gmp2025-transition

中国《医疗器械生产质量管理规范》2025 版（国家药监局 2025 年第 107 号公告，2026-11-01 施行）过渡时间线、倒计时与企业自查行动清单。

凡自治之物 · LGD 治理学 · 创造术家族 ｜ 评测协议：见平台质量门禁规范

English

GMP 2025 Transition Assistant

Given a reference date, compute days remaining to the 2026-11-01 effective date, the current phase, and recommended actions for China's medical-device GMP 2025.

Verified fact baseline

Item	Content
Announcement	NMPA Announcement No.107 of 2025
Effective	2026-11-01
Replaces	2014 version (Announcement No.64 of 2014) after effective date
Structure	15 chapters, 132 articles; adds chapters on quality assurance, validation & verification, and contract manufacturing/outsource processing
Data frozen	2026-09-21 (multi-source cross-check)

Usage

bash

python scripts/gmp_transition.py status                     # current phase & countdown
python scripts/gmp_transition.py timeline                   # national + provincial timeline
python scripts/gmp_transition.py checklist                  # 12-item self-inspection
python scripts/gmp_transition.py sources                    # data sources
python scripts/gmp_transition.py status --json

Days to effective	Phase	Advice
> 180	Preparation	gap analysis, training, document revision schedule
91–180	Self-inspection rectification	close gaps, schedule internal audits & training records
≤ 90	Sprint	system version upgrade, internal audit, management review, timely filing
< 0	In effect	run under new rules, follow up on nonconformities

Boundary

Outputs timing and action prompts only; does NOT judge compliance or replace official interpretation. Provincial deadlines are examples; follow local NMPA notices. Medical-device compliance must be reviewed by qualified personnel.

Requirements

Python 3.8+, zero third-party deps.

Evidence & safety

• Evidence: TBD; Version: 1.0.1; Security: no independent scan (TBD).

中文

gmp2025-transition

中国《医疗器械生产质量管理规范》2025 版过渡助手。给定基准日期，算出距施行还有多少天、处于哪个阶段、该做什么。

已核验的事实基线

项	内容
公告	国家药监局 2025 年第 107 号公告
施行日	2026-11-01
替代关系	施行后替代 2014 年版
新版结构	共 15 章 132 条；新增质量保证、验证与确认、委托生产与外协加工三章
数据核定	2026-09-21

使用方法

bash

python scripts/gmp_transition.py status        # 当前阶段与倒计时
python scripts/gmp_transition.py timeline      # 过渡时间线
python scripts/gmp_transition.py checklist     # 12 项自查行动清单
python scripts/gmp_transition.py sources       # 数据来源

阶段划分：>180 天准备期 / 91–180 天自查整改期 / ≤90 天冲刺期 / <0 已施行。

边界声明

只输出时间与行动提示，不判定是否符合《规范》，不替代官方解读；省级时限为示例，以属地药监局为准；合规判断须由具备资质人员复核。

环境要求

Python 3.8+，零第三方依赖。

证据与安全声明

• 证据：TBD；版本：1.0.1；安全：未做独立扫描（TBD）。