July 3, 2018

Monthly CFDA News Roundup (June 2018)

Monthly CFDA News Roundup covers policies, government reports, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC ( […]
July 2, 2018

Faster and Lower-Cost Entry into China: 4th Batch of Clinical Exempted List Published

On June 11, CFDA published “4th Batch of Clinical Exempted Medical Devices and IVDs (Draft)” for feedback. 85 medical devices and 277 IVDs have been newly-exempted from clinical trial in […]
July 2, 2018

Siemens and Medtronic to be Inspected on Clinical Site

The GCP requirements on medical devices have intensified. On June 25, CFDA issued the first notification in 2018 for the upcoming clinical inspections for 9 medical devices and an IVD. […]
June 29, 2018

2018 3D Printing Medical Application Highlights (2)

Medical implants The 3D printed titanium mesh implant promotes bone regeneration In the medical field, the treatment of large bone defects or injuries remains a thorny field. But research teams […]
June 29, 2018

2018 3D Printing Medical Application Highlights (1)

Thanks to advantages such as high precision, solidity of finished products, and the ability to copy complex geometric models, 3D printing technology is increasingly used in more and more industries. […]