For those regulatory professionals who thought the UDI quagmire was sorted, have you thought about the unique identification requirements as legislated by Peoples Republic of China via the NMPA? On 10 August 2020 the NMPA launched Unique Device Identification (UDI) Database on its website.

  • From 01 January 2021 (43 days from blog posting date)
    • the first group of 64 Class III medical devices shall have unique identifiers
Please be aware, even though only 50 data attributes are necessary for submission to the China UDID database, less than US FDA and significantly less than under MDR, 30% of these attributes are UNIQUE for China UDI. Thus, yet another set of regulatory data to capture and maintain.

It really took a bit of trolling through the internet to finally find a complete list (in English) of the 64 devices assigned for the first phase of UDI implementation (It would appear that access to English translations of the 64 product names are carefully shrouded in unobtainability ):

The Chinese medical device and in vitro diagnostic market is growing substantially. When conceiving and articulating your global regulatory strategy, the requirements for global UDI demand to be at the forefront for accurate decision making. Regulatory professionals, ensure that senior management understands your operational workflow constraints and prerequisites for capturing, maintaining, accessing, amending and transmitting global UDI data necessary for maintaining compliance and therefore marketability. Compliance translates into revenue and patient satisfaction.

As always, please refer to the original NMPA data sources for confirmation of requirements as translations may be inaccurate.

KimYoung@instem.com

K Young

REFERENCES:

National Medical Products Administration (NPMA)

NMPA UDID CIC Message Mapping-Aug2020-v1.0-en

NMPA UDID to GDSN Attribute Mapping 20200609 v1.5

Quick Guide for NMPA UDID GDSN Testing-Sep2020-v1.1-en

https://udi.nmpa.gov.cn/

GSI China: http://gmd.gds.org.cn:8080/index.php?doc-view-43601

China Medical Device https://chinameddevice.com/udi-nmpa/

Photo by Kayla Kozlowski on Unsplash