May 27, 2020
China periodic risk evaluation report

Periodic Risk Evaluation Report: China’s NMPA Further Specifies PMS Requirements

May 21, 2020

NMPA Approves the First Medical Device Through Real-World Data Program

Allergan’s Glaucoma treatment system became the first medical device obtained NMPA Approval through Real-World Data (RWD) program. The program, which has been piloted in Hainan since June 2019, was joined […]
May 11, 2020

NMPA News Roundup (April 2020)

Here’s April’s NMPA news affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a colleague and opt-in here. For […]
May 8, 2020

NMPA to Down-Classify Certain Cancer Biomarker Reagents

NMPA will reclassify 29 cancer biomarker-related reagents from class III to class II with an announcement on April 24th, 2020. The impacted reagents include but not limited to the following: […]
May 7, 2020

China Enhancing Quality Inspection for Exported COVID-19 Medical Devices

Premier Li Keqiang of China, center, speaking at the Jinyintan hospital in Wuhan/ Reuters The Chinese government is moving to enhance quality inspection and export supervision for domestic COVID-19 related […]
May 5, 2020

NMPA Guideline for MAH: Eight Major Requirements on Adverse Event Monitoring

On April 10, the NMPA issued the “Guideline for Medical Device Market Authorization Holders (MAHs) to Conduct Adverse Event Monitoring”. Based on Decree 1 Medical Device Adverse Event Reporting and […]