title status date Guideline on Metal Plate Internal Fixation System Final 17-Jan Guideline on Disposable High Pressure Contrast Syringe and Accessories Final 17-Jan Biosafety Cabinet Registration and Review Guideline Final 19-Jan Guideline on Medical Device Product Technical Requirements (PTR) Final 9-Feb Guideline on Research for Uniformity of Physical and Chemical Properties of Additively Manufactured Metal Implants Final 1-Mar Announcement on Matters Concerning the Filing of Class I Medical Devices Draft 2-Mar Guideline on Laser Selective Melting Metal Materials for Additive Manufacturing of Prosthodontics Final 3-Mar Guideline for Medical Device Software Registration Final 9-Mar Guideline for Artificial Intelligence in Medical Devices Registration Final 9-Mar Guideline for Medical Device Cybersecurity Final 9-Mar Guidelines for Registration Review of Ophthalmic Laser Photocoagulation Machines Final 9-Mar Key Points of Technical Review for Registration of Novel Coronavirus Antigen Detection Reagents (Trial) Final 14-Mar Guidelines for Registration Review of Intravascular Guide Wire Final 16-Mar Guidelines for Stability Studies of Passive Implantable Medical Devices Final 16-Mar Key Points of Technical Review for Laparoscopic Surgical System Final 31-Mar Key Points of Technical Review for 3D Printing Interbody Cage Final 31-Mar Key Points of Technical Review for the Evaluation of Detection Ability of New Coronavirus Mutant Strains Final 31-Mar Key Points of Technical Review for Medical Electron Linear Accelerator Final 31-Mar Key Points of Technical Review for Esophageal Stent Final 31-Mar Key Points of Technical Review for Pre-filled Catheter Irrigators Final 31-Mar Guideline on CT Image-Assisted Detection Software for Pulmonary Nodules Final 26-May Key Points of Technical Review for Changes in Raw Materials of Nitrocellulose Membranes for Novel Coronavirus (2019-nCoV) Antigen Detection Reagents Draft 26-May Guideline on Fundus Image-Assisted Diagnosis Software for Diabetic Retinopathy Final 2-Jun Guideline on Nomenclature of Active Surgical Devices Final 2-Jun Guideline on Nomenclature of Physical Therapy Devices Final 2-Jun Guideline on Nomenclature of Patient-Carrying Devices Final 2-Jun Guideline on Nomenclature of Ophthalmic Devices Final 2-Jun Guideline on Nomenclature of Infusion, Nursing and Protective Devices Final 2-Jun Guideline on Nomenclature of Clinical Testing Devices Final 2-Jun Guideline on Drug-Coated Balloon Dilatation Catheters Draft 22-Jun 2021 Medical Device Guidelines Revisions Plan Final 23-Jun Guideline on Acupuncture Needle Draft 23-Jun Guideline on Disposable Sterile Triangular Needle Draft 23-Jun Guidelines for the Registration Review of Chinese Medicine Fumigation Therapy Equipment Draft 23-Jun Guideline on Small Needle Knife Draft 23-Jun Guideline on Electric Cupping Devices Draft 23-Jun Guideline on Blood Glucose Monitoring System for Self-Measurement Draft 23-Jun Guideline on Quantitative Detection Reagents for Tumor Markers Draft 23-Jun Guideline on Materials of Influenza Virus Antigen Detection Reagents Draft 23-Jun Guideline on Influenza Virus Nucleic Acid Detection Reagent Draft 23-Jun Guideline on Pathogen-Specific M-Type Immunoglobulin Qualitative Detection Reagents Draft 23-Jun Guideline on Hepatitis B Virus DNA Quantitative Detection Reagents Draft 23-Jun Guideline on Drug Abuse Detection Reagents Draft 23-Jun Guideline on Gene Mutation Detection Reagents Related to Individualized Tumor Therapy Draft 23-Jun Guideline on Toxoplasma, Rubella Virus, Cytomegalovirus, Herpes Simplex Virus