medical-device-reg-hub

凡自治之物 · LGD 治理学 · 创造术家族 ｜ 评测协议：skill-quality-gate

English

What this is

A structured knowledge hub for medical-device registration engineers. It consolidates regulations, standards, submission systems and templates from NMPA / FDA / EU MDR / PMDA and other markets into clickable official sources, organized by market × stage × product category. Covers the full flow: feasibility → classification & pathway → technical file → QMS → submission → review → post-market.

It ships 8+ topic hubs plus a global index and multi-market classification evidence: main index, UDI, STED writing, cycle-cost comparison, supplier compliance, GMP/validation, ISO 14971 risk, clinical evaluation, sterilization packaging, registration testing & submission practice, change/renewal, software/HF/IEC 62304, market access/sales, requirements & feasibility, design controls, after-sales, biocompatibility planning, post-market surveillance, labeling & IFU, and a 13-market real-certification classification evidence file for arthroscopic/basket/grasper forceps.

Why this hub

• Conclusions are grounded in real registration certificates, not guesses; boundary cases are flagged "to verify".
• Every point links directly to NMPA / FDA / EU MDR / PMDA / other official pages; conclusions are traceable.
• Covers CN / US / EU / JP plus ASEAN & LATAM; 13-market comparison included.
• 119 official links browser-verified on 2026-08-14; near-zero dead-link rate.
• Maintained by a front-line medical-device international-registration practitioner.

Triggers

"medical device registration", "NMPA", "FDA 510(k)", "PMA", "De Novo", "MDR", "CE", "IVDR", "PMDA", "JMDN", "UDI", "STED", "eSTAR", "eRPS", "ISO 10993", "ISO 13485", "post-market", "IFU", "supplier compliance", "registration cycle/cost", or classification questions for specific products.

Workflow

1. Determine intent: product classification / topic deep-dive / cross-market comparison.
2. Load the most relevant references/ file (see navigation table) — never invent clauses or links from memory.
3. Answer with the conclusion plus the official direct link.
4. If the user wants a deliverable, generate Markdown / HTML comparison tables from references.
5. Flag timeliness: key data points must be checked against the latest official release; unverified items marked "to verify".

Key facts (avoid common misjudgments)

• CN: Class I = municipal filing; Class II = provincial registration; Class III = NMPA central. Reusable arthroscopic forceps usually Class II (provincial); open/non-sterile plain forceps Class I.
• US FDA: 21 CFR 888.1100(b)(2) product code HRX — basic reusable manual arthroscopic forceps/graspers are Class I, 510(k)-exempt; only variants with special function / sterile single-use / advanced claims are Class II 510(k).
• EU MDR: reusable surgical instruments per Rule 6 are usually Class I (self-declaration + CE); sterile/measuring/software variants need a Notified Body.
• JP PMDA: structure classes (general I / controlled II / highly controlled III·IV) are correct; "most reusable manual arthroscopic forceps are Class I" is inference — verify by JMDN code (e.g. 361030) on PMDA; flagged to-verify.
• ASEAN/LATAM: bands are correct (Thai FDA lists reusable surgical instruments as Class 1 = ASEAN class A); country details vary.

Boundary

• This is a curated index of public official information; it is NOT a regulatory opinion.
• Classification of boundary products should go through official classification-determination procedures.
• Do not fabricate clauses or links; always cite references.

Evidence & safety

• Evidence: TBD. Version: 1.1.1. Security: see package security snapshot; no independent external scan.

中文

这是什么

医疗器械注册工程师的结构化资料枢纽。把分散在 NMPA / FDA / EU MDR / PMDA 及各市场官网的法规、标准、申报系统、模板，按「市场 × 注册阶段 × 产品类别」整理成可点击直达的官方源。覆盖从产品立项 → 分类与路径 → 技术文件 → 质量体系 → 注册申报 → 审评获批 → 上市后的全流程。

内置 8 大专题枢纽 + 1 份全球注册索引 + 1 份多市场分类实证：主索引、UDI、STED 撰写、周期费用对比、供应商合规、GMP 质量体系与验证、ISO 14971 风险管理、临床评价、灭菌包装验证、注册检验与申报实操、变更延续管理、软件人因（IEC 62304 / SaMD / 网络安全）、市场准入与销售、需求调研与立项、设计开发控制、售后服务、生物相容性规划、上市后监管、标签与 IFU，以及篮钳/剪线钳/过线钳 13 市场真实注册证验证的分类实证。

