Guidelines for Medical Device Registration Review in 2023 Prepare Plan

Formulation plan for guiding principles for registration review of Class III medical devices

In order to further strengthen the guiding role of the guiding principles for medical device registration review in the registration application and technical review work, the CMDE organized and drafted a compilation plan for the guidelines for medical device registration review, which is now released.

serial number	Guiding Principle Name
1	Guidelines for Registration Review of Nitric Oxide Therapeutic Devices
2	Hemodialysis equipment registration review guidelines
3	Guidelines for registration review of X-ray flat panel detection and imaging systems
4	Guiding Principles for Registration Review of Single Photon Emission/X-ray Computed Tomography System
5	Positron emission/magnetic resonance imaging system registration review guidelines
6	Guiding principles for special registration review of X-ray computed tomography equipment energy spectrum technology
7	Guidelines for Registry Review of Laparoscopic Surgical Systems Part 3: Three-dimensional Laparoscopy
8	Guidelines for registration review of high-frequency surgical instruments for flexible endoscopes
9	Corneal Topographer Registration Review Guidelines
10	Guiding Principles for Compiling Medical Device Instructions
11	Laparoscopic Surgical System Registration Review Guidelines Part 2: Animal Test Decision-Making Judgment and Requirements
12	Guidelines for Registry Review of Intracranial Coils
13	Peripheral Vascular Stent Registration Review Guidelines
14	Guidelines for registration review of thrombectomy stents
15	Guiding Principles for Registration Examination of Metallic Cable/Cable System
16	Guidelines for registration review of laminar fixation systems
17	Guiding Principles for Registration and Review of Gut Gum Tips
18	Guidelines for registration review of single-use side-hole blunt needles
19	Guidelines for registration review of single-use intravenous indwelling catheters
20	Dialysate Filter Registration Review Guidelines
21	Guidelines for Registration Review of Hydrogel Dressing Products
22	Guidelines for registration review of human MTHFR gene polymorphism detection reagents
23	Guidelines for registration review of ALDH2 gene polymorphism detection reagents
24	Guiding Principles for Registration Review of HLA-B27 Gene Detection Reagents
25	Guiding principles for registration review of stability studies of in vitro diagnostic reagents
26	Guiding Principles for Registration Review of PD-L1 Detection Reagents
27	Guiding principles for registration review of clinical trials of gene methylation detection reagents for auxiliary diagnosis of colorectal cancer
28	Guiding principles for registration review of antibiotic susceptibility testing reagents
29	Guidelines for registration review of clinical trials of drug-coated balloon dilatation catheters
30	Guidelines for clinical evaluation and registration review of thermal ablation therapy systems (radiofrequency, microwave, etc.)
31	Guiding principles for registration review of clinical evaluation of intracranial aneurysm embolization system
32	Guiding principles for clinical evaluation registration review of medical linear accelerators
33	Guiding principles for registration review of clinical trials of artificial intelligence-assisted detection of medical devices
34	ECMO system clinical evaluation registration review guidelines
35	Guidelines for registration review of clinical trials of facial injection filling materials
36	Guiding principles for clinical evaluation registration review of intracranial thrombectomy stents

Revision Plan for Guidelines for Registration Review of Class III Medical Devices

serial number	Guiding Principle Name
37	Guidelines for Registration Review of Mobile Medical Devices (2023 Revision)
38	Guiding Principles for Registration Review of Centrifugal Blood Component Separation Equipment (2023 Revision)
39	Guidelines for Registration Review of Medical Magnetic Resonance Imaging Systems (2023 Revision)
40	Guidelines for Registry Review of Therapeutic Ventilators (2023 Revision)
41	Guidelines for Registration Review of Cardiac Radiofrequency Ablation Devices (2023 Revision)
42	Guidelines for Registration Review of High-Frequency Surgical Equipment (2023 Revision)
43	Ophthalmic phacoemulsification and anterior segment vitrectomy equipment and accessories registration review guidelines (2023 revision)
44	Guiding Principles for Registration Review of Imaging Ultrasound Diagnostic Equipment
45	Guidelines for Registry Review of Spinal Fixation Systems (Revised in 2023)
46	Intervertebral fusion cage registration review guidelines (revised in 2023)
47	Dental implant (system) registration review guidelines (revised in 2023)
48	α-cyanoacrylate medical adhesive registration review guidelines (2023 revision)
49	Registration Review of Disposable Membrane Oxygenators (2023 Revision)
50	Guidelines for Registration Review of Absorbable Hemostatic Products (2023 Revision)
51	Guidelines for the registration review of absorbable anti-adhesion products for abdominal and pelvic surgery (2023 revision)
52	Registry Review Guidelines for Absorbable Surgical Sutures (2023 Revision)
53	Guidelines for Registry Review of Disposable Hydrocephalus Shunts (2023 Revision)
54	Guidelines for registration review of single-use hemodialysis tubing (2023 revision)
55	Estrogen receptor, progesterone receptor antibody reagents and detection kit registration review guidelines (2023 revision)
56	Guidelines for registration review of hepatitis B virus genotyping detection reagents (2023 revision)
57	Guidelines for registration review of nucleic acid detection reagents for Mycobacterium tuberculosis complex (2023 revision)
58	Guiding Principles for Registration Review of Human Papillomavirus (HPV) Nucleic Acid Detection and Genotyping Reagents (2023 Revision)
59	allergen-specific IgE antibody detection reagents (2023 revision)
60	Hepatitis C virus ribonucleic acid assay reagent registration review guidelines (2023 revision)
61	of Fully Automatic Chemiluminescence Immunoassay Analyzers ( 2023 Revision)
62	Guidelines for registration review of human erythrocyte antityping reagents (2023 revision)
63	Guiding Principles for Division of Medical Device Registration Units (2023 Revision)