Antibody and G-type Immunoglobulin Antibody Affinity Detection Reagents Draft 23-Jun Guideline on Instruction for Use of In Vitro Diagnostic Reagents Draft 23-Jun Clinical Trials of PD-L1 Detection Reagents—Guideline on Result Reproducibility Studies Final 27-Jun Guideline on Original Companion Diagnostic Reagents Developed Simultaneously with Antitumor Drugs Final 28-Jun Guideline on Hemodialysis Concentrates Draft 28-Jun Guideline on Hemodialyzer Registration Review Draft 28-Jun Guideline on Medical Needle-Free Syringes Draft 11-Jul Technical Guideline for Compliance with Fundamental Principles of Medical Device Safety and Performance Final 13-Jul Key Points of Technical Review of Monkeypox Virus Nucleic Acid Detection Reagents (Trial) Final 15-Jul Guideline on Laparoscopic Surgical Systems Part 1: Surgical Instruments Draft 20-Jul Announcement of NMPA on Matters Concerning the Filing of Class I Medical Devices Final 11-Aug Explanation on the Revision of the Announcement on Matters Concerning the Filing of Class I Medical Devices Final 11-Aug Guideline on Remote Monitoring System Draft 22-Aug Guideline on Vascular Interventional Devices with Lubricating Coatings Draft 23-Aug Technical Review Points of Novel Coronavirus Nucleic Acid Sampling Equipment in Oropharynx (Trial) Final 26-Aug Guideline on Quantitative Detection In Vitro Diagnostic Reagent Analysis Performance Evaluation Final 26-Aug Guidelines for the Registration Review of Radio Frequency Beauty Equipment Draft 26-Aug Guideline on Percutaneous Enteral Nutrition Catheters Draft 26-Aug Guidelines for Registration Review of Disposable Human Arterial Blood Samplers Draft 26-Aug Guideline on Registration of Approved Class II Medical Devices Moving into Guangdong Province (Trial) Final 29-Aug Guidelines for the Safety and Efficacy Evaluation of Medical Devices Using Nanomaterials Part II: Physical and Chemical Characterization Draft 31-Aug Medical Device Registration Filing Review Requirements Final 1-Sep Medical Device Modification Registration Filing Review Requirements Final 1-Sep Filing Review Requirements for Medical Device Exempted from Clinical Evaluation Catalog Final 1-Sep Medical Device Clinical Evaluation Filing Review Form Final 1-Sep In Vitro Diagnostic Reagent Registration Filing Review Requirements Final 1-Sep In Vitro Diagnostic Reagents Modification Registration Filing Review requirements Final 1-Sep Filing Review Form for In Vitro Diagnostic Reagents Clinical Evaluation (Non-Clinical Trials) Final 1-Sep Filing Review Form for In Vitro Diagnostic Reagents Clinical Evaluation (Clinical Trials) Final 1-Sep Filing Review Requirements for Medical Device Clinical Trial Application Final 1-Sep Filing Review Requirements for Medical Device Renewal Registration Final 1-Sep Filing Review Requirements for In Vitro Diagnostic Reagent Renewal Registration Final 1-Sep Guidelines for Registration Review of Disposable Blood Separation Devices Draft 1-Sep Guideline on Sterilized Cotton Balls Draft 6-Sep Guideline on Liquid Chromatography Tandem Mass Spectrometry System Draft 6-Sep Guideline on Ophthalmic Optical Measuring Equipment Draft 13-Sep Guideline on Fibrin Monomer Assay Reagent Final 15-Sep Guideline on Vascular Clip Final 15-Sep Guideline on Estradiol Detection Reagent Final 15-Sep Guideline on Prealbumin Detection Reagent Final 15-Sep Guideline on Glycated Hemoglobin Analyzer Final 15-Sep Guideline on Disposable EEG Electrodes Final 15-Sep Guideline on High Sensitivity Cardiac Troponin Detection Reagent Final 15-Sep Guideline on Medical Sterile Ultrasound