July 12, 2018

Two Invoice Policy Will Reshape China Distribution Landscape (1)

“Two Invoice Policy” means that the pharmaceutical production enterprise issues one invoice to the circulation enterprise, and the circulation enterprise issues one invoice to the hospital. It effectively prevent the […]
July 11, 2018

CFDA: Two Ophthalmology Clinical Guidelines Issued

CFDA published Clinical Guideline on Rigid Gas Permeable (RGP) Contact Lens and Clinical Guideline on Soft Contact Lens on July 5th, to facilitate the applicants with clinical trial process on […]
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 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 […]