As in the case of serialization regulations in the pharmaceutical industry, UDI compliance for medical device manufacturers is soon to become a global matter. Following the EU UDI regulations for medical devices and in vitro diagnostic devices, more countries have already issued guidance or a draft of their own localized UDI requirements. Here are just a few examples:
- India requires UDI compliance by January 1, 2022
- China’s UDI requirements are enforced since October 1, 2019
- South Korea’s phased implementation took off in July 2019
- Saudi Arabia has also drafted UDI guidance
- Taiwan’s FDA issued an Administrative Guidance of UDI at the end of 2015
The International Medical Device Regulators Forum (IMDRF) — a voluntary group of medical device regulators from around the world — strives to achieve a high level of standardization of UDI guidelines all over the world. The aim of a standardized UDI system across global markets is to improve numerous aspects of the medical device and healthcare industry by helping fight against the falsification of medical devices, facilitating their traceability and reducing medical errors.
In this respect, back in 2013 IMDRF issued the UDI guidance document, which served as a base for the US and EU UDI regulations. Despite the common efforts toward high levels of standardization, the UDI requirements of some countries differ from those of the EU and the US.
These differences include but are not limited to the following aspects:
- Types of AIDC carriers required (2D Data Matrix or 1D Barcodes)
- How a UDI should appear on the label or package of a device
- What device types are subject to UDI regulations in different markets
- What data attributes are required in UDI-DI and UDI-PI
- Enforcement deadlines
- Events that trigger a new UDI
Manufacturers must stay informed about the regulation amendments in order to be able to react in a timely manner to any regulatory changes and update their packaging strategy if necessary.
Differences in the above-mentioned aspects can have a significant impact on how a UDI system is implemented and used in global markets. This could compel manufacturers to produce inventory that can only be distributed in specific countries or regions.
Manufacturers and packaging companies will need to update their packaging lines to implement solutions that are flexible enough to adapt to the regulations of other countries. In addition, compliance should not come at the cost of the efficiency and speed of the packaging lines. It is, therefore, very important to equip packaging lines with solutions that can maintain high throughput rates.
Wipotec is an international leader in reliable machine solutions that enable compliance with global regulations in the pharmaceutical and medical device industries. Our industry leadership is demonstrated in more than 2000 successful compliance projects.
As a GS1 partner, Wipotec follows global regulatory developments and updates relevant features in its machine solutions to enable full compliance with newly emerging global regulations.