Home About Qualtech NEWS CHINA: Pilot Implementation for Medical Device UDI System to be Conducted on Selected High-risk Consumables – August 2019
CHINA: Pilot Implementation for Medical Device UDI System to be Conducted on Selected High-risk Consumables – August 2019

August 13, 2019

In July, China government had issued the “Pilot Plan of the Unique Identification System for Medical Devices”, which implies subsequent trial implementation of unique identification system for medical devices in China. 

The high volume of information cumulatively kept by hospitals each year indicates a pressing need for an efficient management system of hospital consumables – hence a bar code recognition placed on product packaging has been thought to reduce the burden.

The UDI system strengthens national surveillance system for the medical device all throughout its life cycle by assigning specific codes that aids one to determine how a device is produced, used and distributed. 

Pilot implementation shall be carried out on selected medical registrants, operating companies and hospitals handling high-risk implantable devices (e.g. heart and brain implants and prostheses). The pilot implementation plan also describes the duties and responsibilities of medical device registrants, operating companies, hospitals, coding agencies, industrial organizations and health departments.

The outcome of the said trial shall determine NMPA’s strategy to upscale its implementation nationwide, while including other types of medical devices within the scope.

  

Reference:

Official press

The notification of pilot work

 

Tags:

UDI system, High risk consumable, Post Market

 

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Home About Qualtech NEWS CHINA: Pilot Implementation for Medical Device UDI System to be Conducted on Selected High-risk Consumables – August 2019