The revised China Medical Device Good Manufacturing Practices (GMP), released in November 2025, will take effect on October 1, 2026. Following the release, NMPA has issued comprehensive suite of GMP and GVP (Good Vigilance Practices) documents, moving China’s post-market oversight from a reactive, issue-based approach to a continuous and rigorous audit system.
GMP Inspections in 2026
There was multiple import, distribution, or use suspensions involving prominent foreign manufacturers from Germany, Japan, the United States, and Denmark. These are not mere administrative warnings; they are concrete actions affecting companies:
- Karl Storz (Germany): High-frequency surgical equipment suspended (Issue Date: 2026-01-31).
- Hoya Technosurgical (Japan): Beta-tricalcium phosphate for surgical implants suspended (Issue Date: 2026-07-27).
- Eurocor GmbH (Germany): Paclitaxel-eluting PTA balloon catheter (Issue Date: 2026-08-03).
- Avinger Inc. (USA): Peripheral plaque excision catheters suspended (Issue Date: 2026-08-25).
- Coloplast (Denmark): Foam dressings suspended (Issue Date: 2026-08-11).
- Laurus Optics Limited (UK): Ophthalmic Surgical Blades (Issue Date: 2026-08-27).
The suspensions, effective immediately, follow NMPA’s on‑site or remote inspections, which found that the manufacturers’ quality management systems (QMS) failed to meet China’s current Medical Device Production Quality Management Standard (the 2014 GMP) – the regulation still in force until 31 October 2026.
These enforcement actions come at a critical time, as China is transitioning to a revised GMP that will take full effect on 1 November 2026. Although the current suspensions are based on the existing 2014 framework, the deficiencies identified – ranging from documentation and design control to quality assurance and batch release – are precisely the areas where the new GMP introduces more prescriptive, standalone requirements with heightened compliance expectations. The August cases serve as an early warning for overseas manufacturers.
Inspection Guideline
To standardize the inspections, NMPA released a draft inspection guideline on June 9, 2026. This guideline applies to manufacturing license inspections (including changes and renewals) and all post‑market surveillance inspections for registrants and contract manufacturers. It translates the GMP into 200 inspection items grouped by risks, among them 39 items are marked as critical. They encompass quality system responsibility, resource adequacy, change control, design transfer, supplier and process controls, inspection procedures, product release, and contract manufacturing oversight, forming the core of inspection readiness.
Inspection decisions vary: for license inspections, outcomes are Pass, Fail, or Rectify and re‑inspect; for surveillance, outcomes are Self‑rectification, Suspend production, or Rectify within deadline. Fail or suspension results from fraud, more than 2 critical non‑conformities, 10 or more critical+major non‑conformities, or total deficiencies over 20. Enhanced risk considerations include systemic inter‑related issues, repeated deviations, and deception, which may escalate actions.
GVP Guidelines
Complementing the GMP enforcement is the comprehensive GVP framework. In April 2026, the NMPA issued seven critical guidelines through the Center for Drug Reevaluation (CDR). These documents create a detailed blueprint for a robust post-market vigilance system. They include:
- Guidelines for Medical Device Adverse Event Risk Evaluation (2026 Revision)
- Guidelines for the Review of Periodic Risk Evaluation Reports (Trial)
- Medical Device Vigilance Quality Management Standards (Trial)
- Guidelines for Preparing Periodic Safety Update Reports (PSURs) (Trial)
- Guidelines for Preparing Trend Reports (Trial)
- Key Points for Medical Device Vigilance Inspections (Trial)
- Guidelines for Drafting Vigilance Plans (Trial)
The documents indicate that NMPA expects manufacturers to operate a fully functional vigilance system. This is not about simply filing an occasional adverse event report; it requires systematic signal detection, trend analysis, periodic reporting, and a demonstrable connection between vigilance findings and risk management actions.
Annual AE Report
The scale and operational reality of this vigilance system are illustrated by the 2025 annual adverse event report released in July 2026. The national system received over 1 million adverse event reports in 2025, a 5.7% increase from the prior year, representing 709 reports per million population. Notably, 8.53% of these reports involved serious injury or death, underscoring the critical need for effective risk evaluation. By device class, Class III high‑risk devices contributed 41.12% of all reports, while Class II moderate‑risk devices accounted for 50.72%, meaning that over 90% of adverse events are associated with moderate‑ to high‑risk products. Medical institutions submitted nearly 90% of reports, yet registrants (manufacturers) submitted less than 4%, revealing a potential gap in direct manufacturer engagement in China’s vigilance process. The top reported product categories include infusion instruments, clinical laboratory reagents, and physiotherapy equipment.
