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2025 China NMPA Bluebook is here:
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 mandatory standards and 39 recommended
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 MRI systems adopting AI technology,
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 Control System (MDACS)-listed medical devices,
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 and filing, encompassing both domestic
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 to aid healthcare professionals in
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 Med Device, LLC, your partner
The NMPA released the “Medical Device Benefit-risk Assessment Guideline (2023 revised version)” on July 18, 2023. Through the benefit-risk judgment table in which standard review consideration factors are listed, the
The NMPA published eight new guidelines in August 2023, to direct manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Full List For an English copy of any
The NMPA summarized 76 Medical Electrical Standards, GB 9706 Series, which is equivalent to IEC60601. The standards have been effective since May 1, 2023. For active product manufacturers with existing
The NMPA reclassified certain neurosurgical, cardiac surgery, orthopedic, and hemodialysis, radiological equipment and devices and modified intended use for some with an announcement on August 21, 2023. Read the list
The NMPA renewed the list of raw material master files on August 14, 2023. Four foreign manufacturers became master file owners for their raw materials or key components in August:
Here is our summary of our successful study with China GMP’s support. Guide a US manufacturer with 5 global sites to comply with China GMP Objectives Key Activities Recommended Areas