Human factors design for medical devices in China has draft guidelines revised and issued by the Center Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) on October 10, 2023.
The objective of these guidelines is to provide clear directives to registration applicants regarding the human factors design process for medical devices. Simultaneously, they aim to standardize the requirements for the technical evaluation of medical devices’ human factors design.
These guidelines apply to the registration and application of human factors design for class II and class III medical devices and do not encompass in vitro diagnostic reagents. Registration applicants may refer to these guidelines for all medical device human factors design work.
- Human Factors Design and Usability: At the heart of these guidelines lies the concept of human factors design. It involves leveraging knowledge from various domains, including anatomy, physiology, psychology, behavior, and culture, to develop medical devices that enhance usability. Human factors engineering knowledge encompasses a wide range of areas, including but not limited to the human body, perception, cognition, and action.
- Basic Principles: The guidelines emphasize several fundamental principles, including human factors design positioning, risk-based approach, and full lifecycle management. These principles are instrumental in tailoring the human factors design process to the specific risk level of the medical device. By considering industry development and risk classification, applicants can determine the appropriate level of lifecycle quality control. Higher-risk medical devices, for instance, would require comprehensive human factors design throughout their lifecycle, while lower-risk devices can align with risk management processes.
- High-Risk Medical Devices: Notably, the guidelines identify high-risk medical devices, which are currently limited to certain Class III devices. To streamline the evaluation process, the “Second Draft” also introduces the “Catalog of High-Risk Medical Device Products (Trial).” For new high-risk medical devices, a summary usability test approach is recommended for human factors design confirmation. In contrast, mature products can opt for an equivalent medical device comparative evaluation method.
- Equivalent Medical Devices: The guidelines define equivalent medical devices as those with fundamental similarities to the registered medical device in terms of intended use, applicable populations, user groups, user characteristics, usage environments, key tasks, human-machine interaction, and user training. Comparative evaluations for equivalent medical devices can refer to the clinical evaluation methods used for similar device categories. In cases where no equivalent medical devices exist or the comparative evaluation lacks sufficient evidence, a summary usability test is recommended for conclusive assessment.
Read the original article on draft guidelines for medical device human factors design registration and feedback form.
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