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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 post Q&A for Hong Kong New Medical Device Procurement Policy; Fifth Batch of GBA Urgent Use Plan Announced appeared first on China Med Device.

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 post Four Data Management Guidelines Issued for Devices and IVDs, Propelling China to be the Leader of Medical Information Technology appeared first on China Med Device.

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 […] The post AI Infused Software as a Medical Device (SaMD) for Ischemic Stroke Detection Approved in China appeared first on China Med Device.

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 post NMPA Roundup August 2023 appeared first on China Med Device.

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 post NMPA Published Benefit-risk Assessment Guideline appeared first on China Med Device.

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 post NMPA Issued Eight Guidelines in August appeared first on China Med Device.

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 post Seventy-Six Standards of 9706 Series Listed by NMPA appeared first on China Med Device.

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 post NMPA Down-Classified Five Class III Medical Devices appeared first on China Med Device.

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: […] The post Four Foreign Manufacturers Registered Raw Materials in Master File in August appeared first on China Med Device.

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 […] The post China GMP Support: Our Successful Case Study appeared first on China Med Device.