On May 27, China CMDE.NMPA releases 48 guidance documents. The list is as follows:
1. Guidelines for Registration Review of Electric Photography Flat Beds
2. Guidelines for registration review of medical gas alarm systems
3. Guidelines for registration review of air-oxygen mixer products
4. Guidelines for registration review of radiotherapy laser positioning equipment
5. Guidelines for registration review of in vivo electrodes for nerve and muscle stimulators
6. Guidelines for Registration Review of Rehabilitation Training Beds
7. Guidelines for registration review of electroencephalograph products
8. Guidelines for registration review of medical gynecological gel
9. Guidelines for Registration Review of Disposable Oxygen Mask Product
10. Guidelines for registration review of atomized mask products
11. Guidelines for registration review of bronchial occluders
12. Guidelines for registration review of medical catheter fixation devices
13. Guidelines for Registration Review of Respiratory mask
14. Guidelines for registration review of micromanipulated tubes for assisted reproduction
15. Guidelines for registration review of electrolyte analyzers
16. Guidelines for registration review of glucose detection reagents
17. Guidelines for registration review of reagents for the identification of Gram-negative bacilli
18. Guidelines for registration review of pyruvate determination reagents
19. α-amylase detection reagent registration review guidelines (download)
20.Guiding principles for registration review of α-hydroxybutyrate dehydrogenase assay reagents (download)
21. Guidelines for registration review of magnesium testing reagents (download)
22. Guidelines for registration review of semi-automatic chemiluminescent immunoassay analyzers (2024 revised version) (download)
23. Guiding Principles for Registration Review of Detection Reagents for Flow Cytometry (Category I and II) (2024 Revised Edition) (Download)
24. Guidelines for Registration and Review of Photographic X-ray Machines (2024 Revised Edition) (Download)
25. Guidelines for Registration and Review of Dental Integrated Treatment Machines (2024 Revised Edition) (Download)
26. Guiding Principles for Registration Review of Medical Nebulizers (2024 Revised Edition) (Download)
27. Hearing aid registration review guidelines (2024 revised edition) (Download)
28. Guidelines for Registration Review of Magnetic Therapy Products (2024 Revised Edition) (Download)
29. Creatine kinase detection reagent registration review guidelines (2024 revised version) (download)
30. Guiding Principles for Registration Review of Coagulation Analyzers (2024 Revised Edition) (Download)
31. Guiding Principles for Registration and Review of Cold Light Sources for Medical Endoscopes (2024 Revised Edition) (Download)
32. Guidelines for Registration and Review of Positive Pressure Ventilation Therapy Machines (2024 Revised Edition) (Download)
33. Guidelines for Registration Review of β2-Microglobulin Assay Reagents (2024 Revised Edition) (Download)
34. Guidelines for Registration Review of Thyroid Stimulating Hormone Determination Reagents (2024 Revised Edition) (Download)
35. Guiding Principles for Registration Review of Ischemia Modified Albumin Assay Kit (2024 Revised Edition) (Download)
36. Guidelines for Registration Review of Lactate Dehydrogenase Assay Kits (2024 Revised Edition)
37. Guidelines for Registration Review of Glycated Hemoglobin Determination Kit (Enzymatic Method) (2024 Revised Edition)
38. Guidelines for Registration Review of Sialic Acid Assay Kit (Enzymatic Method) (2024 Revised Edition)
39. Guidelines for Registration Review of C-Reactive Protein Assay Kits (2024 Revised Edition)
40. Guidelines for Registration Review of Peritoneal Dialysis Equipment (2024 Revised Edition)
41. Guidelines for registration review of urine analyzers (2024 revised edition)
42. Guidelines for Registration Review of Medical Image Storage and Transmission Software (PACS) (2024 Revised Edition)
43. Guidelines for registration review of vibrating percussion expectoration machines (2024 revised edition)
44. Guidelines for Registration Review of Large Pressure Steam Sterilizers (2024 Revised Edition)
45. Guidelines for Registration Review of Triglyceride Determination Reagents (2024 Revised Edition)
46. Guidelines for Registration Review of Alkaline Phosphatase Assay Reagents (2024 Revised Edition)
47. Guidelines for Registration Review of Urine Formed Component Analyzers (2024 Revised Edition)
48. Guidelines for registration review of hemodialysis water treatment equipment (2024 revised edition)