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“All-in-One Certificate” ushers Shandong medical devices into the era of universal surgical care kits.

December 19, 2025

  

Breakthrough Progress: From “Multiple Certificates for Different Departments” to “One Certificate

 for Universal Use”.

Traditional single-use nursing kits and surgical kits required separate medical device registration certificates

 for different departments (such as ophthalmology, obstetrics, surgery, etc.) and applications, resulting in 

numerous certificates and complex management. Our company's innovative breakthrough successfully

 integrates multi-department applicable products under a unified technical framework through optimized 

product design, standardized materials, and enhanced clinical validation. This achievement secured a single

 medical device registration certificate covering all departments. This means the same product set can be used

 compliantly across diverse clinical scenarios, marking a leap from “one certificate per department” to “one

 certificate for all departments.”


Industry Significance: Streamlining Processes to Empower Healthcare Efficiency.


Simplified Hospital Procurement and Management: Hospitals no longer need to procure separate products with 

distinct certificates for different departments, reducing inventory pressure and procurement costs while significant

ly improving management efficiency.


Enhanced Clinical Flexibility: Emergency rooms, operating rooms, wards, and other settings can rapidly deploy 

the same compliant product, shortening preparation time—particularly advantageous during urgent care.


Industry Benchmarking: This initiative advances the standardization and consolidation of medical devices, 

establishing a replicable innovative pathway for nationwide registration management of similar products.


manager@qdxinyiyuan.cn

+86 133 1066 6966

+86 133 1066 6966