Couplant Final 15-Sep Guideline on Cyclosporine and Tacrolimus Detection Reagent Final 15-Sep Guideline on Heart-shaped Fatty Acid Binding Protein Assay Reagent Final 15-Sep Guideline on Acid Oxidation Potential Water Generator Final 15-Sep Guideline on Fecal Calprotectin Detection Reagent Final 15-Sep Guideline on Central Oxygen Supply System Final 15-Sep Guideline on Dental Sandblasting Powder Final 15-Sep Guideline on Fungal (1-3)-β-D Glucan Assay Reagent Final 15-Sep Guideline on Dental Root Canal Lubricant Cleaner Final 15-Sep Guideline on Qualitative Detection In Vitro Diagnostic Reagent Analysis Performance Evaluation Final 28-Sep Guideline on  In Vitro Diagnostic Reagent Reference Range Determination Final 28-Sep Guideline on Quality Control Product – Research on Quality Control Product Assignment Final 28-Sep Guideline on Hepatitis E Virus IgM/IgG Antibody Detection Reagents Final 28-Sep Guideline on Human Immunodeficiency Virus Antigen and Antibody Detection Reagents Final 28-Sep Guideline on EBV Antibody Detection Reagents Final 28-Sep Guideline on Extracorporeal Membrane Oxygenation (ECMO) Temperature Control Devices Draft 28-Sep Guideline on Mobile ECG and Atrial Fibrillation Detection Products Draft 28-Sep Guideline on Continuous Glucose Monitoring Systems Draft 28-Sep Guideline on Non-invasive Blood Glucose/Glucose Monitoring Products Draft 28-Sep Guideline on Single-Use Infusion Sets Draft 8-Oct Guideline on Disposable Light-Proof Infusion Sets Draft 8-Oct Guideline on Zika Virus Nucleic Acid Detection Reagents Draft 8-Oct Guideline on Brucella IgM/IgG Antibody Detection Reagents Draft 8-Oct Guideline on Hepatitis C Virus Antibody Detection Reagents Draft 8-Oct Guideline on Clinical Trials of Non-Small Cell Lung Cancer-Related Gene Mutation Detection Reagents based on High-Throughput Sequencing Technology Draft 8-Oct Guideline on Intense Pulsed Light Therapy Devices Draft 8-Oct Guideline on Artificial Shoulder Prosthesis Draft 8-Oct Guideline on Dental Adhesive Product Draft 8-Oct Guideline on Non-Vascular Self-Expanding Metal Stent System Draft 8-Oct Guideline on Endovascular Retrieval Devices Draft 8-Oct Guideline on Hernia Repair Mesh Product Draft 8-Oct Guideline on Contact Lens Care Products Draft 8-Oct Guideline on Single-use intravenous Nutrition Infusion Bags Draft 10-Oct Guideline on for Insulin Pump Draft 12-Oct Guideline on High Flow Respiratory Therapy Devices Draft 12-Oct Clinical Evaluation Registration Review Guideline of Hip Prosthesis for Predicate Comparison Draft 24-Oct Clinical Evaluation Registration Review Guideline of Interbody Cage for Predicate Comparison Draft 24-Oct Clinical Evaluation Registration Review Guideline of Positron Emission/X-ray Computed Tomography System for Predicate Comparison Draft 24-Oct Clinical Evaluation Registration Review Guideline of Medical X-ray Diagnostic Device (Class 3) for Predicate Comparison Draft 24-Oct Clinical Evaluation Registration Review Guideline of Laser Therapy Device for Predicate Comparison Draft 24-Oct Clinical Evaluation Registration Review Guideline of Soft Contact Lens for Predicate Comparison Draft 24-Oct Clinical Evaluation Registration Review Guideline of Hemodialysis Concentrate Predicate Comparison Draft 24-Oct Ultrasound Soft Tissue Surgery Guideline Draft 24-Oct Guidelines for Optical Radiation Safety of Medical Devices Draft 27-Oct Guideline on Main Raw Materials Research of In Vitro Diagnostic Reagents Draft 1-Nov Guideline on Herpes Simplex Virus (HSV) Nucleic Acid Detection and Typing Reagents Draft 1-Nov Guideline on Tumor