Beijing, May 7, 2025 – The National Medical Products Administration (NMPA) Center for Medical Device Evaluation has officially released the “Guidelines for Registration Review of Mobile Medical Devices (2025 Revision)”, aimed at further regulating and guiding the management of mobile medical devices in China.
Modernizing Regulation for Mobile Health
This newly revised guideline serves to instruct applicants on preparing registration submissions for mobile medical devices, while specifying the technical requirements and risk management standards for these products. The document reflects the latest technological advancements and regulatory developments, ensuring that the oversight of mobile healthcare keeps pace with innovation.
Coverage and Key Principles
Applicable to all Class II and Class III medical devices—including in vitro diagnostic devices—using mobile computing technology, the guideline covers hand-held, wearable, and hybrid devices used for various medical purposes. It clarifies definitions for mobile medical equipment, stand-alone mobile software, and mobile medical accessories, distinguishing them from conventional and transferable medical devices.
The principles of the guideline emphasize:
- Assessment of both conventional device and mobile technology risks, such as battery life, screen limitations, data security, and environmental adaptability.
- Requirements for different device types, including performance standards for displays, user environment adaptability (including home use), and network security capabilities.
- The importance of full lifecycle quality control, from development through post-market monitoring.
Technical Considerations and Documentation
Applicants are now required to submit specialized research reports on the mobile computing platforms used, demonstrating rigorous risk management, suitability for clinical scenarios, and compliance with cybersecurity and human factors engineering standards. Clinical evaluation requirements reflect those for both traditional and digital healthcare systems, ensuring patient safety and product efficacy.
Alignment with International Standards
The guideline references major Chinese and international standards and incorporates concepts from digital health, medical device software, AI in healthcare, cybersecurity, and usability engineering. It complements existing NMPA regulatory guidance and is consistent with global regulatory trends.
Official Publication and Implementation
The revised guideline was developed by the NMPA's Center for Medical Device Evaluation and officially released on April 29, 2025. The full text is available as an annex on the NMPA website.
About NMPA’s Center for Medical Device Evaluation
The Center for Medical Device Evaluation is a technical arm of the NMPA, responsible for the scientific review and evaluation of medical devices, ensuring product quality, safety, and effectiveness for the Chinese public.