Despite frequent and rapid changes in the regulation process, companies cannot ignore the value of bringing medical devices to the Chinese market. It is a potential high-growth area for many global medical device 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 standardized UDI system to strengthen medical device life-cycle management, improve the accuracy of product information and improve patient safety.
The UDI implementation plan by NMPA is in line with US and European UDI guidelines requiring 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 commercialization of the product.
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 pilot program to test its UDI system 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:
- Understand the ‘how’ of M2M data submission process
- Provide feedback to the NMPA with critical test findings
Innovit provides valuable assistance and expertise in helping our customers prepare for UDI submissions to China’s NMPA and machine-to-machine data submissions to NMPA’s UDI database.