NMPA: Mindray, MicroPort and Other 6 Products Plan to Enter the Innovation Channel
On March 1, CMDE announces 6 products to be entered into the innovation channel:
In accordance with the requirements of NMPA’s Special Review Procedures for Innovative Medical Devices (Announcement No. 83 of 2018 of NMPA), the Innovative Medical Device Review Office organized relevant experts to review the application for special review of innovative medical devices, and intends to agree to the following application project has entered the special review process and is now publicized.
|
Serial Number |
Product | Applicant |
| 1 | Full Automated Peripheral Blood Cell Morphology Analyzer | Shenzhen Mindray |
| 2 | Transcatheter Aortic Valve System | Peijia Medical |
| 3 | Anti-CD19-Chimeric Antigen Receptor T Cell Detection Kit (flow cytometry PE) | Grand Bay Bio |
| 4 | Prostate Lifting System | MicroPort |
| 5 | Bioresorbable Peripheral Vascular Drug Eluting Stent Systems | Beijing Advanced Medical Technologies, Ltd. Inc. (AMT) |
| 6 | Paclitaxel Drug Coated Peripheral Balloon Dilated Catheter |
BartyMedical |
Announcement period: March 1, 2022 to March 15, 2022
BradyKnows can provide manufacturers with all kinds of standardized consultation and standardized training services. Please do not hesitate to contact us at info@bradyknowsmedical.com, if you have any question in the gap between your products and NMPA’s standards.
