Although the regulatory process can be challenging due to rapid changes, bringing medical devices to the Chinese market is a potential high-growth area for many global manufacturers.  So, if you’re a medical device manufacturer doing business in China, it’s important that you’re up‑to‑date on the following UDI regulation.

China’s National Medical Products Administration (NMPA) is implementing an electronic medical device registration system and has provided Unique Device Identification (UDI) system rules that are applicable to all device classes.  These rules are intended to support the creation of a standardised UDI system to strengthen medical device lifecycle management, improve the accuracy of information about products and ultimately improve patient safety.

Regulation Details

The UDI implementation plan by NMPA is in line with US and European UDI guidelines that require a unique identification code for each device including the Device Identifier (DI) and the Production Identification (PI).

DI is the unique code identifying the license holder, the model and the packaging information of the medical device; PI is composed of codes related to the production process such as serial number, batch number, production date and expiration date.

The DI and related data must be uploaded to the Medical Unique Device Identification Database (MUDID) within 60 days after the product is approved or renewed, and before the commercialisation of the product.

Deadlines

The deadline to submit UDI data for 64 categories of high-risk implantable devices as stipulated in Schedule 1 of NMPA’s plan is October 1, 2020.

However, on 14 September 2020, GS1 China announced that the NMPA has suspended testing of their MUDID system without providing clear timelines for when this key activity will be resumed.  At this stage, we can only assume that the first phase of compliance will be delayed until further notice.  We will provide updates as more information becomes available.

Innovit and GS1

The NMPA began a pilot program to test its UDI system which was completed in June 2020.  Currently, Innovit is collaborating with GS1 China and key customers (such as 3M and Arthrex) to conduct machine‑to‑machine (M2M) testing with two goals in mind:

  1. Understand the ‘how’ of M2M data submission process
  2. Provide feedback to the NMPA of critical test findings.

Innovit provides valuable assistance and expertise in helping our customers prepare for UDI submissions to China’s NMPA as well as participate in the machine-to-machine data submissions to NMPA’s UDI database.