NMPA Medical Device Classification Catalog

China's medical device classification uses a three-level catalog based on risk level.

Classification Rules

• Class I -- Low risk, general controls, filing
• Class II -- Moderate risk, special controls, provincial registration
• Class III -- High risk, premarket approval, national registration

Classification Catalog (2017 Edition, with Amendments)

Total: 22 L1 categories, 205 L2 subcategories, 1142 L3 product groups.

Code	Category	L2	L3
01	Active Surgical Instruments	10	25
02	Passive Surgical Instruments	15	82
03	Neurovascular Surgical Instruments	14	60
04	Orthopedic Surgical Instruments	18	95
05	Radiation Therapy Equipment	4	22
06	Medical Imaging Equipment	18	92
07	Medical Diagnostic & Monitoring Instruments	10	58
08	Respiratory, Anesthesia & Emergency Equipment	7	54
09	Physical Therapy Equipment	8	37
10	Transfusion, Dialysis & Extracorporeal Circulation Equipment	7	40
11	Medical Sterilization & Disinfection Equipment	5	15
12	Active Implantable Devices	4	26
13	Passive Implantable Devices	11	63
14	Infusion, Nursing & Protective Equipment	15	107
15	Patient Transfer Equipment	6	17
16	Ophthalmic Devices	7	80
17	Dental Devices	10	93
18	Obstetric, Gynecologic, Assisted Reproduction & Contraceptive Devices	7	37
19	Medical Rehabilitation Devices	4	18
20	Traditional Chinese Medicine Devices	3	22
21	Medical Software	6	13
22	Clinical Laboratory Instruments	16	86

Classification Determination

For products with unclear classification, NMPA issues Classification Determination Notices.

Source

• NMPA Classification Catalog (2017)