Center for Medical Device Evaluation .NMPA| Summary of Guiding Principles Issued by China in 2021
In 2021, the Center organized and formulated 64 guiding principles for the registration and review of medical devices, which have been issued and implemented by the NMPA.
| Serial
Number |
Name of Guiding Principle | Official Document Number |
| 1 | Guidelines for Technical Review of Clinical Evaluation of the Same Type of X-ray Computed Tomography Equipment | Notice No. 2, 2021, NMPA |
| 2 | Guidelines for Review of Clinical Evaluation Techniques for Imaging Ultrasound Diagnostic Equipment of the Same Type | Notice No. 2, 2021, NMPA |
| 3 | Guidelines for Technical Review of Registration of Mycoplasma Pneumoniae IgM / IgG Antibody Detection Reagents | Notice No. 4, 2021, NMPA |
| 4 | Guidelines forTechnical Review of Registration of Genetic Deafness Related Gene Mutation Detection Reagents | Notice No. 4, 2021, NMPA |
| 5 | Guidelines for Technical Review of Cryptococcus Capsular Polysaccharide Antigen Detection Reagent Registration | Notice No. 4, 2021, NMPA |
| 6 | Guiding Principles for Technical Review of Clinical Evaluation of the Same Variety of Medical Magnetic Resonance Imaging System | Notice No.12, 2021, NMPA |
| 7 | Guidelines for Technical Review of the Registration of Group B Streptococcus Nucleic Acid Testing Reagents | Notice No.24, 2021, NMPA |
| 8 | Guidelines for Updating the Instruction Manual and Technical Review of Tumor Companion Diagnostic Reagents Based on Similar Therapeutic Drugs | Notice No.24, 2021, NMPA |
| 9 | Guiding Principles for Technical Review of Registration of Rotavirus Antigen Detection Reagents | Notice No.24, 2021, NMPA |
| 10 | Guidelines for Technical Review of Registration of Human Parvovirus B19 IgM / IgG Antibody Detection Reagents | Notice No.24, 2021, NMPA |
| 11 | Guidelines for Technical Review of Registration of Real-time Fluorescence PCR Analyzer | Notice No.24, 2021, NMPA |
| 12 | Guiding Principles for Technical Review of Citric Acid Dsinfectant Registration | Notice No.24, 2021, NMPA |
| 13 | Guidelines for Technical Review of Dental Glass Ionomer Cement Registration | Notice No.24, 2021, NMPA |
| 14 | Guidelines for Technical Review of Registration of Disposable Sterile Closure Clips | Notice No.30, 2021, NMPA |
| 15 | Guidelines for Technical Review of Registration of Disposable Injection Pen and Matching Needle | Notice No.30, 2021, NMPA |
| 16 | Guiding Principles for Technical Review of Breast X-ray System registration | Notice No.42 2021, NMPA |
| 17 | Guiding Principles for Technical Review of Vision Screening Instrument Registration | Notice No.42 2021, NMPA |
| 18 | Guiding Principles for Safety and Effectiveness Evaluation of Medical Devices Using Nano Materials Part I: System Framework | Notice No.65 2021, NMPA |
| 19 | Guiding Principles for Technical Review of Clinical Evaluation of Intravascular Catheter Comparison with the Same Variety | Notice No.68 2021, NMPA |
| 20 | Technical Guidelines for Clinical Trials of in Vitro Diagnostic Reagents (revised in 2021) | Notice No.72 2021, NMPA |
| 21 | Technical Guidelines for Deciding whether to Carry out Clinical Trials of Medical Devices | Notice No.73 2021, NMPA |
| 22 | Technical Guidelines for Comparison Description of Products Listed in the Catalogue of Medical Devices Exempted from Clinical Evaluation | Notice No.72 2021, NMPA |
| 23 | Technical Guidelines for Equivalence Demonstration of Clinical Evaluation of Medical Devices | Notice No.72 2021, NMPA |
| 24 | Technical Guidelines for Clinical Evaluation of Medical Devices (revised in 2021) | Notice No.72 2021, NMPA |
| 25 | Technical Guidelines for Clinical Evaluation Report of Medical Device Registration Application | Notice No.72 2021, NMPA |
| 26 | Technical Guidelines for Clinical Evaluation of in Vitro Diagnostic Reagents Exempted from Clinical Trials | Notice No.72 2021, NMPA |
| 27 | Guiding principles for registration and review of animal experimental research on medical devices Part I: decision making principles (revised in 2021) | Notice No.75 2021, NMPA |
| 28 | Guiding Principles for Registration and Review of Animal Experimental Research on Medical Devices Part II: Experimental Design, Implementation and Quality Assurance | Notice No.75 2021, NMPA |
| 29 | Guidelines for Registration Review of Data Submission Requirements for Clinical Trials of in Vitro Diagnostic Reagents | Notice No.91 2021, NMPA |
