How Classification Works
China uses a risk-based three-class classification system for medical devices. Class is the single most important factor determining who regulates your device, what pathway applies, and how much GMP scrutiny you face.
The three-tier authority split — where Class I is filed with local authorities, Class II with provincial NMPA, and Class III/imported with national NMPA — is unique to China among major regulatory frameworks.
The three classes
| Class | Risk level | Regulatory control | Filing/registration authority |
|---|---|---|---|
| Class I | Low | Filing (备案) | District/county-level authority |
| Class II | Medium | Registration (注册) | Provincial NMPA bureau |
| Class III | High (or implantable / life-sustaining) | Registration (注册) | National NMPA (CMDE review) |
Imported devices of any class are registered with national NMPA, regardless of their class.
How class is determined
Classification is primarily determined by reference to the National Medical Device Classification Catalogue (NMDCC — 医疗器械分类目录). The NMDCC lists product categories, each assigned a class and a product code.
If your device is not in the NMDCC, you must request a classification determination (分类界定) from NMPA before proceeding with registration or filing.
IVDs
In vitro diagnostic reagents follow separate classification rules under the IVD Catalogue. See Classification Rules for IVDs.
Next steps
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.