Today (December 15, 2025), the National Medical Products Administration (NMPA) released significant signals for medical device approvals and made multiple approvals on the same day.Implantable Deep Brain Stimulation SystemAndProton Therapy SystemTwo High-ValueMedicalDevice Launch and AnnouncementFiling Information for Imported Class I Medical Device Products in November 2025`, injecting new momentum into the clinical application of medical devices and the development of industry technology.`
1. Implantable Deep Brain Neurostimulation System Approved for Marketing
◆ Manufacturer: SceneRay Co., Ltd.
◆ Registration Certificate Number:
① G20253122578: Implantable Deep Brain Stimulation Electrode Lead
②China Medical Device Registration No. 20253122579: Implantable Deep Brain Stimulation Extension Lead
③ G20253122580: Implantable Deep Brain Neurostimulator
*The above three parts are used in combination to form an implantable deep brain stimulation system for relapse prevention and adjunctive treatment in patients with refractory moderate to severe opioid addiction.
2. Proton Therapy System Approved for Marketing
◆ Manufacturer: Varian Medical Systems Particle Therapy Co., Ltd.
◆ Registration Certificate No.: China Medical Device Registration No. 20253050582
Proton therapy system is a type of radiationTherapeutic Equipment, composed of an accelerator subsystem and a treatment subsystem, used for treating systemic solid malignant tumors and certain benign diseases.
3. November 2025 Import Class I Medical Device Product Filing Information
A total of updates this time154Medical Device Filing Information, Including 68 Changes, 52 Valid, and 34 Invalid Statuses:
◆68 Changes
◆52 Effective
◆34 Invalid
