On September 8, 2020, CMDE announced its preparation of Technical Review Guideline on the Medical Device Cybersecurity (draft). This Guideline is the second version draft on the cybersecurity issues of the medical devices. more…
On September 3, 2020, CMDE announced its preparation of Technical Guideline on the Registration of Predicate Clinical Evaluation of Ultrasonic Soft Tissue Cutting Hemostatic Systems (draft). more…
In late August, 2020, NMPA released an announcement of the withdraw of 10 medical device registration certificates. Three of them are IVD products from Guangzhou Fenghua Biological Engineering Co.,Ltd The rest of them are medical devices from TXF Medical, Guangzhou Fenghua Biological Engineering Co.,Ltd and ResMed Ptv Ltd respectively. more…
On August 26, 2020, CMDE issued a notification that the “Pure titanium powder was formed for oral prosthesis by laser selective melting” of Xi’An Bright Laser Technologies Co.,Ltd is proposed to obtain the priority pathway approval, because this product is listed in the national key research and development plan. more…
