Recently, in order to strengthen the management of medical device clinical trial institutions (hereinafter referred to as institutions) and standardize their supervision and inspection work, in accordance with relevant more…
For manufacturers operating medical devices in China, NMPA has issued the deadline for submitting the 2022 Annual Quality System Self-Inspection Report to China’s provincial level NMPA on March 31st, 2023. more…
According to the announcement, the ninth batch of excellent domestic medical equipment product catalog selection will be launched recently, the ninth batch of selection of 13 categories, including: Ultrasonic endoscope system, mobile special medical magnetic resonance imaging equipment for infants, artificial intelligence assisted imaging diagnosis (fracture), minimally invasive breast incision equipment, near-infrared brain oxygen saturation monitor, non-invasive hemodynamics monitoring system, dynamic brain electrical impedance imaging system, high flow respiratory more…
Recently, according to the Medical Device Registration and Archival Management Measures, In Vitro Diagnostic Reagents Registration and Archival Management Measures Medical Device Clinical Trial Institutions Conditions and Archival Management Measures , Medical Device Clinical Trial Quality Management Standards and other relevant provisions, The Comprehensive Department of the NMPA publicly solicits opinions on the Supervision and Inspection Points and Judgment Principles of Medical Device Clinical Trial Institutions (Draft for Soliciting Opinions). more…
On March 14, 2023, the NMPA issued the 45th batch of information on medical device approvals, including 9 new registration approvals with 5 new imported medical devices and 4 new domestic medical devices. Details are listed as below. more…
On March 14, 2023, the NMPA issued the 45th batch of information on medical device approvals, including 9 new registration approvals with 5 new imported medical devices and 4 new domestic medical devices. Details are listed as below. more…
On 24 March 2023, the NMPA issued four regulations to accompany the Anti-Monopoly Law, namely the Regulations on the Suppression of Abuse of Administrative Power to Exclude and Restrict Competition, the Regulations on the Prohibition of Monopoly Agreements, the Regulations on the Prohibition of Abuse of a Dominant Market Position and the Regulations on the Review of Concentration of Operators, which will come into effect on 15 April 2023. more…
On March 21,2023, in order to further promote the high-quality development of the medical device industry, Zhejiang Provincial MPA formulated and issued the Implementation Opinions on Optimizing the Review and approval of Medical device Registration (later called Implementation more…
