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Global Medical Device Company GSP-Compliant Storage Case
Case Study

Global Medical Device Company GSP-Compliant Storage Case

GSP-compliant warehousing powering compliant, efficient imported medical device operations in China.

Medical Devices

business_center Overview

Client Background

China subsidiary of a global top-10 medical device company, specializing in IVD reagents, surgical instruments and implants with 100+ NMPA registrations covering nationwide Grade-A hospitals and independent labs.

Challenge

China's updated GSP imposes stricter temperature monitoring records and traceability for medical device storage; large volumes of imported products require proper storage before registration completion; multiple temperature tiers (ambient/temp-controlled/refrigerated) require segregated zones with unbroken monitoring.

Results

200K+ units

Annual Volume

100%

Audit Pass Rate

24/7

Temp Data Monitoring

Integrated Yunxiu Solution

End-to-end smart warehousing tailored to your industry's requirements for environment, speed and accuracy.

monitoring

GSP-Compliant Storage System

18-25℃ temperature-controlled zone with 24/7 sensor coverage, auto data logging with 5+ year retention for NMPA and customs audit.

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Multi-Zone Temperature Management

WMS 2.0 supports ambient, temp-controlled and refrigerated zone segregation with automatic temperature tier validation at inbound and outbound.

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Full-Chain Traceability & Audit Reports

End-to-end temperature data logging for every product from receiving to dispatch, with batch/registration/expiry-based audit compliance reports.

Step 01

Credential Review & Registration Management

Systematized management of 100+ NMPA registration certificates with expiry, supervision category and temperature tier requirements, auto-expiry alerts.

100+Registrations managed
Step 02

Temperature-Controlled Receiving & Putaway

Transport temperature records verified on arrival, piece-by-piece barcode scanning into temp-controlled zone, WMS auto-assigns location and activates monitoring.

Step 03

Inventory Management & Expiry Alerts

Real-time batch expiry tracking with 90/60/30-day three-tier alerts preventing expiry waste and loss.

Step 04

Compliant Outbound & Distribution

Order-based picking with complete temperature traceability reports accompanying goods, supporting cold-chain dedicated trucks or insulated packaging delivery.

Detailed Data

Project Background

The client, a global top-10 medical device company, holds 100+ NMPA registrations across IVD, surgical and implant categories. As China tightens medical device regulation, the updated GSP imposes higher warehousing requirements.

Yunxiu Solution

  • GSP Temp-Controlled: 18-25℃ ±2℃, sensors every 5 minutes, 5+ year cloud storage
  • Multi-Zone WMS: System-level temperature validation, correct zone auto-assignment
  • Registration Library: Digital management of every certificate's expiry and linked SKUs
  • Audit-Ready: Generate compliance reports covering full inbound→storage→outbound chain on demand

Results

18 months of stable operation, 300,000+ units handled, zero GSP compliance incidents, zero inspection findings.

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Yunxiu's GSP-compliant storage system lets us handle NMPA unannounced inspections with confidence. Every audit, we can instantly produce complete temperature records and inventory traceability data — something impossible with our previous self-operated warehouse.

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