Tag Archive for: udi

China Releases New List of Standards for Medical Device Registration

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The NMPA has released the 2024 revised edition of the “List of Mandatory Standards Applicable to Medical Device Products.

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China’s Third Batch of UDI Implementation Deadline in June

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Reminder that China NMPA’s UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.

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China Fully Implements UDI Requirements for Class 3 Medical Devices

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Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.

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UDI Labelling Mandatory for Certain Taiwan Medical Devices

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In Taiwan, beginning June 1st, 2023, manufacturers of Class II medical devices will need to ensure products placed on the market have compliant Unique Device Identification (UDI) labeling.

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China Continues to Implement UDI of Medical Devices with Third Batch Release

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The NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.

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