NMPA had issued rules for Medical Device identification under Order 66, released in October 2019, which states that medical devices marketed in China shall comply with UDI regulations and implementation plan.
What is included in Device Identification?
The UDI implementation plan by NMPA is in line with US and European UDI guidelines that require a unique identifier for each device including the Device Identifier (DI) and Production Identifier (PI). The DI is used for identification of device in UDI database that identifies the manufacturer, device’s specification, model and packaging. The PI includes batch code, expiry/manufacturing date that identified variable information in device manufacturing to track and control the batch in supply chain. The UDI codes need to printed on devices, primary and secondary packaging that shall be compliant for Automatic Identification and Data Capture (AIDC) and Human Readable Interpretation (HRI).
Who is responsible for submission of UDI data to NMPA?
In China, local agent for device importers or manufacturers are responsible for submission of UDI data with NMPA and maintain it on annual basis. Any change in the device identification (UDID), must be reported within 30 days.
Who is the UDI issuing agency in China?
Currently, GS1 China is the only UDI issuing agency that guide’s device manufacturers and issuance and implementation of UDI in China. Other issuing agencies to be assigned.
How Does UDI Impact Medical Device Labeling and Packaging?
The UDI number shall be printed on both the device unit and all packaging (primary and secondary). UDI number is additional labeling requirement apart from existing local labeling requirements in China. Medical Device manufacturers must plan their batches to include UDI in upcoming batches for their devices as per the NMPA implementation plan.
What are the Implementation Timelines?
NMPA has released products lists as part of phased implementation plan. For certain product lists, the implementation of UDI could be earlier the European Union. First set of products need to have UDI label implemented on them by August 2020 followed by other set of devices.
POWERPOINT PRESENTATION: UDI.https://globalregulatorypartners.com/wp-content/uploads/2018/04/UDI.pdf
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