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Enabling Medical Devices to Speak 'International Language': China Launches Pilot Program for Unique Device Identification System
Release time:
2025-03-12 09:43
Xinhua News Agency, Beijing7month3Daily News(Reporter Li Yanan)China National Medical Products Administration3The China National Medical Products Administration (NMPA) announced on that the pilot program for China's unique identification system for medical devices has officially begun, marking a significant step forward in making China's medical device supervision system more scientific, legalized, internationalized, and modernized.
Unique Identification for Medical Devices(UDI)is the“identification card”of medical devices“international language”Establishing a unique identification system and strengthening the source coding will help to achieve full chain traceability of medical devices through unique identification, strengthening the management of the entire life cycle of medical devices.
Reference image: Medical device exhibition. Xinhua News Agency reporter Futian Photographed
The "Pilot Program for the Unique Identification System for Medical Devices", recently jointly issued by the Comprehensive Department of the NMPA and the Office of the National Health Commission, clarifies that the first batch of pilot programs will focus on high-risk implantable medical devices such as cardiac, craniocerebral implants, and prostheses.(medium)implantable
The NMPA pointed out that the joint pilot program by the two departments will help to create a full-chain linkage from the source production to clinical use, achieve data sharing, and promote the linkage of medical treatment, medical insurance, and pharmaceuticals.“Three Medical Linkages”。
As an internationally accepted practice, many countries and regions around the world are actively promoting the construction of unique identification systems for medical devices. In China, the industry has been calling for this for many years. Establishing a unique identification system for medical devices can achieve transparency and visualization in all aspects of production, operation, and use, improving product traceability. This will play a positive role in purifying the market, optimizing the business environment, improving the quality of medical services, and assisting the transformation, upgrading and healthy development of the medical device industry.(Complete)
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