Total 67 Guidance Documents Were Issued by CMDE in the year 2023

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