With over 447,000 registered users in the monitoring network, the infrastructure for vigilance is extensive and active. Foreign manufacturers cannot afford to treat GVP as a passive obligation; they must build systems capable of handling case intake, trend analysis, and periodic reporting to meet NMPA’s expectations.
Navigating Manufacturing and Inspection Readiness for Foreign Manufacturers
Our analysis of the new GMP framework and recent enforcement actions reveals a critical need for foreign manufacturers to re-evaluate their entire China quality strategy and perform gap assessment about the alignment of global quality system and China quality system requirements and local practices. The past having distributors and sales operations handing vigilance will not meet the new requirements. The new regulation requires that the foreign legal manufacturer, its China agent, contract manufacturers, critical suppliers, and importers operate as one cohesive, inspection-ready system.
We offer a service that addresses this systemic need. This begins with a China GMP Applicability and Gap Assessment. Many global QMS are robust but may not fully address the nuances of the NMPA’s GMP requirements, particularly for sterile devices, implantables, and outsourced manufacturing. Our service maps the manufacturer’s global QMS against the specific requirements, identifying gaps in critical areas such as supplier control, special process validation, traceability, and design transfer. This assessment clearly delineates responsibilities between the headquarters, the China agent, and any contract manufacturers.
The next crucial service is Foreign Inspection Readiness. A foreign manufacturer must be prepared for an unannounced or planned NMPA inspection. Our program provides mock NMPA inspections designed to be more rigorous than the real thing. This includes document room preparation, bilingual interview training for both global and China-based personnel, and creating an inspection evidence index that allows for rapid retrieval of any requested document. The goal is to transform a potentially chaotic experience into a structured, controlled process.
A unique and high-value offering is Product Sampling and Technical Compliance. The NMPA publishes a Annual National Medical Device Inspection Plan and reports on the results of its sampling activities. Our service predicts which product families are most likely to be sampled and conducts a pre-sampling review to ensure that the devices in the Chinese market remain fully aligned with the registered technical requirements and specifications. This proactive approach is far more effective than reacting to a failed sample result, which can lead to recall and import suspension.
Our key deliverables for the GMP pillar include:
– China GMP Gap Assessment Report
– Inspection Readiness Scorecard & Playbook
– CAPA Remediation Plan
– China Quality Responsibility & Supplier Control Matrix
– Mock Inspection Report
Building a Comprehensive Vigilance System with New GVP Systems for Foreign Manufacturers
The April 2026 GVP documents provide a more systematic framework for post-market vigilance. The approach should be holistic, covering everything from system setup to ongoing operations.
Our service begins with China Vigilance System Setup. This involves performing gap assessment and establishing a China Medical Device Vigilance Plan and a comprehensive SOP package. A critical element is defining a clear roles and responsibility matrix that establishes formal interfaces between the headquarters and your China legal representative.
The core operational service is Adverse Event Case Management. This is more than translation. It involves a systematic aligned quality process for intake of complaints from hospitals, patients, and distributors; medical coding; a robust reportability assessment; and timely submission of initial and follow-up reports in Chinese. Crucially, this process must be reconciled with the manufacturer’s global database to ensure consistency in safety reporting worldwide. The past model of relying on distributors and sales office operations are no longer sufficient to meet the new requirements.
The most value-added aspect of a GVP service is Periodic Reporting and Signal Management. The 2026 guidelines emphasize the requirement for Periodic Safety Update Reports (PSURs) and Periodic Risk Evaluation Reports. Our service prepares these reports by aggregating global and China-specific safety data, calculating complaint and event rates, and summarizing CAPAs and field actions. Furthermore, we establish a proactive signal management system that sets trend thresholds, monitors complaint rates, and identifies potential safety signals based on severity and failure mode trending. By connecting adverse events to risk management and CAPA, the system provides a clear feedback loop that is essential for product safety and continuous improvement.
GVP Inspection Readiness is also a critical part. A mock vigilance inspection will test the entire system, tracing a case file from complaint intake through risk assessment to ensure full traceability and data integrity and alignment with global quality system. This ensures that whether the NMPA performs inspection on local China operations through your distributor, local legal agent or sales office or outside of China, the manufacturer can demonstrate a fully functional and controlled vigilance system.
Our key deliverables for the GVP pillar include:
– China Vigilance System Master File & Vigilance Plan
– Complete China GVP SOP Package
– Signal Detection Methodology & Trend Report Template
– PSUR/PRER
We help you protect your China market access through proactive inspection readiness, adverse event and signal management, periodic safety reporting, and product sampling readiness, etc. Contact us at info@ChinaMedDevice.com.