China Regulatory Update – NMPA Launches New Standard Projects for 2026
- Date
- March 13, 2026
- Category
Other Regulations
- Description
In February 2026, the NMPA issued the 2026 national plan for medical device industry standard development and revision. A total of 80 industry standard development and revision projects and 2 foreign‑language edition projects have been finalized and made public.
These projects cover a broad range of product areas, including:
- Respiratory and emergency care (e.g., emergency ventilator reliability)
- Hemodialysis systems (e.g., water treatment equipment and dialysate quality)
- Medical imaging (MRI spectroscopy parameters, SPECT/CT and PET/CT performance, digital X‑ray, CT time‑resolution evaluation)
- Implantable and orthopedic devices, cardiovascular and dental devices
- AI‑ and robotics‑related technologies
- Medical device packaging, sterility, and materials
Source: 国家药监局综合司关于印发2026年医疗器械行业标准制修订计划项目的通知
Earlier, in January 2026, the NMPA also approved two new industry standard projects for brain–computer interface (BCI) medical devices:
- Paradigm Design and Application Specification — Motor Function Reconstruction
- Invasive Devices — Reliability Verification Methods
Source: 国家药监局综合司关于《采用脑机接口技术的医疗器械范式设计与应用规范运动功能重建》等2项医疗器械行业标准立项的通知
As these standards may influence future regulatory expectations, we kindly encourage you to review the 2026 standards plan and check whether any of the listed projects relate to your products. If so, it could be beneficial to actively join the public consultation process and share your technical feedback.