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 […]
April 29, 2020

Reduced Time and Cost: China Plans to Adopt Latest Edition of IEC 60601-1

China mandated electrical medical device manufacturers to comply with its national mandatory standard GB 9706.1-2007, equivalent to IEC 60601-1 Edition 2, since 2008. Even though overseas manufacturers adopted IEC 60601-1 […]
April 27, 2020

China Med Device to Hold RAPS Webinar on China & U.S Regulatory Response to COVID-19

China NMPA and U.S FDA have been preparing regulatory establishments for the novel Coronavirus (COVID-19) since late January. China Med Device, LLC, with its partner Musculoskeletal Clinical Regulatory Advisers (MCRA), […]
April 24, 2020

NMPA: Two Devices Granted Innovation Status

On April 23, 2020 NMPA CMDE (Center of Medical Device Evaluation) granted two innovative medical device status: Microtech Medical: Continuous Glucose Monitoring System Edwards Lifesciences: Transcatheter Valve Repair Clip NMPA […]