The NMPA issued an inspection result on March 31, 2026 for German manufacturer KARL STORZ’s High-frequency Surgery System.
NMPA organized a remote inspection of KARL STORZ. It was found that the company “has deficiencies in its quality management system regarding product software version control, analysis and handling of adverse events, and performance of the management representative. The products present potential quality and safety risks. The comprehensive assessment concludes that the company does not comply with the requirements of China’s ‘Medical Device Production Quality Management Standard’.”
As a result, the NMPA has decided to suspend the import, distribution, and use of the High-frequency Surgery System with immediate effect.
For other inspection results, please click HERE
China Med Device Cited by RAPS on NMPA Overseas Inspection. Click HERE for the article
Click HERE for the list of devices mentioned in the 2023 National Inspection Plan
How China’s New GMP Overhaul Addresses the Deficiencies Found in KARL STORZ
The suspension of KARL STORZ’s product comes at a critical juncture as China transitions to its revised Good Manufacturing Practice (GMP) for Medical Devices (Announcement No. 107, 2025), which will fully replace the 2014 framework starting November 1, 2026. While the current inspection was conducted under the existing GMP (No. 64, 2014), the deficiencies identified—software version control, adverse event handling, and management representative performance—are precisely the areas that the new GMP elevates into standalone, prescriptive requirements with heightened enforcement expectations.
1. Software Version Control Under the New Validation and Verification Chapter
The 2025 GMP introduces a dedicated Validation and Verification chapter that explicitly requires manufacturers to validate critical production processes and maintain documented evidence of equivalency when changes occur. Software version control falls squarely under this mandate. The new regulation expects manufacturers to:
– Perform revalidation following significant changes in equipment, materials, **software**, or production parameters
– Integrate validation activities into formal lifecycle change management systems
– Maintain audit trails for software modifications, including version history and approval workflows
KARL STORZ’s deficiency in “product software version control” indicates that the company failed to properly manage software iterations, likely lacking documented risk assessments, approval records, or revalidation evidence when software was updated. Under the 2025 GMP, such a lapse would constitute a direct violation of the Validation and Verification chapter, triggering mandatory corrective actions and potential suspension even without a physical inspection.
2. Adverse Event Analysis and Handling Under the New Quality Assurance Chapter
The new Quality Assurance (QA) chapter establishes QA as a core governance function requiring lifecycle risk management supported by continuous data collection, trend analysis, and periodic management review. It also mandates structured change control mechanisms and documented risk assessment for any quality-related decision.
KARL STORZ’s failure in “analysis and handling of adverse events” suggests that the company did not maintain a systematic post-market feedback integration process—a key expectation of the lifecycle management mindset embedded in the 2025 GMP. The revised regulation explicitly requires manufacturers to:
– Establish formal QA systems covering post-market activities
– Use adverse event data to drive risk mitigation and design improvements
– Document complaint investigations and corrective actions with traceable closure
Under the new framework, inadequate adverse event handling would be treated not as an isolated paperwork issue, but as a systemic QA failure that undermines product safety and regulatory compliance.
3. Management Representative Performance Under the New Personnel Qualification Standards
The 2025 GMP introduces more prescriptive qualification standards for key personnel. For Class II and III devices (the KARL STORZ system is a high-frequency surgical device, typically Class III), the regulation requires:
– A qualified management representative with a relevant bachelor’s degree or equivalent technical title and at least three years of experience
– Full-time staffing requirements for legal representatives, management representatives, and quality leads
– Clear separation of production leadership and quality management roles
KARL STORZ’s deficiency in “performance of the management representative” indicates that the individual responsible for ensuring GMP compliance failed to exercise adequate oversight—whether due to lack of authority, insufficient qualifications, or competing operational duties. Under the 2025 GMP, this would be a critical nonconformity, as the management representative is explicitly accountable for quality decision-making and regulatory compliance. The new regulation also reinforces the independence of quality functions from production operations, meaning that any sign of compromised oversight invites immediate regulatory action.
What This Means for Overseas Manufacturers Under the Transition
The KARL STORZ suspension serves as a clear warning that NMPA is actively enforcing QMS compliance—even through remote inspections—and that the upcoming 2025 GMP will impose even stricter requirements in precisely the areas where this manufacturer failed. With the mandatory implementation date of November 1, 2026, overseas manufacturers should:
– Immediately review their software version control procedures against the new Validation and Verification chapter
– Strengthen adverse event analysis workflows to align with the lifecycle-based QA requirements
– Verify that management representatives meet the updated competency thresholds and have clear, independent authority
The one-year grace period is not a pause in enforcement; as seen in the KARL STORZ case, existing GMP rules already prohibit the deficiencies that the new GMP will further codify. Overseas firms that delay upgrades risk facing similar import suspensions, distribution halts, or even facility disqualifications.