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国家药监局关于发布《医疗器械注册自检管理规定》的公告

Announcement by the National Medical Products Administration on the Publication of the ‘Regulations on the Management of Self-Inspection for Medical Device Registration’

No document number

Radar: Medical devices (rank 13 of 16)

Same central policy, other provinces

This document · 2021-10-21 · answered in 0 provinces held · trace it ↗

Province	First document citing it	Dated	Lag

Held documents only: these are counts of what we have collected, not of what each province issued.

Full text

国家药监局关于发布《医疗器械注册自检管理规定》的公告 2021年第126号为加强医疗器械注册管理，规范注册申请人注册自检工作，确保医疗器械注册检验工作有序开展，根据《医疗器械监督管理条例》（国务院令第739号）及《医疗器械注册与备案管理办法》（市场监管总局令第47号）、《体外诊断试剂注册与备案管理办法》（市场监管总局令第48号），国家药品监督管理局组织制定了《医疗器械注册自检管理规定》，现予发布，自发布之日起施行。特此公告。国家药监局 2021年10月21日医疗器械注册自检管理规定.docx

Document

Status: In force
Issuer: 药监局
Level: National
Dated: 2021-10-21 (成文日期, from the document)
Posted on the portal: 2021-10-23
In force: 2021-10-23
Topic tree: Medical devices and equipment: 1 hop from 国务院令第739号
Topic: 市场监管、安全生产监管\食品药品监管

Original: https://www.gov.cn/zhengce/zhengceku/2021-10/23/content_564…
Government sites can be slow from outside mainland China; the text here is our stored copy.

Cites (3)

市场监管总局令第47号not held
市场监管总局令第48号not held
国务院令第739号
医疗器械监督管理条例 · 国务院

Cited by (0)

No held document cites this one yet.

Cite this

药监局：《国家药监局关于发布《医疗器械注册自检管理规定》的公告》，2021-10-21。

National Medical Products Administration, 《国家药监局关于发布《医疗器械注册自检管理规定》的公告》 [Announcement by the National Medical Products Administration on the Publication of the ‘Regulations on the Management of Self-Inspection for Medical Device Registration’], 21 October 2021.

Source: https://www.gov.cn/zhengce/zhengceku/2021-10/23…
Held copy: https://waitan-ludi.xyz/terminal/policies/11588/