Formulation plan for guiding principles for registration review of Class II medical devices

serial number	Guiding Principle Name
64	Guiding Principles for Registration Review of Electric Photography Flat Beds
65	Guiding Principles for Registration Review of Medical Gas Alarm System
66	Air-oxygen mixer product registration review guidelines
67	Guiding Principles for Product Registration Review of Laser Positioning System
68	Guidelines for Registration Review of Internal Electrodes for Nerve and Muscle Stimulators
69	Guiding Principles for Product Registration Review of TCM Pulse Diagnosis Equipment
70	Guiding Principles for Registration Review of Rehabilitation Training Beds
71	Guiding principles for registration review of medical gynecological gel
72	Guiding Principles for Registration Review of Oxygen Inhalation Mask Products
73	Guiding Principles for Nebulized Mask Product Registration Review
74	Bronchial occluder registry review guidelines
75	Guidelines for Registration Review of Medical Catheter Fixtures
76	Guidelines for Respiratory Mask Registration Review
77	Guiding Principles for Registration Review of Assisted Reproductive Catheter Products
78	Guiding principles for registration review of medical sodium hyaluronate wound dressing
79	Guidelines for the registration review of recombinant collagen wound dressings
80	Electrolyte Analyzer Registration Review Guidelines
81	Glucose detection kit registration review guidelines
82	Guidelines for the registration review of reagents for the identification of gram-negative bacilli
83	Guidelines for registration review of pyruvate detection reagents
84	α-amylase detection reagent registration review guidelines
85	α-Hydroxybutyrate dehydrogenase detection reagent registration review guidelines
86	Guiding Principles for Registration Review of Magnesium Detection Reagents

Revision Plan for the Guiding Principles for Registration Review of Class II Medical Devices

serial number	Guiding Principle Name
87	Guidelines for registration review of semi-automatic chemiluminescence immunoassay analyzers ( 2023 revision)
88	Guidelines for Registration Review of Dental Units (2023 Revision)
89	Hearing Aid Registration Review Guidelines (2023 Revision)
90	Guidelines for Registration Review of X-ray Diagnostic Equipment (Class II) (2023 Revision)
91	Guidelines for Registration Review of Medical Nebulizers (2023 Revision)
92	Creatine Kinase Assay Reagent (Kit) Registration Review Guidelines (2023 Revision)
93	Guidelines for Registration Review of Positive Pressure Ventilation Therapy Machines (2023 Revision)
94	Guiding Principles for Registration Review of Magnetic Therapy Products (2023 Revision)
95	Coagulation Analyzer Registration Review Guidelines (2023 Revision)
96	Guidelines for Registration Review of Cold Light Sources for Medical Endoscopes (2023 Revision)
97	Sialic acid detection kit (enzymatic method) registration review guidelines (2023 revision)
98	β2-microglobulin detection kit (latex-enhanced immunoturbidimetric method) registration review guidelines (2023 revision)
99	Guidelines for Registration Review of Lactate Dehydrogenase Assay Kit (2023 Revision)
100	Guiding Principles for Registration Review of Thyrotropin Detection Reagents (2023 Revision)
101	Guidelines for registration review of ischemia-modified albumin assay kits ( 2023 revision)
102	Glycated hemoglobin assay kit (enzymatic method) registration review guidelines (2023 revision)
103	Guiding principles for registration review of vibration percussion expectoration machine (revised version in 2023)
104	Urine Analyzer Registration Review Guidelines (2023 Revision)
105	Guidelines for registration review of peritoneal dialysis machines (2023 revision)
106	C-reactive protein assay kit registration review guidelines (2023 revision)
107	Medical image storage and transmission software (PACS) registration review guidelines (2023 revision)
108	Guidelines for Registration Review of Automated Urine Formed Component Analyzers ( 2023 Revision)
109	Guidelines for Registration Review of Large Steam Sterilizers ( 2023 Revision)
110	Alkaline Phosphatase Assay Kit Registration Review Guidelines (2023 Revision)
111	Guiding principles for registration review of water-making equipment for hemodialysis (2023 revision)
112	Guidelines for Registration Review of Triglyceride Determination Kits (2023 Revision)
113	Guidelines for Registration Review of Blood Glucose Meters (2023 Revision)
114	Human chorionic gonadotropin detection reagent (colloidal gold immunochromatography) registration review guidelines (2023 revision)
115	Guidelines for Registration Review of Albumin Determination Reagents (Boxes) (2023 Revision)
116	Fecal occult blood (FOB) detection kit (colloidal gold immunochromatography) registration review guidelines (2023 revision)
117	Guidelines for registration review of electronic sphygmomanometer (oscillometric method) (2023 revision)
118	Guidelines for Registration Review of Biochemical Analyzers ( 2023 Revision)