| 30 | Guidelines for Registration Review of Data Submission Requirements for Clinical Trials of Medical Devices | Notice No.91 2021, NMPA |
| 31 | Neurological and Cardiovascular Surgical Instruments – Guidelines for Registration Review of Knives, Scissors and Needles | Notice No.92 2021, NMPA |
| 32 | Guiding Principles for Technical Review of Clinical Evaluation of the Same Variety of Ultrasonic Soft Tissue Cutting Hemostasis System | Notice No.93 2021, NMPA |
| 33 | Guiding Principles for Registration and Review of the Same Variety of Oral Implant Surgery Navigation and Positioning System for Clinical Evaluation | Notice No.93 2021, NMPA |
| 34 | Guidelines for Registration and Review of Microwave Ablation Equipment | Notice No.93 2021, NMPA |
| 35 | Guidelines for Registration and Review of Power Equipment for Endoscopic surgery | Notice No.93 2021, NMPA |
| 36 | Guidelines for Registration and Review of Clinical Trials of Non- original Concomitant Diagnostic Reagents of Antitumor Drugs | Notice No.95 2021, NMPA |
| 37 | Guidelines for Registration and Review of Overseas Clinical Trial Data Using in vitro diagnostic reagents | Notice No.95 2021, NMPA |
| 38 | Guidelines for Registration and Review of Non- vascular Lumen Guide Wire Products | Notice No.102 2021, NMPA |
| 39 | Guidelines for Registration and Review of Anesthesia Mask Products | Notice No.102 2021, NMPA |
| 40 | Guidelines for Registration and Review of Disposable Minimally Invasive Fascia Closure | Notice No.102 2021, NMPA |
| 41 | Guidelines for Orthodontic Wire Registration Review | Notice No.102 2021, NMPA |
| 42 | Guidelines for Registration and Review of Disposable ureteral guide sheath | Notice No.102 2021, NMPA |
| 43 | Guiding principles for Registration and Review of Passive Surgical Instruments under Arthroscopy | Notice No.102 2021, NMPA |
| 44 | Guidelines for the Registration and Review of circumcision stapler | Notice No.102 2021, NMPA |
| 45 | Guidelines for Registration and Review of Dental Desensitizer | Notice No.102 2021, NMPA |
| 46 | Guidelines for Product Registration and Review of Funnel Chest Forming System | Notice No.103 2021, NMPA |
| 47 | Guidelines for Registration and Review of Guidelines for Registration and Review of Artificial Ligamentrtificial Ligament | Notice No.103 2021, NMPA |
| 48 | Guidelines for Registration and Review of Auditory Osicle Prosthesis Products | Notice No.103 2021, NMPA |
| 49 | Guidelines for Registration and Review of Disposable Abdominal Puncture Device | Notice No.103 2021, NMPA |
| 50 | Guidelines for Registration and Review of Extracorporeal Membrane Oxygenation (ECMO) Circulatory kits | Notice No.103 2021, NMPA |
| 51 | Guidelines for Registration and Review of Fluorescence Immunochromatography Analyzer | Notice No.104 2021, NMPA |
| 52 | Guiding Principles for registration and review of network atomizer | Notice No.103 2021, NMPA |
| 53 | Guidelines for Registration and Review of Medical Diagnostic X-ray Equipment Including Pediatric Applications | Notice No.103 2021, NMPA |
| 54 | Guidelines for Registration and Review of Transcranial Doppler Ultrasound Blood Flow Analyzer | Notice No.103 2021, NMPA |
| 55 | Guidelines for Registration and Review of Hydrogen Peroxide Sterilizers | Notice No.103 2021, NMPA |
| 56 | Guiding Principles for Registration and Review of Neonatal Blue Light Therapeutic Instrument | Notice No.103 2021, NMPA |
| 57 | Guidelines for Root Canal Preparation Machine Registration Review | Notice No.103 2021, NMPA |
| 58 | Guidelines for Registration and Review of Blood Cell Analyzer | Notice No.104 2021, NMPA |
| 59 | Guidelines for Gait Training Equipment Registration Review | Notice No.104 2021, NMPA |
| 60 | Guidelines for Registration and Review of Pepsinogen I / II Testing Reagents | Notice No.1042021, NMPA |
| 61 | Prothrombin Time / Activated Partial Thromboplastin Time / Thrombin Time / Fibrinogen Test Reagent Product Registration Review Guidelines | Notice No.104 2021, NMPA |
| 62 | Guidelines for Registration Review of Retinol Binding Protein Assay Kit (immunoturbidimetry) | Notice No.104 2021, NMPA |
| 63 | Guidelines for Registration and Review of Folic Acid Determination Reagents | Notice No.104 2021, NMPA |
| 64 | Guidelines for Registration and Review of Anti- mullerian Hormone AssayReagents | Notice No.104 2021, NMPA |
