NMPA Released Five Guidelines for Medical Devices
On June 5, 2020, NMPA released five guidelines for medical devices 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/CL2138/378013.html
| Guideline Name | Link |
| Technical Review Guidelines of Tendon and Ligament Fixation System Registration | https://www.cmde.org.cn/CL0112/21041.html |
| Technical Review Guidelines of 3D Printing Acetabular Cup Product Registration | https://www.cmde.org.cn/CL0112/21042.html |
| Technical Review Guidelines of 3D Printing Vertebral Body Registration | https://www.cmde.org.cn/CL0112/21043.html |
| Technical Review Guidelines of Registration in Facial Implant for Plastic Surgery | https://www.cmde.org.cn/CL0112/21044.html |
| Technical Review Guidelines of Total Knee System Product Registration | https://www.cmde.org.cn/CL0112/21045.html |