Markers Quantitative Detection Reagents Draft 1-Nov Guideline on Drug Abuse Detection Reagents Draft 1-Nov Guideline on Instruction for Use for In Vitro Diagnostic Reagent Draft 1-Nov Guideline on Invasive Blood Pressure Monitoring Products Draft 12-Nov Guideline on Invasive Pressure Sensors Draft 12-Nov Guideline on Bladder Ultrasound Scanner Draft 12-Nov Guideline on Implantable Medical Device Batteries Draft 12-Nov Guideline on Single-use Epidural Catheters Draft 12-Nov Guideline on Quantitative Shear Wave Ultrasound Liver Measuring Instrument Draft 12-Nov Guideline on Clinical Study of Human Immunodeficiency Virus Detection Reagents Draft 12-Nov Guideline on Aspergillus Nucleic Acid Detection Reagent Draft 12-Nov Guideline on Motor Neuron Survival Gene 1 (SMN1) Detection Reagent Final 12-Nov Guideline for Evaluation of Safety and Efficacy of Medical Devices Using Nanomaterials Part III: Biocompatibility/Toxicological Evaluation Draft 12-Nov Guideline on Single-use Cardiac Fixator Final 12-Nov Guideline on Single-use Medical Irrigators Final 12-Nov Guideline on Non-absorbent Surgical Sutures Final 12-Nov Guideline on Single-use Sterile Vaginal Dilator Final 18-Nov Guideline on Oral Impression Material Final 18-Nov Guideline on Stone Taking Net Basket Final 18-Nov Guideline on Transnasal Bile External Drainage Tube Final 18-Nov Guideline on Phosphoric Acid Etching Agent for Dentistry Final 18-Nov Guideline on Pit and Fissure Sealant Final 18-Nov Guideline on Single-use Delivery Kits Final 18-Nov Guideline on Disposable Use of Peripheral Lancets Final 18-Nov Guideline on Face Shields, Masks, and Nasal Masks for Continuous Positive Pressure Ventilation Final 22-Nov Guideline on Braceless Appliance Final 22-Nov Guideline on Medical Suture Needles Final 22-Nov Guideline on Hysterosalpingogram Balloon Catheter Final 22-Nov Guideline on Transnasoenteral Nutrition Catheter Final 22-Nov Guideline on Single-use Cervical Balloon Dilation Catheter Final 22-Nov Guideline on Ureteral Stents Final 26-Nov Guideline on Orthodontic brackets Final 26-Nov Guideline on Acupuncture Needles Final 26-Nov Guideline on Single-use Sterile Triangular Needle Final 26-Nov Guideline on Traditional Chinese Medicine Fumigation Treatment Equipment Final 26-Nov Guideline on Electric Cupper Final 26-Nov Guideline on Disinfectant Pads Final 26-Nov Guideline on Liquid Chromatography Tandem Mass Spectrometry System Final 26-Nov Guideline on Submission Materials of Blood Glucose Monitoring System for Self-testing Final 2-Dec Guideline on Registration of Detection of Gene Mutations Associated with Tumor Individualized Therapy Draft 2-Dec Guideline on Registration of Hepatitis B virus Deoxyribonucleic Acid Quantitative Detection Reagent Draft 2-Dec Guideline on Registration of Influenza Virus Antigen Detection Reagent Draft 2-Dec Guideline on Registration of Nucleic Acid Detection Reagent for Influenza Virus Draft 2-Dec Guideline on Registration of Antibodies to Toxoplasma Gondii, Rubella Virus, Cytomegalovirus, Herpes Simplex Virus, and G Type Immunoglobulin Antibody Detection Reagent Draft 2-Dec Guideline on Registration of Pathogen specific M-type Immunoglobulin Qualitative Detection Reagent Draft 2-Dec Key Points of Technical Review of Recombinant Human Collagen Injection Materials for Plastic Surgery Final 29-Dec Key Points of Technical Review of Implantable Neurostimulators Final 29-Dec Key Points of Technical Review of Clinical Trial Data of Hepatitis B Virus Pre-S1 Antigen Detection Reagent Final 29-Dec

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