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…
It has been recently learned that according to the notice of the NMPA, the “Cerebrovascular Interventional Surgery Auxiliary Operating System” of Endo Medical, the holding subsidiary of Beijing Vas Medical, has been approved by NMPA, and the registration certificate number is National Instrument Registration Permit 20233010311. more…
From March 1 to March 4, 2023, the 13th China International Medical Device Regulatory Forum (CIMDR) was held in Fuzhou, Fujian Province, China. CIMDR is one of the most important regulatory conferences in China on medical device, and NMPA, CMDE and related experts attended this forum to release the latest regulatory updates. The major insights from the 13th CIMDR are listed as below. more…
