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2026 China NMPA Bluebook is here:
Picture: Grace Palma, CEO of China Med Device, LLC in RWD workshop in Hainan The NMPA published the “Guideline on Medical Device Real World Study
The NMPA published 45 standards on September 7, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. It includes 6
The NMPA published 45 standards on September 7, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. It includes 6
The NMPA published the “Review Key Points for Artificial Intelligence Software for AI Magnetic Resonance Imaging Systems” on September 15, 2023. The guideline applies to
The NMPA published the “Review Key Points for Artificial Intelligence Software for AI Magnetic Resonance Imaging Systems” on September 15, 2023. The guideline applies to
The Hong Kong Department of Health has implemented a new medical device procurement policy, effective from June 21, 2023. The policy prioritizes Medical Device Administrative
The Hong Kong Department of Health has implemented a new medical device procurement policy, effective from June 21, 2023. The policy prioritizes Medical Device Administrative
The NMPA issued four data management guidelines on August 15, 2023. These documents are formulated to facilitate the information technology infrastructure for medical device registration
The NMPA issued four data management guidelines on August 15, 2023. These documents are formulated to facilitate the information technology infrastructure for medical device registration
The NMPA granted innovation approval to Ischemic stroke CT image assisted assessment software and released the review report in July 2023. This software is designed
The NMPA granted innovation approval to Ischemic stroke CT image assisted assessment software and released the review report in July 2023. This software is designed
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in August 2023. These updates are presented by China