Blog

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 […]
June 27, 2018
Illustration of a laptop computer showing Grace Fu Palma speaking during a presentation for a webinar

Grace Palma, CEO of China Med Device, is interviewed by RAPS on China Medical Device Amendment

On June 25, China State Council released a draft amendment to overhaul the medical device regulations. On June 27, Grace Palma, CEO of China Med Device, is interviewed by Zachary Brennan, […]
June 26, 2018

Historical Medical Device Changes from NMPA (CFDA) Announced Today

The last time the NMPA (CFDA) “Medical Device Supervision and Management Regulations” were completely overhauled was in 2014 with a supplemental update in 2017. Today (June 25th, 2018) the new […]
June 25, 2018

CFDA Cracking Down on Labeling—36% Defects Have Labelling Issues

On June 22, CFDA published Quality Notice #47 and identified 64 defects for 9 types of medical devices: nerve and muscle stimulator, ultrasonic atomizer, disposable vaginal dilator, insulin pimp, oxygen […]
June 23, 2018

Weekly CFDA News Roundup (June 11th to June 18th) 

Weekly CFDA News Roundup covers government reports, policies, 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) […]