NMPA Medical Device Classification

China's classification is based on risk level and uses a Classification Catalog (分类目录) organized by device type.

Classification Rules

• Class I — Low risk, general controls, filing (备案)
• Class II — Moderate risk, special controls, provincial registration
• Class III — High risk, premarket approval, national registration

Classification Catalog Structure

The 2017 Classification Catalog (医疗器械分类目录) organizes devices into 22 categories (01–22):

Category	Device Type
01	Active implantable devices
02	Anesthesia and respiratory devices
03	Cardiovascular devices
04	Clinical laboratory instruments
05	Dental devices
06	Ear, nose, throat devices
07	Gastroenterology/urology devices
08	General hospital devices
09	Implantable materials
10	Diagnostic imaging devices
11	IVD reagents
12	Laser equipment
13	Maternal and infant devices
14	Medical high-frequency equipment
15	Medical optical instruments
16	Medical ultrasound equipment
17	Neurology devices
18	Orthopedic devices
19	Physical therapy devices
20	Radiation devices
21	Surgical instruments
22	Traditional Chinese medicine devices

Source

NMPA Classification Catalog