In 2025, China’s National Medical Products Administration (NMPA) continued to advance regulatory approvals for surgical robotic systems at a steady, normalized pace.

Throughout the year, we tracked all new surgical robot approvals granted by the NMPA, covering both newly registered systems and newly approved indications. This annual summary includes only approvals issued in 2025, and excludes navigation systems as well as registration certificate changes.

*NMPA approval process plays a role comparable to FDA clearance in the US or CE marking in Europe, but follows its own review pathways and timelines.

Key observations from the data

Approvals remain highly concentrated by category

Orthopedic surgical robots accounted for the largest share of NMPA approvals in 2025, far exceeding other surgical specialties and continuing to form the backbone of annual approvals.

Percutaneous, laparoscopic, and natural-orifice robotic systems constituted a second tier, with approval volumes remaining in the single digits. Vascular intervention and neurosurgical robotic systems saw very limited NMPA approvals, indicating that these segments are still at an early stage of regulatory progression in China.

Overall, the approval gap across different technical pathways continued to widen, reflecting divergent levels of product maturity and regulatory readiness under the NMPA framework.

No short-term approval surge under the NMPA in 2025

From a timing perspective, NMPA approvals were distributed relatively evenly across all four quarters of the year, with no evidence of a policy-driven or batch-style approval window.

Monthly approval counts showed moderate fluctuations but remained within a stable range. This pattern suggests that in 2025, surgical robot approvals under the NMPA were primarily driven by individual product registration progress, rather than by centralized policy acceleration.

A stabilizing regulatory trend rather than rapid expansion

Taken together, three signals stand out from the 2025 NMPA approval data:

• Approval volumes continued to advance, but without a clear acceleration inflection point

• Category stratification became more pronounced, with orthopedic robotics maintaining a structural lead

• The NMPA approval rhythm increasingly reflects a normalized, case-by-case review process

For readers interested in sales performance, please refer to the 2025 China Laparoscopic Surgical Robot Tender Report and the 2025 China Orthopedic Surgical Robot Market Sales Report, which cover sales data in China for global surgical robotic systems.

MedChina, January 28, 2026