The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration (NMPA) has announced the publication of updated guidelines for the registration and review of Class III ultrasound imaging devices on October 14, 2024. This revision, released as Announcement No. 29 of 2024, aims to further standardize the management of these medical devices in China.
The document, titled "Guidelines for Registration Review of Class III Ultrasound Imaging Devices (2023 Revised Edition)," provides comprehensive guidance for manufacturers and reviewers involved in the registration process of advanced ultrasound equipment.
Key aspects of the guidelines include:
1. Scope: The guidelines apply to various Class III ultrasound imaging devices, including ultrasound pulse echo imaging equipment, ultrasound echo Doppler imaging equipment, ultrasound probes, and ultrasound electronic endoscopes.
2. Registration requirements: Detailed information on product classification, technical requirements, risk management, and clinical evaluation.
3. Safety and performance: Emphasis on compliance with relevant national and industry standards, including acoustic output safety requirements.
4. Software and artificial intelligence: Specific requirements for software validation and AI functionality in ultrasound devices.
5. Biological evaluation: Guidelines for assessing the biocompatibility of materials used in ultrasound probes and other patient-contacting components.
6. Clinical applications: Clarification on the intended use and clinical applications for different types of ultrasound probes and imaging modes.
7. Product labeling and instructions: Requirements for comprehensive and clear product labeling and user manuals.
The CMDE states that these updated guidelines reflect the current regulatory framework, standards, and technological advancements in the field of medical ultrasound imaging. The document is expected to serve as a valuable resource for both registration applicants and technical reviewers, ensuring the safety and effectiveness of ultrasound imaging devices in the Chinese market.
Manufacturers and stakeholders in the medical device industry are advised to carefully review and implement these guidelines in their registration processes for Class III ultrasound imaging equipment in China.
MEDTECH NEWS
China's NMPA Releases Updated Guidelines for Class III Ultrasound Imaging Devices
15 10 2024China's NMPA has released updated guidelines for Class III ultrasound imaging devices. Announced on October 14, 2024, the revised document aims to standardize management of these medical devices. It covers registration requirements, safety standards, software validation, and clinical applications. The guidelines reflect current regulations and technological advancements, serving as a resource for manufacturers and reviewers.