Grace PalmaRWD in China: Study Design and Statistical Analysis Guideline Propels Hainan to be World LeaderThe NMPA published the “Guideline on Medical Device Real World Study Design Statistical Analysis (Draft)” today, September 28, 2023, just…Oct 2, 2023Oct 2, 2023
Grace PalmaNMPA: Forty-five Standards Issued in One DayThe NMPA published 45 standards on September 7, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and…Oct 1, 2023Oct 1, 2023
Grace PalmaGuideline Issued for AI Infused MRIThe NMPA published the “Review Key Points for Artificial Intelligence Software for AI Magnetic Resonance Imaging Systems” on September 15…Sep 30, 2023Sep 30, 2023
Grace PalmaQ&A for Hong Kong New Medical Device Procurement Policy; Fifth Batch of GBA Urgent Use Plan…The Hong Kong Department of Health has implemented a new medical device procurement policy, effective from June 21, 2023. The policy…Sep 29, 2023Sep 29, 2023
Grace PalmaFour Data Management Guidelines Issued for Devices and IVDs, Propelling China to be the Leader of…The NMPA issued four data management guidelines on August 15, 2023. These documents are formulated to facilitate the information technology…Sep 19, 2023Sep 19, 2023
Grace PalmaAI Infused Software as a Medical Device (SaMD) for Ischemic Stroke Detection Approved in ChinaThe NMPA granted innovation approval to Ischemic stroke CT image assisted assessment software and released the review report in July 2023.Sep 18, 2023Sep 18, 2023
Grace PalmaNMPA Roundup August 2023Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in August 2023. These updates are…Sep 17, 2023Sep 17, 2023
Grace PalmaNMPA Published Benefit-risk Assessment GuidelineThe NMPA released the “Medical Device Benefit-risk Assessment Guideline (2023 revised version)” on July 18, 2023. Through the benefit-risk…Sep 16, 2023Sep 16, 2023
Grace PalmaNMPA Issued Eight Guidelines in AugustThe NMPA published eight new guidelines in August 2023, to direct manufacturers for local type testing, pre-clinical, clinical studies, and…Sep 7, 2023Sep 7, 2023
Grace PalmaSeventy-Six Standards of 9706 Series Listed by NMPAThe NMPA summarized 76 Medical Electrical Standards, GB 9706 Series, which is equivalent to IEC60601.Sep 6, 2023Sep 6, 2023
