National Medical Device Classification Catalogue (NMDCC)
The National Medical Device Classification Catalogue (医疗器械分类目录 — NMDCC) is the definitive reference for determining whether a product is a medical device and, if so, its class. It is maintained by NMPA and published on the NMPA website.
Structure of the NMDCC
The NMDCC is divided into 22 sub-catalogues (子目录), each corresponding to a broad product area:
| Sub-catalogue | Product area |
|---|---|
| 01 | Active implantable devices |
| 02 | Anaesthesia and respiratory |
| 03 | Cardiovascular |
| 04 | Clinical laboratory |
| 05 | Dental |
| 06 | Ear, nose, throat |
| 07 | In vitro diagnostics |
| 08 | Ophthalmology |
| 09 | Orthopaedics |
| 10 | Physical therapy |
| 11 | Radiation devices |
| 12 | Reusable surgical instruments |
| 13 | Sterilisation / disinfection |
| 14 | Soft tissue surgery |
| 15 | Wound management |
| 16 | Medical imaging |
| 17 | Neurology |
| 18 | Urology |
| 19 | Obstetrics and gynaecology |
| 20 | Traditional Chinese medicine devices |
| 21 | In vitro diagnostic instruments |
| 22 | Other |
How to read a NMDCC entry
Each entry contains:
- Product code (产品类代号): a structured code combining sub-catalogue number and product type
- Classification name: the official NMPA name for the product type
- Class (管理类别): I, II, or III
- Product name examples (品名举例): illustrative examples — these are not exhaustive
Classification determination (分类界定)
If your device does not match any NMDCC entry, you must request a classification determination from NMPA before proceeding. NMPA publishes determination results, which can be useful precedents for similar products. See NMPA classification determination database for published decisions.
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.