On April 11, 2024, CMDE released the 2024 medical device registration review guideline preparation plan. Please refer to the following list:
| Plan for the formulation of guidelines for registration review of Class III medical devices | |
| No. | Guiding principle name |
| 1 | Guidelines for Magnetic Resonance Safety Evaluation of Medical Devices |
| 2 | Guidelines for Registration Review of High-Pressure Injection Equipment for Contrast Media |
| 3 | Guidelines for registration review of X-ray blood irradiation equipment |
| 4 | Guidelines for Registration Review of Portable Electric Infusion Pump |
| 5 | Guidelines for registration review of animal testing of extracorporeal membrane oxygenation equipment |
| 6 | Guidelines for Registration Review of Radiation Therapy Planning Software |
| 7 | Guidelines for Registration Review of Beam Scanning Measurement Systems |
| 8 | Guidelines for Registration Review of Laparoscopic Surgery System Part 3: Systems and Software |
| 9 | Guidelines for Registration Review of Fluorescence Diagnostic Functions of Active Optical Devices |
| 10 | Guidelines for Registration Review of Carbon Dioxide Laser Therapy Machines |
| 11 | Guidelines for registration review of tumor radiofrequency ablation equipment |
| 12 | Guidelines for registration review of electrocoagulation and cutting endoscopes |
| 13 | Guidelines for registration review of capsule endoscopy systems |
| 14 | Guidelines for registration review of urinary system laser treatment machines |
| 15 | Guidelines for Registration Review of Laparoscopic Surgical Systems Part 4: Risk Management |
| 16 | Guidelines for Registration Review of Aortic Stent Graft |
| 17 | Guidelines for product registration review of acellular matrix soft tissue wound repair materials |
| 18 | Guidelines for Registration Review of Transcatheter Valve Clamp System |
| 19 | Guidelines for Registration Review of Memory Alloy Rib Plate |
| 20 | Guidelines for registration review of metal bone needles |
| 21 | Guidelines for registration review of skull repair mesh systems |
| 22 | Guidelines for Registration Review of Sternal Strapping/Grasping Fixation Systems |
| 23 | Guidelines for Registration and Review of Filling Materials for Oral Hard Tissue |
| 24 | Guidelines for Registration Review of Absorbable Synthetic Polymer Bone Internal Fixation Implants |
| 25 | Guidelines for Registration Review of Type I Collagen Cartilage Repair Gel Products |
| 26 | Guidelines for Registration Review of Oral Restorative Film |
| 27 | Guidelines for Registration Review of Antimicrobial Coating Performance Evaluation of Orthopedic Implants |
| 28 | Guidelines for registration review of single-use anesthesia puncture needles |
| 29 | Guidelines for registration review of alginate fiber dressings |
| 30 | Guidelines for registration review of platelet-rich plasma preparation devices |
| 31 | Guidance for registration review of prefilled catheter irrigators |
| 32 | Guidelines for Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials Part 5: Research on Alternative In Vitro Testing Methods |
| 33 | Guidelines for registration review of human KRAS mutation gene detection reagents |
| 34 | Guidelines for registration review of enzymatic detection reagents traceability |
| 35 | Guidelines for Registration Review of Glucose-6-phosphate Dehydrogenase Detection Reagent |
| 36 | Guidelines for registration review of human T lymphocytic leukemia virus antibody detection reagents |
| 37 | Guidelines for registration review of human leukocyte antigen (HLA) gene DNA typing detection reagents |
| 38 | Guidelines for registration review of Helicobacter pylori resistance gene detection reagents |
| 39 | Guidelines for registration review of Dengue virus NS1 antigen detection reagent |
| 40 | Guidelines for registration review of Inferior vena cava filter clinical trial |
| 41 | Guidelines for Substantial Equivalence review of clinical evaluation — dental restorative materials for implant use |
| 42 | Guidelines for Substantial Equivalence review of clinical evaluation — orthopedic surgery navigation and positioning systems |
| 43 | Guidelines for Registration Review of Clinical Trials — Coronary Modification Balloons |
| 44 | Guidelines for registration review of clinical trials — left atrial appendage occlusion device system |
| Revision Plan for Guidelines for Registration Review of Class III Medical Devices | |
| No. | Guidelines name |
| 45 | Guidelines for Registration Review of Implantable Pacemaker (2024 revised edition) |
| 46 | Guidelines for Registration Review of Implantable Cardiac Lead Products (2024 Revised Edition) |
| 47 | Guidelines for Registration Review of Sodium Hyaluronate Facial Injectable Filling Materials (2024 Revised Edition) |
| 48 | Guidelines for Registration Review of Dental Resin Filling Material Products (2024 Revised Edition) |
| 49 | Guidelines for Conditional Approval of Medical Devices for Marketing (2024 Revised Edition) |
| Plan for the formulation of guiding principles for registration review of Class II medical devices | |
| No. | Guidelines name |
| 50 | Guidelines for Registration Review of Electronic Stethoscope |
| 51 | Guidelines for Registration Review of Home Non-Invasive Ventilators (Non-Life Support) |
| 52 | Guidelines for Registration Review of Medical Center Attraction System |
| 53 | Guidelines for Registration Review of Traction bed |
| 54 | Guidelines for Registration Review of Vision Training Device |
| 55 | Guidelines for Registration Review of Gastroscopy Lubricant Product |
