Beijing, China – 09 Sep 2026 – The Center for Medical Device Evaluation (CMDE) of China’s National Medical Products Administration (NMPA) has published the proposed results of its Special Review of Innovative Medical Devices (Announcement No. 15 of 2026), indicating that eight device applications are proposed for entry into the special review program under NMPA Announcement No. 83 of 2018. The public notice period runs from 9 September to 23 September 2026, during which any organization or individual may submit written objections to the CMDE.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA / Center for Medical Device Evaluation (CMDE) |
| Announcement | Special Review Results for Innovative Medical Devices, No. 15 of 2026 |
| Legal Basis | Special Review Procedure for Innovative Medical Devices (NMPA Announcement No. 83 of 2018) |
| Products Proposed | 8 device applications |
| Notice Period | 9–23 September 2026 |
| Objections | Written submissions to gcdivision@cmde.org.cn |
| Next Steps | Final review conclusion determines actual entry; applicants must still complete R&D and submit registration applications |
Proposed Products & Applicants
| # | Product | Applicant |
|---|---|---|
| 1 | Intravesical endoscopic surgery system | Guangzhou Qiaojie Medical Technology Co., Ltd. |
| 2 | Implantable wireless brain‑computer interface (BCI) system | Beijing Zhiran Medical Technology Co., Ltd. |
| 3 | Liquid embolic agent | MicroPort NeuroTech (Shanghai) Co., Ltd. |
| 4 | Single‑use magnetic‑localization, pressure‑monitoring radiofrequency pulsed ablation catheter | St. Jude Medical (an Abbott company) |
| 5 | Temperature‑sensitive liquid embolic agent | Guangdong Guangna Anliao Technology Co., Ltd. |
| 6 | Deep‑brain macro‑micro electrode | Beijing Huake Hengsheng Medical Technology Co., Ltd. |
| 7 | Single‑branch aortic arch stent‑graft system | Lifetech Scientific (Shenzhen) Co., Ltd. (HKEX: 1302) |
| 8 | Human homologous recombination deficiency (HRD) detection reagent kit – Joint Probe Anchored Sequencing (JPAS) method | Purui Jizhun Biopharmaceutical (Suzhou) Co., Ltd. |
Portfolio Profile
- Frontier Neurotechnology: Two neuro‑applications — an implantable wireless BCI system and a deep‑brain macro‑micro electrode — highlight China’s accelerating push into neural interfaces and neuromodulation hardware.
- Interventional Cardiology & Neurovascular: The list pairs St. Jude Medical’s next‑generation ablation catheter with two liquid embolic agents (including a temperature‑sensitive formulation) and Lifetech Scientific’s single‑branch aortic arch stent‑graft, addressing complex structural and neurovascular indications.
- Precision Diagnostics: The HRD detection kit using the JPAS method targets companion‑diagnostic testing for homologous recombination repair deficiency — a key biomarker for guiding PARP inhibitor therapy in oncology.
- Procedural Robotics: Guangzhou Qiaojie’s intravesical endoscopic surgery system extends the cohort into minimally invasive urologic surgery platforms.
Program Context
- Special Review Mechanism: Established under the 2018 procedure, the program grants innovative devices early engagement, dedicated reviewers, and scientific review — with standards not lowered and procedures not reduced — to accelerate market access.
- Important Caveats: The CMDE stressed that this public notice is not itself the basis for entry into the special review program; entry depends on the final review conclusion. Moreover, entry does not constitute recognition that a product has demonstrated registrable safety and effectiveness — applicants must still complete development and registration per applicable requirements.
Market Impact & Outlook
- Innovation Signal: The eighth‑month cadence of special‑review lists continues to channel domestic and multinational R&D toward high‑value, first‑of‑kind devices in China.
- Multinational Participation: St. Jude Medical (Abbott) appearing alongside domestic sponsors underscores the program’s role as a priority pathway for global innovators seeking early China market entry.
- Competitive Dynamics: Dual entries in the liquid embolic category suggest an emerging head‑to‑head race in neurovascular embolization materials, while the BCI listing positions China among the regulators formally advancing implantable neural interface devices.
- Diagnostic‑Therapeutic Convergence: The HRD/JPAS kit reflects tighter integration between companion diagnostics and oncology drug development, a pairing increasingly favored under China’s precision‑medicine agenda.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the CMDE’s proposed special‑review outcomes, the public‑objection process, and subsequent registration expectations for the listed devices. Actual results may differ; entry into the special review program remains subject to the final review conclusion and does not imply approval of safety or effectiveness.-China Health Reform Pulse
Policy Source: https://www.cmde.org.cn/xwdt/zxyw/20260909151140162.html