Policies
NMPA Enables Early Regulatory Feedback on Innovative Medical Device Clinical Trial Protocols
The NMPA issued the “Pre-Review of Clinical Trial Protocols for Innovative Medical Devices” on March 13, 2026. This initiative allows innovative devices applicants to request a pre-review of their clinical trial protocols through the established communication channel for major technical issues. The feedback provided during this pre-review serves as a crucial reference for the subsequent technical evaluation process.
For the pre-review process and the application requirements, please click HERE
NMPA: All Class II Devices, IVDs Subject to UDI Starting June 1, 2027, with Exemptions
The NMPA, together with National Health Commission and National Healthcare Security Administration, issued the “Advancing UDI Implementation for Subsequent Device Categories” and “UDI Implementation under Specific Circumstances” on March 13, 2026. These two policies expand UDI coverage, refine technical requirements, and introduce targeted exemptions, marking a significant step toward full lifecycle traceability of medical devices in China.
For our comprehensive analysis, please click HERE
Guidelines & Standards
China NMPA Biological Evaluation Requirements Under ISO 10993: Framework, Expectations, and Global Alignment
The National Institutes for Food and Drug Control of NMPA released the draft GB/T 16886.1-2025, “Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process” on August 21, 2025 for feedback.
As this draft represents the Chinese adoption of ISO/FDIS 10993-1:2025, it becomes increasingly important to understand how biological evaluation is structured in practice—particularly the roles of the Biological Evaluation Plan (BEP) and the Biological Evaluation Report (BER), which form the foundation of regulatory submissions in both China and the U.S.
For the clarification of BEP vs. BER, and NMPA-aligned BEP strategy with example of blood-contacting devices, click HERE
Fast-track Approvals
Milestone Approvals of Thermal Vapor Therapy Systems for BPH in China: Boston Scientific’s Rezūm and Domestic Innovation Pave the Way for Accelerated Market Access Through Real-World Evidence
The NMPA approved Shanghai Lixiao’s thermal vapor therapy equipment and the single-use prostate thermal vapor therapy device on February 28, 2026. Previously, Boston Scientific’s Rezūm Water Vapor Therapy equipment and its disposable prostate treatment accessory were granted approvals in March 2022, which only took four months from submitting the registration application to getting NMPA nod, through Hainan Real-World Data program. For the details of the two approvals and the review reports on the Boston Scientific’s products, click HERE