China medical device regulations

Comprehensive collection of NMPA laws and regulations including the revised Good Manufacturing Practice for Medical Devices (effective November 2026).

SAMR Decree No. 47 as published in NMPA English. Authority English is a translation; the Chinese expression controls. Articles 1–124 are ingested from the official HTML page. Covers Class I filing, Class II/III registration, and technical documentation requirements.

Current consolidated Chinese expression of the Regulations on Supervision and Administration of Medical Devices, downloaded from the Ministry of Justice National Administrative Regulations Database. It incorporates the December 6, 2024 amendments effective January 20, 2025 — still the newest MOJ edition (re-downloaded 29 August 2026, byte-identical, all content assertions passing). Articles 1–107 and Chapters I–VIII are ingested; Chinese is the controlling text.

Official NMPA portal for medical device news, announcements, and regulatory updates. Covers policy measures to advance drug and medical device regulation reform.

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).