Blogs

July 9, 2018

CFDA’s Opinions on Device Registration (June 2018)

Monthly Opinions on Device Registration covers preclinical, clinical and registration issues in medical device and IVD in China. It is published by CFDA and edited by China Med Device, LLC […]
July 3, 2018

CFDA:Imported Medical Devices Only Account For 15% of Innovation Approvals

CFDA granted innovation approval status for 28 medical devices in the first half of the year, covering the indication of cardiovascular (10), oncology (7), orthopedic (5), immunology (4) and urology […]
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 (www.ChinaMedDevice.com) […]
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. […]