NMPA Released Six Guidelines for Medical Devices
On July 9, 2020, NMPA released Six 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 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/CL2138/378635.html
| No. | Guideline Name | Link |
| 1. | Technical Review Guidelines for the Registration of Disposable Breast Localization Wires | http://www.nmpa.gov.cn/directory/web/WS04/images/ufq80tKpxre84La9udzA7b7WMjAyMMTqtdo0OLrFzai45ri9vP4xLmRvYw==.doc |
| 2. | Technical Review Guidelines for Dura Substitution Registration | http://www.nmpa.gov.cn/directory/web/WS04/images/ufq80tKpxre84La9udzA7b7WMjAyMMTqtdo0OLrFzai45ri9vP4yLmRvYw==.doc |
| 3. | Technical Review Guidelines for the Registration of Equivalence Model of Customized Personalized Bone Implant | http://www.nmpa.gov.cn/directory/web/WS04/images/ufq80tKpxre84La9udzA7b7WMjAyMMTqtdo0OLrFzai45ri9vP4zLmRvYw==.doc |
| 4. | Technical Review Guidelines for Finite Element Analysis Data of Orthopedic Metal Implants | http://www.nmpa.gov.cn/directory/web/WS04/images/ufq80tKpxre84La9udzA7b7WMjAyMMTqtdo0OLrFzai45ri9vP40LmRvYw==.doc |
| 5. | Guidelines for Clinical Trials of Hernia Mesh | http://www.nmpa.gov.cn/directory/web/WS04/images/ufq80tKpxre84La9udzA7b7WMjAyMMTqtdo0OLrFzai45ri9vP41LmRvYw==.doc |
| 6. | Guidelines for Animal Experimental Study on Bioabsorbable Coronary Drug-eluting Stents | http://www.nmpa.gov.cn/directory/web/WS04/images/ufq80tKpxre84La9udzA7b7WMjAyMMTqtdo0OLrFzai45ri9vP42LmRvYw==.doc |
