NMPA ClassificationClassification Rules
Classification Rules is the official NMPA identifier for “Rules for Classification of Medical Devices”. Classification Rules is the official identifier NMPA uses for this instrument.
- Instrument
- Classification
- Full name
- Classification Rules
- Category
- Classification
- Authority source
- Chinese
- Readable HTML
- 10 articles · 1 language version
- Published
- July 14, 2015
- Effective
- January 1, 2016
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Rules for Classification of Medical Devices
Rules for Classification of Medical Devices (CFDA Order No. 15, published July 14, 2015, effective January 1, 2016). Controlling Chinese expression ingested from the Ministry of Justice departmental-rules database: Articles 1–10 plus the complete Annex classification-determination table (医疗器械分类判定表) reproduced cell-for-cell as text — all 21 usage-form rows across the four groups (passive/active × contact/non-contact), the Roman-numeral class cells, and the legend notes. The NMPA English page (english.nmpa.gov.cn/2019-10/11/c_415411.htm) is retained as the authority translation; its Annex table is image-only, which is why the corpus text is the Chinese original. Repeals the 2000 Classification Rules (former SDA Order No. 15).
Classification Rules is the official identifier NMPA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.