China; Reveals Lessons for Manufactures to Speed Market Entry

While the Novel Coronavirus (COVID-19) has caused a tragic loss of life in China, the crisis demonstrates the flexibility of the country’s health agency. In just a couple of weeks, […]
December 16, 2019
Medical Device Classification & Registration in China

Medical Device Classification & Registration in China – 4 Things You Must Know

You may find it complicated and confusing when trying to navigate through China’s medical device classification, registration and clinical trials process. In addition, to make the matters worse, specific regulatory […]
December 13, 2019

Real World Data Clinical Guideline Published Today; China Med Device Pioneered in the Program

Pic: China Premier Li Keqiang visited the Hainan International Medical Tourism Pilot Zone on Mar 25, 2019. NMPA issued the “Guideline on Real World Data (RWD) Used in Medical Device […]
December 11, 2019

16 Devices Recalled in November; One Class I Recall

NMPA announced Recall Notices for 16 imported medical devices in November. Class I recall (the most serious): Edwards Lifesciences: Aortic perfusion cannula Class II and Class III recall: GE: Patient […]
December 5, 2019
Medical Device GMP in China

GMP for Medical Devices in China – A Quick Guide

Striving to meet good manufacturing practices (GMP) for medical devices in China can be challenging. The following article will provide answers to the most common questions about GMP for medical […]