China’s New GMP 2025 – What Every Global Manufacturer Must Prepare Before Nov 1, 2026

China’s new Good Manufacturing Practice for Medical Devices (GMP No.107‑2025) represents the most significant overhaul of China’s medical device quality system requirements in the past decade. The new regulation, officially released in November 2025 and taking effect November 1, 2026, fully replaces the 2014 GMP and expands regulatory expectations across the entire product lifecycle—from R&D to production, outsourcing, quality assurance, and post‑market activities.

This webinar provides a clear, structured, and practical overview of the 2025 GMP, highlighting what has fundamentally changed compared with the 2014 version. impacts on registration inspection, foreign inspection, legal agent responsibility and post market reporting and compliance, and a lot more. In the end, we will cover key understanding of China GB/YY standards.

Participants will gain:

A clear understanding of what changed from 2014 → 2025

A chapter‑by‑chapter breakdown of new requirements

Key actions needed before November 1, 2026

Practical compliance strategies for MAH, registrants, filers, and contract manufacturers

Insights into foreign inspection trends and how to prepare

Updates on how evolving GB/YY standards & PTR impact type testing and registrations

Attached Files

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