NMPA Releases Medical Device Instruction Manual Non-Approval Notices – August 13, 2026

On August 13, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration published the latest delivery information for medical device instruction manual non-approval notices.According to the announcement, a total of 3 medical device labeling applications have not been approved, covering products across radiotherapy equipment, laser therapeutic devices, and surgical robotic systems.

Details are as follows:

1. Medical Electron Linear Accelerator (Acceptance No.: QSG2601714) — Applicant: Zhiwei Precision (Shenyang) Medical Technology Co., Ltd. This product is a critical piece of equipment in the field of radiation oncology.

2. Erbium-Doped Fiber Laser Therapeutic Apparatus (Acceptance No.: QSG2601826) — Applicant: Jilin Province Ke Ying Laser Co., Ltd. This device is primarily used in medical aesthetic and therapeutic laser applications.

3. Thoracolaparoscopic Surgical Robotic System (Acceptance No.: QSG2601848) — Applicant: Shanghai MicroPort MedBot (Group) Co., Ltd. As a representative product in the surgical robotics sector, its labeling review progress has drawn significant industry attention.

Important Reminder: Since June 1, 2024, applicants can log in to the NMPA Government Service Portal (under "My Applications") to view electronic versions of the documents and print them out following the provided instructions.

This announcement reflects the regulator's continued rigorous oversight of medical device labeling reviews—labeling documents serve as the core guidance for the safe and effective use of medical devices, and their standardization and scientific validity are directly tied to clinical risk management. The non-approvals span multiple types of high-value medical devices, signaling that manufacturers should further strengthen compliance and scientific rigor in key areas such as indication statements, risk warnings, and technical specifications.