Full answers to common questions about the implementation of the unique identification of medical devices (UDI) by enterprises

On July 23, 2020, the General Office of the State Council of China issued the “Key Task of Deepening the Reform of the Medical and Health System in the Second Half Year of 2020”, which clearly required “the implementation of the unique identification of medical devices for key varieties”. Bradynuoen has sorted out and answer the common questions in the implementation process for your reference.

.The enterprise is not in the first batch of pilot enterprises of the CFDA or its main products are not in the list of pilot products， should UDI be implemented?

According to the plan of the CFDA, all medical devices will be covered in recent years.This first batch of pilot work is just the beginning. In the future, it will further promote the orderly and rapid development of related work, not only for a single category of devices.

In the field of UDI, many key domestic enterprises have completed the construction of UDI system first.

For other medical device enterprises, regardless of product category and whether they are pilot enterprises, they should make strategic preparations in advance and fully plan the application of unique identification in enterprise management, product traceability and other fields.

. Is there a deadline for enterprises to implement UDI? When exactly?

According to the requirements of the Notice on Matters Related to the First Batch of Implementation of the Unique Identification of Medical Devices issued by the State Medical Products Administration on October 15, 2019, “starting from October 1, 2020, the production of medical devices listed in the first batch of implementation catalog shall have the unique identification of medical devices”.

For other non-pilot enterprises, there is no specific time required at present, but it is suggested to make strategic preparations in advance to lay a foundation for the full implementation of UDI work in the future.

. How to report the DI part to the CFDA?

A. For enterprises with complete coding team, they can independently register and review in the CFDA and submit DI data.

The CFDA database is open to enterprises for registration, and enterprises need to submit relevant information and forms and accept manual audit.

B.For enterprises without UDI team at present, it is recommended to upload DI data in batches and one-click to the CFDA database for review and declaration through the UDI Declaration Code Assignment Platform.

In addition, the platform can also be compatible with other coding rules, the existing code can be uploaded to the database of the CFDA.

. Can the PI part be self-coded?

According to the current requirements, in the UDI implementation process, the PI part can be coded by the enterprise itself.However, the premise of enterprise self-coding is very familiar with the overall coding rules, and can complete the related work independently.

At the same time, the passability of coding should also be considered. If the passability of coding structure and reading is not enough, some special fields may be unreadable after listing.

. Can the enterprise use Excel sheets to record coded data？

According to the current rules, enterprises keep their own coded data. Therefore, in theory, Excel can be used to record the encoded data. But it is easy to make mistakes by using Excel and other file records.

The UDI Declaration Code Assignment Platform can avoid the above problems. The code generated automatically by the platform can be seamlessly connected with the enterprise’s production ERP system through the API interface to realize the production data circulation.

.The enterprise already has other codes, is it too troublesome to convert to UDI codes?

If enterprise wants to change the code issuing system,it only needs to register the UDI code declaration platform and obtain the UDI code. The platform supports direct reporting to the CFDA and docking with the internal production management system of enterprise. The conversion can be realized on the same day, and the production of enterprise will not be affected by any effect.

In terms of encoding, the encoding system conversion has no effect on the encoding device, and there is no need to replace the encoding device.

In terms of reading, the reading devices on the market are widely supported to scan the QR code.

For more questions on the implementation of UDI, please email: inspirativemed.com