The General Administration has issued three successive circulars, pointing to the guiding principles for the technical review of the registration of class 3 medical devices

Yesterday evening, the State Food and Drug Administration issued three circulars on the guiding principles of registration technology review of six medical devices, including PACS, ALP test kit and albumin test kit The details are as follows: 1、 Circular of the General Administration of the people's Republic of China on the issuance of the guiding principles for the technical review of the registration of six medical devices, including PACS (No 27, 2016) In order to strengthen the supervision and guidance of the registration of medical devices and further improve the quality of registration and examination, the State Food and drug administration has organized and formulated six technical examination guidance for registration of medical devices, including PACS, positive pressure ventilation therapy machine, large steam sterilizer, peritoneal dialysis machine, medical endoscope cold light source, vibration percussion sputum exhauster, etc Principles (see Annex) are hereby issued Notice is hereby given Appendix: 1 Guiding principles for technical review of registration of PACS 2 Guiding principles for technical review of registration of positive pressure ventilation therapy machine 3 Guiding principles for technical review of registration of large steam sterilizer 4 Guiding principles for technical review of registration of peritoneal dialysis machine 5 Guiding principles for technical review of registration of cold light source of medical endoscope 6 Guiding principles for technical review of registration of vibration percussion sputum extractor 2、 Circular of the General Administration on the issuance of guiding principles for technical review of registration of six medical devices (2016 Revision) such as alkaline phosphatase test kit (2016 No 28) In order to strengthen the supervision and guidance of the registration of medical devices and further improve the quality of registration and examination, the State Food and drug administration has organized the revision of alkaline phosphatase test kit, human chorionic gonadotropin test kit (colloidal gold immunochromatography), C-reactive protein test kit, fecal occult blood (FOB) test kit (colloidal gold immunochromatography) Guidelines for the technical review of registration of six medical devices, including the ischemia modified albumin test kit and creatine kinase test kit, are hereby issued Notice is hereby given Annex: 1 Guiding principles for registration technical review of alkaline phosphatase test kit (revised in 2016) 2 Guiding principles for registration technical review of human chorionic gonadotropin test kit (colloidal gold immunochromatography) (revised in 2016) 3 Guiding principles for registration technical review of C-reactive protein test kit (revised in 2016) 4 Guidelines for technical review of registration of fecal occult blood (FOB) test kit (colloidal gold immunochromatography) (revised in 2016) 5 Guidelines for technical review of registration of ischemic modified albumin test kit (revised in 2016) 6 Guidelines for technical review of registration of creatine kinase test kit (revised in 2016) 3、 Circular of the General Administration of the people's Republic of China on the issuance of guiding principles for technical review of registration of seven medical devices such as albumin determination kits (2016 No 29) In order to strengthen the supervision and guidance of the registration of medical devices and further improve the quality of registration and examination, the State Food and drug administration has organized and formulated albumin test kit, glycosylated hemoglobin test kit (enzyme method), lactate dehydrogenase test kit, thyrotropin test kit, triglyceride test kit and sialic acid test kit（ Guidelines for the technical review of registration of 7 medical devices, including enzyme method and β 2-microglobulin detection kit, are hereby issued Notice is hereby given Appendix: 1 Guiding principles for technical review of albumin test kit registration 2 Guiding principles for technical review of glycosylated hemoglobin test kit registration 3 Guiding principles for technical review of lactate dehydrogenase test kit registration 4 Guiding principles for technical review of thyrotropin test kit registration 5 Guiding principles for technical review of triglyceride test kit registration 6 Guidelines for technical review of sialic acid test kit (enzyme method) registration 7 Guidelines for technical review of β 2-microglobulin test kit (latex enhanced immunoturbidimetry)