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NMPA Roundup September 2023


Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in September 2023. These updates are presented by China Med Device, LLC, your partner in Chinese market access.


RWD in China: Study Design and Statistical Analysis Guideline Propels Hainan to be World Leader

NMPA published the “Guideline on Medical Device Real-world Study Design and Statistical Analysis (Draft)” on September 28, 2023. It asks feedback by October 16, 2023. The proposed guideline will facilitate overseas manufacturers to further explore the Hainan Real-world Data pilot program.

The document describes different types of real-world research, outlines considerations for designing real-world research protocols, and emphasizes the importance of Quality Control. Click HERE for our comprehensive review

Q&A for Hong Kong New Medical Device Procurement Policy; Fifth Batch of GBA Urgent Use Plan Announced

The Hong Kong Department of Health has implemented a new procurement policy that prioritizes Medical Device Administrative Control System (MDACS)-listed medical devices. Manufacturers seeking to supply DH with medical devices are encouraged to list their products under MDACS.

China Med Device has summarized customers’ questions raised on the new Hong Kong policy.

Also, three drugs and five devices as the fifth batch were enrolled to pioneer the clinical use in Greater Bay Area in September 7, 2023. For the Q&A and the fifth batch plan, please click HERE

Guidelines & Standards

Guideline Issued for AI Infused MRI

NMPA published the “Review Key Points for Artificial Intelligence Software for Magnetic Resonance Imaging Systems” on September 15, 2023.

The guideline applies to MRI systems adopting AI technology, which is a Class III device according to “Medical Device Classification Catalog”. It mainly describes the functions and outlines the main review areas of AI infused MRI. For our comprehensive article, please click HERE

Four Data Management Guidelines Issued for Devices and IVDs

The NMPA issued four data management guidelines. These documents are formulated to facilitate the information technology infrastructure for medical device registration and filing, encompassing both domestic and imported medical devices falling under Class I, Class II, and Class III:

They establish standards for the identification of data elements, including their Chinese names, short names, definitions, data types, representation formats, allowable values, units of measurement, versions, and sources. These standards are applicable to the identification, exchange, and sharing of information related to medical devices and IVD products.

Also, they define the code domains for data elements used in the regulation of medical device and IVD registrations. These code domains are essential for representing, exchanging, identifying, and processing information related to medical devices and IVDs. For more information click HERE

Innovation Approvals

AI Infused Software as a Medical Device (SaMD) for Ischemic Stroke Detection Approved

The NMPA granted innovation approval to Ischemic stroke CT image assisted assessment software.

This software is designed to aid healthcare professionals in evaluating and categorizing abnormal CT scans of the brain. Employing AI algorithms to analyze CT image data and generate Alberta Stroke Program Early CT Score (ASPECTS), it quantitatively assesses the suspected acute large artery occlusion ischemic stroke patients within onset of 6 hours. Click HERE for the review report released by NMPA

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