Medical Device Post-Market Surveillance（医械上市后监管）
A practical playbook for post-market surveillance of medical devices, comparing reporting duties across the US, EU, China and Japan and turning them into checklists. It covers adverse event reporting, PSUR frequency, field safety corrective actions, recalls and PMCF follow-up. Use when you need to k
as observed 2026-11-06T15:44:01.797Z- Identifier
medical-device-postmarket- Source
- ClawHub
- Version observed
- 1.1.4
- Source repository
- not published
- Repository observation
- No source repository listed
- First observed here
- 2026-08-28T22:06:28.212Z
- Observations recorded
- 2
- Installs (reported upstream)
- 1
- Weekly downloads (upstream)
- 475
- Declared license
- MIT-0
Observation history
2026-11-06T15:44:01.797Z
Fields that differed: license changelog description latestVersion summary
| Field | Before | After |
|---|---|---|
license |
null | "MIT-0" |
changelog |
"v1.1.0: published edition - medical device post-market surveillance playbook, four-market (US/EU/CN/JP) obligation comparison (adverse event reporting, PSUR, FSCA/recall, PMCF), r | "安全面加固：permissions 声明改为与包内脚本实际能力一致；新增「数据处理边界」段，明确默认不外发、需人指定目的地并逐次确认。业务逻辑未改动。" |
description |
"医疗器械上市后监管（Post-Market Surveillance, PMS）实操手册——中美欧日四市场上市后义务对照（不良事件报告、PSUR 定期安全报告、FSCA/召回现场安全纠正、PMCF 上市后临床跟踪）、各市场报告时限与流程清单（美国 21 CFR 803 致死 30 天/严重 90 天、欧盟 MDCG 2022-21 PSUR 频率、中国 2 | null |
latestVersion |
"1.1.0" | "1.1.4" |
summary |
"医疗器械上市后监管（Post-Market Surveillance, PMS）实操手册——中美欧日四市场上市后义务对照（不良事件报告、PSUR 定期安全报告、FSCA/召回现场安全纠正、PMCF 上市后临床跟踪）、各市场报告时限与流程清单（美国 21 CFR 803 致死 30 天/严重 90 天、欧盟 MDCG 2022-21 PSUR 频率、中国 2 | "A practical playbook for post-market surveillance of medical devices, comparing reporting duties across the US, EU, China and Japan and turning them into checklists. It covers adv |
Correction
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