China's NMPA Issues New Guidelines for In Vitro Diagnostic Reagent Classification
The National Medical Products Administration (NMPA) of China has released Notification No. 17 of 2024, introducing the "Catalogue of In Vitro Diagnostic Reagent Classification." This initiative is designed to streamline the classification process for in vitro diagnostic reagents as per the "Regulations on the Supervision and Management of Medical Devices" and other related guidelines. The Catalogue delineates the scope and structure of these reagents, excluding those used for legally mandated blood screening and those labeled with radioactive isotopes, and organizes them into a detailed system of 25 first-level and 1,852 second-level categories based on detection targets. It provides a pathway for the management of new products, allowing for direct Class III registration or category determination under the Classification Rules. The notification also specifies the management of various products including culture and cell culture media, and general reagents. Moreover, it announces the repeal of previous related notices, effective January 1, 2025, and highlights the dynamic adjustment of the Catalogue based on ongoing risk analysis and device evaluation. This systematic update aims to ensure regulatory compliance and facilitate the registration and filing processes for in vitro diagnostic reagents.
Read MoreInterpretation of the Guidelines for the Review of Usability Engineering in Medical Device Registration
The interpretation of "Guidelines for the Review of Usability Engineering in Medical Device Registration," published on March 27, 2024, are designed to enhance the usability requirements for Class II and Class III medical devices in China. These guidelines emphasize the critical role of human-machine interaction in medical device design, focusing on ensuring safety, effectiveness, and ease of use through comprehensive usability engineering. They specify processes for usability engineering lifecycle quality control, detail the verification and confirmation of user interfaces, and address the unique challenges associated with imported devices. Additionally, the guidelines discuss how usability engineering relates to clinical trials, the evaluation of existing user interfaces, and the specific considerations for devices used in combination. Application instructions for medical device registration under these guidelines include the submission of usability engineering research reports or use error evaluation reports, depending on the device's risk level. This initiative aims to align China's regulatory standards with international practices, thereby enhancing its global regulatory influence.
Read MoreChina's NMPA Announces 2024 Medical Device Industry Standard Revision Plan
The National Medical Products Administration (NMPA) has announced a plan to revise 98 medical device industry standards in 2024, aiming to enhance safety, efficacy, and quality in response to evolving healthcare needs in China.
Read MoreChina's NMPA Releases New Guidelines for Usability Engineering in Medical Device Registration
On March 19, 2024, the National Medical Products Administration's (NMPA) Center for Medical Device Evaluation in China released the "Guidelines for Usability Engineering in Medical Device Registration," aiming to standardize usability engineering practices for medical devices to ensure their safety and effectiveness through improved user interface design.
Read MoreChina's NMPA CMDE Releases Five New Registration Review Guidelines for Medical Devices
China's NMPA CMDE has introduced five new registration review guidelines for specific medical devices, including Monkeypox Virus Nucleic Acid Test Kits, Corneal Topography Devices, Laparoscopic Surgical Systems, and Medical Device Optical Radiation Safety, bringing the total number of effective guidelines to 613 by the end of 2023, covering 92.2% of China's medical device classification catalog.
Read MoreChina Sets New Benchmarks in Medical Device Industry with Ambitious 2023 Standardization Initiatives
In 2023, China significantly advanced its medical device industry by approving and publishing a wide range of national and industry standards, establishing key standardization technical organizations, and reinforcing its commitment to safety, innovation, and global competitiveness.
Read MoreGuidelines for the Performance Evaluation of Pathological Image AI Analysis Software: Ensuring Accuracy and Compliance in Medical Diagnostics
The "Key Points for the Performance Evaluation Review of Pathological Image AI Analysis Software" provides essential guidelines for the evaluation of AI software in pathology, covering data collection, algorithm performance, and safety standards to ensure the reliability and effectiveness of AI diagnostics tools.
Read MoreChina Announces the Release of 20 New Medical Device Industry Standards
On February 19, 2024, the National Medical Products Administration (NMPA) of China announced the release and implementation of 20 revised and new standards for medical devices, aimed at enhancing product quality, safety, and regulatory compliance across a broad spectrum of medical technologies.
Read MoreGroundbreaking Guidance Released by the NMPA on Real-World Study Design for Medical Devices
The "Guidance on Real-World Study Design and Statistical Analysis for Medical Device Registration Review" issued by the NMPA and CMDE on January 10, 2024, revolutionizes the use of real-world data in China's medical device clinical evaluations, enhancing device safety and efficacy assessments in real-life applications.
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