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2026 China NMPA Bluebook is here:
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
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
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
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
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 implants The 3D printed titanium mesh implant promotes bone regeneration In the medical field, the treatment of large bone defects or injuries remains a
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
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
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,
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
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
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