NMPA Released Seven Guidelines for Medical Devices
On May 9, 2020, NMPA released seven guidelines for medical device in order to strengthen the surveillance and guidance of the registration of medical device products and further improve the quality of registration review. All the new guidelines and their links are listed in the table below. Bradynuoen suggest manufactures to follow the new requirements to do relevant registration.
Link: http://www.nmpa.gov.cn/WS04/CL2138/377061.html
| Guideline Name | Link |
| Guidelines for Technical Review of Vertebroplasty Balloon Dilatation Catheter Registration | https://www.cmde.org.cn/CL0112/20877.html |
| Guidelines for Technical Review of Registration in Acrylic Bone Cement for Artificial Joint Replacement | https://www.cmde.org.cn/CL0112/20878.html |
| Guidelines for Technical Review of Registration in Intramedullary Nail Systems | https://www.cmde.org.cn/CL0112/20879.html |
| Guidelines for Technical Review of Registration in Petrolatum Gauze | https://www.cmde.org.cn/CL0112/20880.html |
| Guidelines for Technical Review of Registration in Hydrogel Dressing | https://www.cmde.org.cn/CL0112/20881.html |
| Guidelines for Technical Review of Registration in Puncture Aspiration Needle Applied in Assisted Reproduction | https://www.cmde.org.cn/CL0112/20882.html |
| Guidelines for Technical Review of Registration in Quality Control for Clinical Evaluation of Spinal Implants | https://www.cmde.org.cn/CL0112/20883.html |
