NMPA Released Five Guidelines for Medical Devices
On July 2, 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 links are listed in the table below. China Med Device suggest manufactures to follow the new requirements to do relevant registration.
Link: http://www.nmpa.gov.cn/WS04/CL2050/378426.html
http://www.nmpa.gov.cn/WS04/CL2138/378480.html
| No. | Guideline Name | Link |
| 1. | Guidelines on Nomenclature for Active Implantable Devices | http://www.nmpa.gov.cn/directory/web/WS04/images/uL28jEgINK908OzycxxvfQtc2o08PD+7PGwzD+9a4tbzUrdTyLmRvYw==.doc |
| 2. | Guidelines on Nomenclature for Dental Equipment | http://www.nmpa.gov.cn/directory/web/WS04/images/uL28jMgILax7uxsb30LXNqNPDwuzxsP8wvWuLW81K3U8i5kb2M=.doc |
| 3. | Guidelines on Nomenclature for Medical Imaging Devices | http://www.nmpa.gov.cn/directory/web/WS04/images/uL28jEgINK908OzycxxvfQtc2o08PD+7PGwzD+9a4tbzUrdTyLmRvYw==.doc |
| 4. | Technical Review Guidelines for In Vitro Synchronized Cardioversion Product Registration | https://www.cmde.org.cn/CL0112/21198.html |
| 5. | Technical Review Guidelines for Extracorporeal Pacing Product Registration | https://www.cmde.org.cn/CL0112/21199.html |
