CFDA Updates

March 17, 2019

AdvaMed Webinar: How to Navigate Type Tsting in China

Collaborate with AdvaMed (click link HERE), we present: How to Navigate Type Testing in China Webinar March 20, 2019 | 10:30 – 11:30 am EST Register Here China FDA (NMPA) […]
March 14, 2019

Medtronic and Bausch & Lomb Cited in NMPA Overseas Inspection: Defects Revealed

NMPA (CFDA) published the latest batch of overseas inspection results on March 5. Seven overseas medical device and IVD manufacturers were cited:Medtronic, Bausch & Lomb, DiaSorin, AL.CHI.MI.A., GELITA MEDICAL, PERMEDICA, […]
March 11, 2019

ChinaMed Device is cited by BioWorld MedTech

On March 1st, 2019, Grace Palma, CEO of China Med Device, is interviewed by BioWorld MedTech about the revised registration guidelines for medical devices. With revised registration guidelines, China moves closer […]
March 5, 2019

Common Issues in NMPA Clinical Trial Audit (2016-2018)

NMPA (CFDA) clinical trial requirements have been significantly strengthened over the years. In 2016, 8 out of 20 clinical trials have been identified with issues in clinical trial audits. In […]
February 25, 2019

2019 Registration Guidelines Revision Plan Announced Today: Huge Impact on Registrations and Renewals

NMPA announced the “2019 Medical Device Registration Guidelines Revision Plan” today (February 25), in which 86 medical devices, IVDs and documentation methods are included. The Guidelines Revisions are aimed to […]