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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