September

September 25, 2019

NMPA – First Group of UDI Devices Released: 64 Devices as First Trial

CFDA issued the First Group of Unique Device Identification Devices (Draft) for feedback on September 17, and specified the medical devices going into UDI implementation. Devices Impacted In early July, […]
September 17, 2019

NMPA Guideline on Raw Material Change: 11 Devices as Example

NMPA (CFDA) published the “Guideline on Raw Material Change Evaluation of Non-active Device (Draft)” on June 27. Discussing design control, change control, Basic Safety and Effectiveness List, evaluation pathways, implications […]
September 13, 2019

AdvaMed VIP Social: you’re invited!

Please join us on Tuesday evening during the AdvaMed MedTech annual conference for an extraordinary networking social. AdvaMed Networking Meet top China government officials and hospital CEOs, AdvaMed leaders and […]
September 10, 2019

NMPA News Roundup 201908

NMPA News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. Keep yourself updated with NMPA News Roundup, click HERE to […]
September 6, 2019

Grace Palma, CEO of China Med Device, interviewed by BioWorld on Tariffed Medical Device

After the U.S. announced the tariff plan of $300 billion Chinese exports, China released the newest tariff list on $75 billion of U.S. exported goods on Aug 23. Amid the […]