Blog

July 17, 2018

CFDA Q&A: Clinical Trial Quality Management for Medical Devices

Q: How to calculate the one-year validity period for the type testing report issued by the inspection institution? A: For the multi-center clinical trials, the one-year validity period is calculated […]
July 16, 2018

Two Invoice Policy Will Reshape China Distribution Landscape (2)

Two Invoice Policy in China Brings Great Opportunities for The Integration of Medical Device Industry At the end of January 2018, the “Two Invoice Policy” has been implemented in 24 […]
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 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. […]
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. […]
June 28, 2018

Abbott Deepens Knowledge in China Infectious Disease Market

Abbott is a globally diversified healthcare company with over $21 billions in sales and 94,000 employees in 150 countries. Its revenues are splits 58% in developed markets and 42% in […]