NMPA Released Eight Guidelines for Medical Devices
On June 17, 2020, NMPA released eight 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 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/CL2138/378183.html
| No. | Guideline Name |
| 1. | Technical Review Guidelines for Heat and Moisture Exchanger Registration |
| 2. | Technical Review Guidelines for Low Frequency Electrotherapy Apparatus Registration |
| 3. | Technical Review Guidelines for Electric Pneumatic Hemostatic Instrument Registration |
| 4. | Technical Review Guidelines for Pulmonary Function Tests Registration |
| 5. | Technical Review Guidelines for Medical CO2 Incubator Registration |
| 6. | Technical Review Guidelines for Shockwave Therapy Device Registration |
| 7. | Technical Review Guidelines for Hot Packs Registration |
| 8. | Technical Review Guidelines for Audiometer Registration |
