Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
Foreign Medical Device Makers Can Use Overseas Labs for China Registration Self-Testing, NMPA Final Guideline Says
NMPA published the document “Guideline on Self-Testing for Medical Device Registration” on September 16, 20205. The document provides a comprehensive framework for how domestic and overseas applicants conduct product self-testing when applying for registration in China. Noticeably, it allows overseas firms to leverage their in-house testing resources—such as labs already certified under ISO/IEC 17025 or accredited by regulatory agencies like the FDA or European Notified Bodies—to conduct regulatory testing for China submissions. For our comprehensive analysis, click HERE
Medical Device Online Sales QMS Takes Effect October 1, 2025
The NMPA published the “Quality Management Regulation on Online Sales of Medical Devices” on April 28, 2025, which takes effect on October 1, 2025. This regulation establishes a comprehensive framework to ensure the safety, traceability, and quality compliance of medical devices sold through online channels. Given that any devices, even Class III, can be sold online, it is vital for domestic and overseas manufacturers alike to follow the new rules. For the detailed information, click HERE
Guidelines & Standards
NMPA’s New Standard Brings Devices Usability Engineering in Line with Global Practices
NMPA issued the draft standard “Medical Devices – Part 1: Application of Usability Engineering to Medical Devices” on August 28, 2025 for feedback. The document defines a process that integrates human factors into design, connects usability to risk management, and demands clear evidence of compliance through documentation and evaluation. Click HERE for more information
NMPA Issues Standard for Closed-Loop BCI Neurostimulators, Setting Stage for Next-Gen Intelligent Implants
NMPA released the industry standard of “Test method for sensing and feedback performance of the interactive neurostimulator for medical equipment using brain-computer interface technology”, which takes effect on October 1, 2025. This document provides a rigorous and multi-faceted framework for qualifying the next generation of intelligent neurostimulators. By standardizing test methods for perception hardware, stimulation output, closed-loop response time, and the core intelligence algorithms, the document aims to foster the development of safe, effective, and reliable BCI-based closed-loop therapies. Click HERE for more information
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent you for product life cycle without your need to create a local entity in China. Our RA services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.