There have been 181 guidelines issued by the NMPA in 2022. The revised or newly established guidelines are aimed to facilitate manufacturers with local type testing, pre-clinical, clinical trial, and regulatory submission, and make guidelines more consistent with the international counterparts.
The guidelines are prepared by the NMPA Center of Medical Device Evaluation (CMDE). It is not legally binding but highly recommended by regulatory authorities.
For both renewals and new registrations, medical devices need to meet these new guidelines. Even if renewals (required every 5 years by NMPA) have no changes, manufacturers still have to prove that the originally approved products can meet the new guidelines.
As a result, approved products still need to go through local type testing to show that they are current with these new requirements. China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.
Full List of 181 NMPA Guidelines 2022
China Med Device has summarized 2022 NMPA guidelines into a table below. Contact us at info@ChinaMedDevice.com to get the English copy of any guideline you are interested in. We charge nominal fees for the translation.
| 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 |
