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外 Waitan Ludi Policy Terminal China industrial-policy monitor · updated 2026-10-25
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体外诊断试剂注册与备案管理办法

Measures for the Administration of the Registration and Filing of In Vitro Diagnostic Reagents

国家市场监督管理总局令第48号 · 国家市场监督管理总局 · dated 2021-08-26, 1902 days ago

5 / 31
provinces with a held document citing it
1 / 6
of the provinces whose provincial-government documents are listed in full
9
local documents citing it: 2 prefecture, 7 province
past window
Past the usual window (2021-11-18 to 2022-05-12): three in four restatements we measured came within 259 days.

Found by citation: a local document that names this directive by its number or 《title》. One that restates it without naming it is not counted here. A citation shows the document names the directive, not that it carries all of it out, and a gap is not a finding of non-compliance.

Timeline

day 0day 1902
● large: provincial document · small: city or countyshaded: middle half of measured lags (84–259 days), dashed: mediansolid line: today

By province

The first held document from each province that cites the directive: from the provincial government, its departments, or a city or county. In the 6 provinces marked "full" we hold the provincial government's own document list (省政府 and its General Office), so a gap there is more telling; but a response can come from a department, be published outside that list, or name the directive without its number or title. Elsewhere "none found" may only mean we have not collected the document.

Beijing · full
2022-06-15 · 293 days · province · 5 docs
Hebei
2023-02-17 · 540 days · prefecture
Xinjiang
2025-03-01 · 1283 days · province
Shanghai
2025-07-29 · 1433 days · province
Shandong
2025-08-22 · 1457 days · prefecture
Anhui · full
none found; provincial list held
Fujian · full
none found; provincial list held
Guangdong · full
none found; provincial list held
Hainan · full
none found; provincial list held
Hunan · full
none found; provincial list held
Chongqing
none found (partial coverage)
Gansu
none found (partial coverage)
Guangxi
none found (partial coverage)
Guizhou
none found (partial coverage)
Heilongjiang
none found (partial coverage)
Henan
none found (partial coverage)
Hubei
none found (partial coverage)
Inner Mongolia
none found (partial coverage)
Jiangsu
none found (partial coverage)
Jiangxi
none found (partial coverage)
Jilin
none found (partial coverage)
Liaoning
none found (partial coverage)
Ningxia
none found (partial coverage)
Qinghai
none found (partial coverage)
Shaanxi
none found (partial coverage)
Shanxi
none found (partial coverage)
Sichuan
none found (partial coverage)
Tianjin
none found (partial coverage)
Tibet
none found (partial coverage)
Yunnan
none found (partial coverage)
Zhejiang
none found (partial coverage)

What the local documents add

Measures the keyword screen finds in the citing documents (unreviewed leads), and how many restrict applicants to locally registered firms.

Tax relief · 1

Every citing document

2022-06-15 +293d Beijing 北京市药品监督管理局 北京市市场监管综合执法总队关于印发《北京市医疗器械行政处罚裁量基准》的通知 Notice from the Beijing Municipal Drug Administration and the Beijing Municipal Market Regulation C…
province · compare text
2022-12-28 +489d Beijing ​北京市药品监督管理局印发《北京市医疗器械注册质量管理体系优化核查指导原则(试行)》《北京市医疗器械注册质量管理体系核查中止检查指导原则(试行)》的通知 ​Notice from the Beijing Municipal Drug Administration on the Issuance of the ‘Guidance Principles …
province · compare text
2023-02-17 +540d Hebei · 保定市 3.《重点用能单位节能管理办法 3. ‘Measures for the Administration of Energy Conservation in Key Energy-consuming Units’
prefecture · Tax relief · compare text
2024-01-05 +862d Beijing 北京市医疗器械分类界定申报要求
province · compare text
2025-03-01 +1283d Xinjiang 为统一检查范围和判定标准,保证医疗器械(含体外诊断试剂,下同)临床试验检查质量,根据《医疗器械监督管理条例》《医疗器械注
province · compare text
2025-07-29 +1433d Shanghai 市药品监管局关于印发《上海市第二类医疗器械优先审批程序》的通知
province · compare text
2025-08-22 +1457d Shandong · 烟台市 烟台市市场监督管理局关于修改《烟台市市场监督管理局轻微违法行为不予行政处罚事项清单》的通知 Notice from the Yantai Municipal Market Supervision Administration on Amendments to the ‘List of Mi…
prefecture · compare text
2025-12-01 +1558d Beijing 北京市药品监督管理局关于印发《北京市进口医疗器械境内代理人监督管理办法(试行)》的通知 Notice from the Beijing Municipal Drug Administration on the Issuance of the ‘Measures for the Supe…
province · compare text
2026-02-10 +1629d Beijing 北京市药品监督管理局等单位关于印发《京津冀医疗器械临床试验监督检查办法(试行)》《京津冀医疗器械临床试验机构分级监督管理规定(试行)》的通知 Notice from the Beijing Municipal Drug Administration and Other Organisations on the Issuance of th…
province · compare text