为什么用这个枢纽

• 不是泛泛而谈，是「真实注册证验证过」的结论：不做拍脑袋推断；边界情形明确标注"待核验 / 走分类界定"。
• 官方源一站直达：每个要点都附带 NMPA / FDA / EU MDR / PMDA / 各国官网直达链接，结论可溯源、可复核。
• 覆盖中 / 美 / 欧 / 日 + 东南亚·拉美：从单一市场到 13 国横向对比都有。
• 链接已逐条核验：references 内 119 条官方链接于 2026-08-14 经浏览器级复核，死链率趋近于零。
• 作者即从业者：由医疗器械国际业务一线（熟悉 GMP / NMPA 法规、海外报证）整理维护。

触发场景

当用户提到以下任意内容时，优先加载本技能并从 references/ 调取对应资料：

• "医疗器械注册" / "医械注册" / "注册工程师"
• "NMPA" / "FDA 510(k)" / "PMA" / "De Novo" / "MDR" / "CE" / "IVDR" / "PMDA" / "JMDN"
• "UDI" / "唯一标识" / "发码机构"
• "STED" / "技术文件" / "注册资料" / "eSTAR" / "eRPS"
• "生物相容性" / "ISO 10993" / "GB/T 16886"
• "GMP" / "ISO 13485" / "QSR" / "QMSR" / "工艺验证" / "再处理验证"
• "上市后" / "不良事件" / "召回" / "PMS" / "FSCA"
• "标签" / "IFU" / "说明书"
• "供应商合规" / "13485 证书" / "材质证明"
• "注册周期" / "注册费用" / "证书有效期" / "注册路径"
• "全球注册" / "中国/美国/欧盟/日本/东南亚/拉美 注册"
• 具体产品如"关节镜钳" / "腔镜器械" / "取石网篮" 的注册分类与路径问题

使用流程

1. 判断意图：某产品的分类/路径、某专题要点、还是跨市场对比？
2. 加载对应资料：从 references/ 读取最相关的文件，不凭记忆编造法规条文或链接。
3. 给结论 + 官方源：每个结论附 references 中的官方直达链接。
4. 生成交付物：若用户要"做成资料/网页/清单"，基于 references 内容生成 HTML / Markdown 交付物。
5. 标注时效与边界：法规/标准会更新，关键数据提示以官方最新发布为准；未逐码验证条目标"待核验"。

references/ 文件导航

关键事实速查

• 中国：境内Ⅰ类市局备案，Ⅱ类省局注册，Ⅲ类国家局；进口Ⅱ/Ⅲ类国家局。关节镜用钳（腔镜、无菌）多归 Ⅱ类（省局）；开放/非无菌普通钳归 Ⅰ类（市局备案）。
• 美国 FDA：21 CFR 888.1100(b)(2)（产品代码 HRX）将基础手动复用型关节镜 forceps/graspers/suture passers 列为 Class I、豁免 510(k)；仅带特殊功能/无菌一次性/进阶宣称的变体才归 Class II 510(k)。
• 欧盟 MDR：可重复使用外科器械按 Rule 6 多归 Class I（自我声明 + CE）；无菌/测量/带软件等才需公告机构介入。
• 日本 PMDA：结构（一般Ⅰ/管理Ⅱ/高度管理Ⅲ·Ⅳ）正确，但"多数复用手动关节镜钳为 I 类"系推断，须按具体 JMDN 编码在 PMDA 查实，标注 ⚠️ 待核验。
• 东南亚/拉美：区间正确（泰国 Thai FDA 明确"可重复使用手术器械"= Class 1 = ASEAN A 类）；具体国家略有差异，以各国官网为准。
• 官方链接有效性：FDA/ISO 站点 bot 探测常返 404/403（反爬），但浏览器可正常打开；判定链接是否有效必须以浏览器级核验为准。

能力边界

• 不替代法律/监管意见：本技能汇总公开法规要点与官方源索引，正式合规决策以官方最新发布与专业顾问为准。
• 时效声明：法规/标准会更新，关键数据以官方最新版本为准；对未逐码核验的条目明确标注"待核验"。
• 不编造：结论附 references 中的官方直达链接，不凭记忆编造法规条文或链接。

证据与安全声明

• 证据：见包内 ATTESTATION.md、manifest.json 与 security_results.json（2026-10-16 读取）。
• 版本：1.1.1
• 安全：本地闭环 / 零凭据 / 去敏扫描 / 版权三件套 / 权属五件套 / 文档一致性 / 结构完整 / 可重跑性 8 项均 5 分，sensitive_hits=[]；另见包内 ATTESTATION.md。