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NMPA Roundup December 2023


NMPA Roundup December 2023

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


Six AI Guidance Issued for Medical Device Software in 2023, Propelling China to be World Leader

NMPA affiliated Artificial Intelligence Medical Device Innovation Cooperation Platform summarized six AI related guidelines released in 2023. These documents are “based on the characteristics of AI medical devices, clarifying the technical review requirements, including general and key product requirements, and building a standard system to enhance China’s AI industry development and international influence in the space”, the platform says. For the list of guidelines please click HERE

Guidelines & Standards

Clinical Trial Inspection Key Points Ask Feedback

NMPA issued the “Key Points and Principles for Medical Device Clinical Trial Inspections (Draft) on November 28, 2023. Feedback needs to be submitted by December 31, 2023.

It stipulates on Conditions and Compliance, Protection of Subject Rights, Protocol, Implementation, Traceability and Reporting, and Devices Management of Clinical Trial. Among them, the Implementation is divided into three parts: Subject Screening and Enrollment, Execution of Clinical Trial Protocol, and Processing and Reporting of Safety Information. For our comprehensive review please click HERE

Four Draft Clinical Guidelines Issued in One Day

NMPA issued four draft clinical guidelines on December 11, 2023. Feedback needs to be submitted by January 2, 2024. It contains clinical regulations on intracranial thrombectomy stent, facial injection filler material, extracorporeal membrane oxygenation system, and spring coil system. Click HERE to learn more

Manufacturing & PMS

Three Imported Devices Found Defects in On-site Inspection

NMPA conducted on-site quality inspection on eleven types of medical devices and released the result on December 18, 2023. Eighteen manufacturers are found incompliance, including three overseas companies: Abbott Diagnostics, GALLINI and Nidek Medical. For the root causes please click HERE

Fast-Track Channel

Two Imported Devices Gain Innovation Approval in December

NMPA granted innovation approvals to seven devices in December 2023, for indications ranging from cardiovascular, orthopedic, immunology and urology. Among them are two imported devices: Varian’s proton therapy system, and BioNTech Diagnostics’ human breast cancer molecular subtyping detection kit. For more information please visit HERE

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