In the year 2023, China CMDE issued 67 guidance documents to help technical review and application submission preparation.
The following is a list of the guidance documents:
| No. | Guidance |
| 1 | Guidance for Registration Review of Novel Coronavirus (2019-nCoV) Antigen Detection Reagent (2023 No. 2) (2023-03-02) |
| 2 | Guidance for Registration Review of Novel Coronavirus (2019-nCoV) Antibody Detection Reagent (2023 No. 2) (2023-03-02) |
| 3 | Guidance for Registration Review of Novel coronavirus (2019-nCoV) nucleic acid detection reagent (2023 No. 2) (2023-03-02) |
| 4 | Guidance for Registration Review of Artificial Shoulder Prostheses (No. 3, 2023) (2023-03-09) |
| 5 | Guidance for Registration Review of Dental Adhesive Product(2023 No. 3) (2023-03-09) |
| 6 | Guidance for Registration Review of laparoscopic surgery systems Part 1: Surgical instruments (2023 No. 5) (2023-03-23) |
| 7 | Guidance for Registration Review of Ultrasound Soft Tissue Surgery Equipment (2023 Revised Edition) (2023 No. 4) (2023-03-31) |
| 8 | Guidance for Registration Review Quantitative Shear Wave Ultrasound Liver Measurement Instruments (No. 7, 2023) (2023-04-11) |
| 9 | Guidance for Registration Review of Radiofrequency Beauty Equipment (No. 8, 2023) (2023-04-12) |
| 10 | Guidance for Guidance for IFU preparation of Soft Hydrophilic Contact Lenses (2023 Revised Edition) (2023 No. 9) (2023-04-13) |
| 11 | Guidance for Registration Review of Drug-Coated Balloon Dilatation Catheters (No. 9, 2023) (2023-04-13) |
| 12 | Guidance for Registration Review of Intravascular Recovery Devices (No. 9, 2023) (2023-04-13) |
| 13 | Guidance for IFU preparation of Rigid Contact Lenses (2023 Revised Edition) (2023 No. 9) (2023-04-13) |
| 14 | Guidance for Registration Review of Contact Lens Care Products (2023 Revised Edition) (2023 No. 9) (2023-04-13) |
| 15 | Guidance for Registration Review of Hernia Repair Patch (No. 9, 2023) (2023-04-13) |
| 16 | Guidance for Registration Review of Disposable Infusion Equipment Products (2023 Revised Edition) (2023 No. 15) (2023-04-28) |
| 17 | Guidance for Registration Review of Disposable Blood Separation Devices (2023 Revised Edition) (2023 No. 15) (2023-04-28) |
| 18 | Guidance for Registration Review of Hemodialyzer (2023 Revised Edition) (2023 No. 15) (2023-04-28) |
| 19 | Guidance for Registration Review of Hemodialysis Concentrates (2023 Revised Edition) (2023 No. 15) (2023-04-28) |
| 20 | Guidance for Registration Review of Disposable Light-Proof Infusion Sets (2023 Revised Edition) (2023 No. 15) (2023-04-28) |
| 21 | Guidance for Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials Part 2: Physical and Chemical Characterization (2023 No. 15) (2023-04-28) |
| 22 | Guidance for Registration Review of Intense Pulsed Light Therapy Equipment (2023 Revised Edition) (2023 No. 12) (2023-04-28) |
| 23 | Guidance for registration review of ophthalmic optical measurement equipment (No. 13, 2023) (2023-04-28) |
| 24 | Guidance for Registration Review of Recombinant Collagen Wound Dressings (2023 No. 16) (2023-05-23) |
| 25 | Guidance for Evaluation of Recombinant Humanized Collagen Raw Materials (2023 No. 16) (2023-05-23) |
| 26 | Guidance for Registration Review of Percutaneous Enteral Nutrition Catheter (2023 No. 17) (2023-06-06) |
| 27 | Guidance for Registration Review of Medical Needleless Injectors (No. 17, 2023) (2023-06-06) |
| 28 | Guidance for Registration Review of Disposable Human Arterial Blood Sample Collectors (No. 17, 2023) (2023-06-06) |
| 29 | Guidance for Registration Review of Disposable Intravenous Nutrition Infusion Bags (2023 No. 17) (2023-06-06) |
| 30 | Guidance for Registration Review of Clinical Evaluation of Intervertebral Fusion Cages of the Same Type (2023 No. 20) (2023-06-28) |
| 31 | Guidance for Registration Review of Intestinal Hydrotherapy Machines (No. 22, 2023) (2023-07-07) |
| 32 | Guidance for Registration Review of Medical Respiratory Humidifiers (2023 No. 22) (2023-07-07) |
| 33 | Guidance for Registration Review of Medical Molecular Sieve Oxygen Concentrators (No. 22, 2023) (2023-07-07) |
