Real Skill packageSource verifiedClawHub registry

医械注册工程师·全球通关枢纽

🌐 官网：https://medxpert.cn/knowledge/（医械注册知识库·免费公开层，20+ 枢纽在线可读）。医疗器械注册工程师的「随身资料库」——中国 NMPA / 美国 FDA / 欧盟 MDR / 日本 PMDA 及东南亚·拉美全球注册路径与分类，UDI、STED 技术文件、生物相容性(ISO 10993)、GMP 质量体系、上市后监管、标签与 IFU、供应商合规等 20 个专题枢纽按「全生命周期 7 阶段」（需求立项→分类路径→技术文件→质量体系→注册申报→审评获批→上市后）全覆盖，官方直达链接一站备齐。告别资料散落、少查半天、少踩坑，从立项到拿证全程有底。119 条官方链接已浏览器级逐条核验可达。

Identity and source

Publisher attributionzhaoxinghua09-cellregistry owner unverified by skillvetai
Functional categorySearch, Research & Knowledgeautomatically inferred · 59% rule confidence
Package forminstruction bundle37 recorded files
Canonical sourceClawHub registryclawhub:zhaoxinghua09-cell:medical-device-reg-hub
Open canonical source ↗

Platform declarations

These states come from the source or distribution context. None of the entries below are SkillVetAI compatibility test results.

OpenClawnative officialProvenance: registry distribution

Independent structural checks

These checks parse the fixed package against dated platform rules. They do not execute the Skill or verify task behavior.

Claude Codepasses structure
Checker 0.1.0 · agent-skills-2026-08-13+claude-code-docs-2026-08-13 · 8/27/2026.claude/skills/medical-device-reg-hub

Runtime, accounts, dependencies, permissions, network behavior and task quality remain untested.

OpenAI Codexpasses structure
Checker 0.1.0 · agent-skills-2026-08-13+codex-docs-2026-08-13 · 8/27/2026.agents/skills/medical-device-reg-hub

Runtime, accounts, dependencies, permissions, network behavior and task quality remain untested.

OpenClawpasses structure
Checker 0.1.0 · agent-skills-2026-08-13+openclaw-docs-2026-08-13 · 8/27/2026skills/medical-device-reg-hub

Runtime, accounts, dependencies, permissions, network behavior and task quality remain untested.

Installation and inspection

This command is recorded from the source ecosystem and resolves the registry's latest release. The fixed release shown on this page should be inspected before adoption.

clawhub install @zhaoxinghua09-cell/medical-device-reg-hub
clawhub inspect @zhaoxinghua09-cell/medical-device-reg-hub --version 1.5.0

Security evidence

SkillVetAI static result: high signal

This automated, non-executing scan is bound to this release hash. It is not a safety certification and may contain false positives or false negatives.

Status
completed
Coverage
full text content
Files
35 / 37 inspected as text
Checked
8/27/2026, 10:18:59 PM
Scanner
0.1.3
Policy
1.0.3
1 automated finding
highRemote content is piped directly to a shell安全审计报告.md:29 · confidence 98%curl\|bash
1 High/Critical review queue entry
STATIC_DOWNLOAD_PIPE_TO_SHELLpending
Open human review queue →
2 inferred permission indicators
  • network access — automatically inferred
  • filesystem write — automatically inferred
39 dependency and API indicators
  • api: clawhub.ai
  • api: ec.europa.eu
  • api: english.nmpa.gov.cn
  • api: erps.cmde.org.cn
  • api: eur-lex.europa.eu
  • api: gudid.fda.gov
  • api: health.ec.europa.eu
  • api: maers.adrs.org.cn
  • api: medxpert.cn
  • api: openstd.samr.gov.cn
  • api: regalkes.kemkes.go.id
  • api: std.samr.gov.cn
  • api: udi.nmpa.gov.cn
  • api: webgate.ec.europa.eu
  • api: www.accessdata.fda.gov
  • api: www.argentina.gob.ar
  • api: www.astm.org
  • api: www.cmde.org.cn
  • api: www.cnca.gov.cn
  • api: www.ecfr.gov
  • api: www.fda.gov
  • api: www.gob.mx
  • api: www.gov.br
  • api: www.gov.cn
  • api: www.govinfo.gov
  • api: www.gs1.org
  • api: www.gs1jp.org
  • api: www.iec.ch
  • api: www.imdrf.org
  • api: www.iso.org
  • api: www.kikidb.jp
  • api: www.mhlw.go.jp
  • api: www.nmpa.gov.cn
  • api: www.picscheme.org
  • api: www.pmda.go.jp
  • api: www.samr.gov.cn
  • api: www.std.pmda.go.jp
  • api: www.tga.gov.au
  • api: zwfw.nmpa.gov.cn
External clawhub result: clean

This is registry-supplied evidence for the recorded release, not an independent SkillVetAI scan. Check the canonical source for the full report, scanner versions, scope, and current moderation state.

Evidence checked
8/27/2026, 4:49:14 PM
Release binding
Matches this record
  • vt: clean
  • skillspector: clean
  • llm: clean

Recorded files

The catalog stores hashes and an inventory summary for change detection. It does not republish the package contents.

Package content hashsha256:447f2a599320946672dae299bafea47d1fe978d132c2fe606015962e0faec8dc
Show up to 30 recorded paths
  • assets/overview.svg
  • ATTESTATION.md
  • LICENSE.md
  • manifest.json
  • references/CN_医疗器械委托生产MAH实务.md
  • references/EU_EUDAMED数据库实务.md
  • references/EU_MDR上市后监管PMS实务.md
  • references/FDA_UDI实施实务.md
  • references/FDA创伤敷料供应链穿透检查枢纽.md
  • references/GMP质量体系与验证枢纽.md
  • references/README.md
  • references/UDI全球标识枢纽.md
  • references/上市后监管枢纽.md
  • references/临床评价枢纽.md
  • references/原材料供应商合规枢纽.md
  • references/变更延续管理枢纽.md
  • references/售后服务枢纽.md
  • references/审评核查获证枢纽.md
  • references/市场准入与销售枢纽.md
  • references/技术文件STED撰写枢纽.md
  • references/枢纽总览_全生命周期7阶段纲领.md
  • references/标签与IFU枢纽.md
  • references/注册周期费用有效期对比枢纽.md
  • references/注册工程师资料枢纽.md
  • references/注册检验与申报实操枢纽.md
  • references/灭菌包装验证枢纽.md
  • references/生物相容性测试规划枢纽.md
  • references/设计开发控制枢纽.md
  • references/软件人因枢纽.md
  • references/需求调研与立项枢纽.md

Source changelog

v1.5.0 评测驱动优化：新增常见错误清单（反模式速查12条）、错误处理输入偏离引导、本技能不做5条集中边界声明、frontmatter补title