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Who this guide is for
Manufacturers in China placing devices on the EU market, European authorised representatives working with Chinese factories, and Chinese groups that acquired EU labels but left quality systems split across borders.
Certification & notified body bottlenecks
- Class shifts that require new conformity assessment routes.
- Clinical evaluation reports that recycle pre-MDR literature without device-specific evidence.
- Supplier and critical-component changes not reflected in the technical file.
- IVD reclassification under IVDR catching legacy “self-cert” habits.
Post-market surveillance & FSCA
PMS plans must produce real signals—not annual PDFs. When serious incidents arise, field safety corrective actions (FSCA) and field safety notices need coordinated EU and China communication. Misaligned Chinese recall language vs EU FSCA text creates product-liability exhibits (see device liability and recalls).
“强制下架” style risk narratives
Market withdrawal, sales suspension, or certificate suspension/revocation can follow non-conformities, missing vigilance, or failed audits. Distributors may stop orders before regulators finish. Contract for: who pays stock write-offs, who notifies competent authorities, and how long the manufacturer must support legacy installed base.
China factory + EU label operating model
- Clear PRRC / person-responsible mapping and EU AR agreements with audit rights.
- Change control that freezes EU SKUs when China plants “optimise” processes.
- Bilingual complaint intake that feeds both NMPA vigilance and EU PMS.
- UDI and EUDAMED registration ownership—no orphan devices after staff turnover.
Parallel US path
Groups selling into both US and EU should not run disconnected CAPA universes. FDA letters and MDR audit findings often share root causes—coordinate with FDA Warning Letter playbook.
Related
China distribution (inbound) · China device licensing · Hub
FAQ · 高频检索问题
Chinese long-tail intents mapped to this guide (orientation only).
欧洲 MDR/IVDR 证书过期会怎样？
中国工厂改工艺是否必须通知欧盟？
FSCA 与中国召回如何协同？
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