Rules for Unique Identification of Medical Devices

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In: Market Surveilliance, Medicine/medical devices, NMPA
On August 26, the National Medical Products Administration-NMPA issued the Rules for the Unique Identification System of Medical Devices (Unique Device Identification-UDI). There are 18 articles in the Rules, which clarify the purpose, object, principle, responsibilities and relevant requirements of the construction of the unique identification system for medical devices. They have been put into effect since October 1, 2019. The Rules clearly stipulate that the unique identification should be related to the basic features of the product, and in accordance with the principles of uniqueness, stability and scalability. The code-issuing institution shall be a legal person institution within theRead More →

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