| 56 | Guidelines for registration review of scissors for endoscopic surgery |
| 57 | Guidelines for Registration Review of Gastrointestinal Contrast Imaging Agent Products |
| 58 | Guidelines for Registration Review of Orthopedic device |
| 59 | Guidelines for Registration Review of Disposable Rhinoscope Products |
| 60 | Guidelines for Registration Review of Ventilation Nasal Patch |
| 61 | Guidelines for Registration Review of Disposable Endoscopic Biopsy Bags |
| 62 | Guidelines for registration review of single-use sterile urethral dilators |
| 63 | Guidelines for registration review of medical radiation protective sprays |
| 64 | Guidelines for Registration Review of Trace Element Analyzers |
| 65 | Guidelines for Registration Review of Streptococcus Identification Reagents |
| 66 | Guidelines for Registration Review of Lipoprotein A detection reagent |
| 67 | Guidelines for Registration Review of Hemorheology Analyzer |
| 68 | Guidelines for Registration Review of γ-Glutamyl transferase detection reagent |
| 69 | Guidelines for registration review of anti-thyroglobulin (TG) antibody detection reagents |
| Revision Plan for Guidelines for Registration Review of Class II Medical Devices | |
| No. | Guidelines name |
| 70 | Guidelines for Registration Review of Electric Traction Devices (2024 Revised Edition) |
| 71 | Guidelines for registration review of ultraviolet therapeutic equipment (2024 revised edition) |
| 72 | Guidelines for Registration Review of Biological Microscopy (2024 Revised Edition) |
| 73 | Guidelines for registration review of infrared therapy equipment (2024 revised edition) |
| 74 | Guidelines for Registration Review of Medium Frequency Electrotherapy Products (2024 Revised Edition) |
| 75 | Guidelines for Registration Review of Single-use ECG electrode (2024 revised version) |
| 76 | Guidelines for Registration Review of Electrocardiographs (2024 Revised Edition) |
| 77 | Guidelines for Registration Review of Patient Monitoring Products (Class II) (2024 Revised Edition) |
| 78 | Guidelines for Registration Review of Medical Suction Devices (2024 Revised Edition) |
| 79 | Guidelines for registration review of microplate readers (2024 revised edition) |
| 80 | Guidelines for registration review of laparoscopic surgical instruments (2024 revised edition) |
| 81 | Guidelines for Registration Review of Rigid Endoscopes (Category 2) (2024 Revised Edition) |
| 82 | Guidelines for registration review of perimetry (2024 revised edition) |
| 83 | Guidelines for Registration Review of Visible Spectrum Therapeutic Device (2024 Revised Edition) |
| 84 | Guidelines for registration review of slit lamp microscopy (2024 revised edition) |
| 85 | Guidelines for registration review of ambulatory blood pressure measuring devices (2024 revised edition) |
| 86 | Guidelines for Registration Review of Holter Electrocardiogram Systems (2024 Revised Edition) |
| 87 | Guidelines for registration review of surgical shadowless lamps (2024 revised edition) |
| 88 | Guidelines for Registration Review of Infrared Breast Scanner (2024 Revised Edition) |
| 89 | Guidelines for Registration Review of Electric Wheelchairs (2024 Revised Edition) |
| 90 | Guidelines for Registration Review of Ear-Cavity Medical Infrared Thermometers (2024 Revised Edition) |
| 91 | Guidelines for registration review of small steam sterilizers (2024 revised edition) |
| 92 | Guidelines for Registration Review of Infusion Pump (2024 Revised Edition) |
| 93 | Guidelines for Registration Review of Central monitoring software (2024 revised edition) |
| 94 | Guidelines for Registration Review of Semiconductor Laser Treatment Machines (Category II) (2024 Revised Edition) |
| 95 | Guidelines for Registration Review of Ultrasound Doppler Fetal Monitor (2024 Revised Edition) |
| 96 | Guidelines for Registration Review of Ultrasound Physiotherapy Equipment (2024 Revised Edition) |
| 97 | Guidelines for Registration Review of Ultrasound Doppler Fetal Heart Rate Monitor (2024 Revised Edition) |
| 98 | Guidelines for Registration Review of Ultrasonic Dental Cleaning Equipment (2024 Revised Edition) |
| 99 | Guidelines for Registration Review of Balloon Inflatable Devices for Intravascular Balloon Dilatation Catheters ( 2024 Revised Edition) |
| 100 | Guidelines for Registration Review of Hysterosalpingography Balloon Catheter (2024 Revised Edition) |
| 101 | Guidelines for registration review of luteinizing hormone detection reagents (colloidal gold immunochromatography) (2024 revised version) |
| 102 | Guidelines for Registration Review of Cardiac troponin I/myoglobin/creatine kinase isoenzyme MB detection reagent (colloidal gold immunochromatography) (2024 revised edition) |
| 103 | Guidelines for Registration Review of Electrolyte Potassium, Sodium, Chloride and Calcium Determination Reagents (2024 Revised Edition) |
| 104 | Guidelines for Registration Review of Cystatin C determination reagent (latex transmission immunoturbidimetry) (2024 revised edition) |
| 105 | Guidelines for Registration Review of Optometry (2024 Revised Edition) |
| 106 | Guidelines for Registration Review of Flexible Fiber Endoscopes (Category 2) (2024 Revised Edition) |
| 107 | Guidelines for Registration Review of Medical Ozone Gynecological Therapeutic Devices (2024 Revised Edition) |
| 108 | Guidelines for Registration Review of Ultrasound Bone Densitometer (2024 Revised Edition) |
| 109 | Guidelines for registration review of high-density lipoprotein cholesterol measurement reagents (2024 revised edition) |