| 34 | Guidance for Registration Review of Bladder Ultrasound Scanners (No. 22, 2023) (2023-07-07) |
| 35 | Guidance for Registration Review of Single-use peritoneal dialysis catheter (2023 No. 22) (2023-07-07) |
| 36 | Guidance for Registration Review of Respiratory Filters (No. 22, 2023) (2023-07-07) |
| 37 | Guidance for registration review of blood melting equipment (No. 22, 2023) (2023-07-07) |
| 38 | Guidance for Registration Review of Gram-Positive Bacteria Identification Reagents (No. 22, 2023) (2023-07-07) |
| 39 | Guidance for registration review of anti-cyclic citrullinated peptide antibody detection reagents (2023 No. 22) (2023-07-07) |
| 40 | Guidance for Registration Review of Methotrexate Test Reagents (No. 22, 2023) (2023-07-07) |
| 41 | Guidance for Registration Review of Beta-Hydroxybutyric Acid Detection Reagents (No. 22, 2023) (2023-07-07) |
| 42 | Guidance for Registration Review of Gel dressing product (2023 No. 22) (2023-07-07) |
| 43 | Guidance for Registration Review of Liquid Dressing Products (No. 22, 2023) (2023-07-07) |
| 44 | Guidance for Registration Review of Oropharyngeal/Nasopharyngeal Airway (2023 No. 22) (2023-07-07) |
| 45 | Guidance for Registration Review of Clinical Evaluation of Ventilators of the Same Type (2023 No. 21) (2023-07-10) |
| 46 | Guidance for Registration Review of Continuous Glucose Monitoring Systems (2023 Revised Edition) (2023 No. 24) (2023-07-18) |
| 47 | Guidance for Registration Review of Transcatheter Aortic Valve System (2023 No. 25) (2023-07-18) |
| 48 | Guidance for registration review of non-vascular self-expanding metallic stent systems (2023 No. 25) (2023-07-18) |
| 49 | Guidance for registration review of vascular interventional devices with lubricating coating (2023 No. 25) (2023-07-18) |
| 50 | Benefits of Medical Device Products – Technical Guidance for Risk Determination (2023 Revised Edition) (2023 No. 25) (2023-07-18) |
| 51 | Guidance for Registration Review of Extracorporeal Membrane Oxygenation (ECMO) Temperature Control Equipment (No. 26, 2023) (2023-07-20) |
| 52 | Guidance for Registration Review of Mobile ECG Atrial Fibrillation Detection Products (No. 26, 2023) (2023-07-20) |
| 53 | Guidance for Registration Review of High-Flow Respiratory Therapy Equipment (No. 26, 2023) (2023-07-20) |
| 54 | Guidance for Registration Review of Insulin Pump (2023 No. 26) (2023-07-20) |
| 55 | Guidance for Registration Review of Clinical Evaluation of Same Types of Hip Prostheses (2023 No. 27) (2023-07-24) |
| 56 | Guidance for Registration Review of Clinical Evaluation of Similar Types of Laser Treatment Equipment (No. 28, 2023) (2023-07-31) |
| 57 | Guidance for Registration Review of Clinical Evaluation of Positron Emission/X-ray Computed Tomography Systems of the Same Type (2023 No. 31) (2023-08-04) |
| 58 | Guidance for Registration Review of Clinical Evaluation of Hemodialysis Concentrates (2023 No. 29) (2023-08-04) |
| 59 | Guidance for Registration Review of Clinical Evaluation of Similar Types of Medical X-ray Diagnostic Equipment (Category III) (2023 No. 30) (2023-08-04) |
| 60 | Guidance for Registration Review of Clinical Evaluation of the Same Type of Dental Implant System (2023 No. 32) (2023-08-14) |
| 61 | Guidance for registration review of clinical evaluation of soft contact lenses (2023 No. 33) (2023-08-23) |
| 62 | Guidance for Registration Review of Clinical Evaluation of the Same Type of Electronic Endoscopes (2023 No. 35) (2023-08-30) |
| 63 | Guidance for Registration Review of Clinical Evaluation of Artificial Intelligence-Assisted Detection Medical Devices (Software) (2023 No. 38) (2023-11-07) |
| 64 | Guidance for Registration Review of Extracorporeal Membrane Oxygenation (ECMO) Cycle Kit Animal Testing (2023 No. 39) (2023-12-06) |
| 65 | Guidance for Registration Review of Invasive Pressure Sensor Products (No. 41, 2023) (2023-12-25) |
| 66 | Guidance for Registration Review of Non-Invasive Blood Glucose Monitoring Products (No. 42, 2023) (2023-12-25) |
| 67 | Guidance for Registration Review of Invasive Blood Pressure Monitoring Products (No. 41, 2023) (2023-12-25) |