4 January 2021
Those in the medical device industry will be familiar with the Unique Device Identification (“UDI”) system for medical devices. While it has been a global discussion piece for many years, the timeline for implementation has varied greatly. Most recently, China indicated that they had delayed the full introduction of the UDI system until 1 January 2021. With the new year approaching, it is a good time to revisit the UDI system and the specific background and requirements of the system in China.
Background to the UDI System
The UDI is a global initiative championed by the International Medical Device Regulators Forum (“IMDRF”) that is intended to provide a “single, globally harmonized positive identification” system for medical devices throughout the distribution chain. To facilitate the identification of the medical device, the system requires a “globally unique device identifier” in a standardised format.
The UDI, as discussed in the IMDRF guidance documents, is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows for the unique identification of a specific medical device on the market. The UDI is comprised of Device Identifier (“UDI-DI”) and a Production Identifier (“UDI-PI”), i.e., UDI-DI + UDI-PI = UDI.
The UDI-DI is a fixed element of the UDI and it identifies a manufacturer’s specific product and package configuration. It is also used to identify the specific device in a jurisdictional UDI database. The UDI-PI identifies the unit of device production when one (or more) of the following pieces of data are included on the package label of the device – lot/batch number, serial number, expiration date, manufacturing date, software version, Distinct Identification Code (for human origin products).
For ease of use, the label of most devices will include a UDI in a human readable form and also an automatic identification and data capture (“ADIC”) carrier.
UDI development in China
In China, the nascent elements of a UDI system were proposed in 2012 when the State Council initiated a national level requirement for the unique coding of high-risk medical devices. The State Council followed this requirement by issuing a number of opinions supporting the introduction of the UDI system in China.
On 1 July 2019, the National Medical Products Administration (“NMPA”) issued the “Pilot Work Scheme for Unique Device Identification System” (the “Pilot Work Scheme”), which set out the work objective, pilot scope, responsibility of various parties and the work timelines that would be required to officially implement the UDI system in China.
Following the Pilot Work Scheme, the NMPA published the “Unique Device Identification System Rules” on 23 August 2019 (the “UDI System Rules”), which came into effect on 1 October 2019. The UDI System Rules provide the basic framework for UDI in China.
Based on the UDI System Rules, the NMPA released the “Notice on the Implementation of UDI on the First Batch of Medical Devices (No.72 in 2019)” ( “2019 Notice”), which provided an initial planned implementation date of 1 October 2020 for the UDI system in China. The 2019 Notice also specified the first batch of medical devices subject to the UDI system.
On 29 September 2020, NMPA, National Health Commission and National Healthcare Security Administration co-issued the “Notice on Further Promoting the Pilot Program and Implementation of UDI on the First Batch of Medical Devices (No.106 in 2020)” (the “2020 Notice”). The 2020 Notice postponed the formal implementation date of the UDI system to 1 January 2021 because of COVID-19 and extended the first batch of medical devices compulsory for UDI system into 69 types of devices.
UDI implementation requirements
With implementation of the system being 1 January 2021 (“Implementation Date”), it is important to understand the key requirements for UDI in China according to the 2019 Notice and the 2020 Notice.
Scope of medical devices
As set out initially in the 2019 Notice, and expanded on in the 2020 Notice, the first batch of medical devices subject to the UDI system in China covers 69 specific medical devices. All of these devices are considered “high risk” and are classified as Class III medical devices according to the Medical Device Classification Catalogue. As examples, devices such as heart or brain implants/prostheses are included in the list.
While these 69 device types are required to have a UDI by the Implementation Date, the NMPA is also encouraging manufacturers to voluntarily implement the UDI for other medical devices that do not fall within this initial scope.
Implementation timeline
From the Implementation Date, all medical devices falling within the scope of the initial 69 device types, and manufactured from this date onwards, will be required to possess a UDI marking. Devices within the scope of the 69 device types but manufactured prior to 1 January 2021 will not require such UDI marking.
Submission of UDI information
As the UDI is specifically designed to provide readily accessible information on the medical device, from the Implementation Date, an applicant for product registration, re-registration or change of registration details, must submit the UDI-DI with the application. Prior to putting any product on the market, the registrant must also include the UDI-DI of the minimum size sales unit/pack in the NMPA UDI database.
The UDI database was launched by NMPA on 10 December 2019, and there is detailed guidance on how to submit the required information. Once the information is included in the UDI database, it is the applicant’s responsibility to maintain it and keep it up to date.
UDI System Rules
The legislation that outlines the UDI framework in China is the “UDI System Rules” and they are applicable to medical devices put on the market in mainland China. As stated, a UDI is currently only compulsory for the first batch of medical devices outlined by NMPA; the requirement to apply the UDI to other types of devices will be implemented in phases, but no dates have been announced as yet.
For the implementation of the UDI system, the registrant/filer is required to follow the steps below:
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Select a qualified code issuing agency (currently there are three code issuing agencies: GS1 China, ZIIOT and AliHealth);
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Create the UDI-DI according to the standards of the issuing agency, and determine the information (e.g. expiry date) for the UDI-PI;
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When filing for product registration/recordal or change of registration, submit the UDI-DI;
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Select an appropriate UDI data carrier (e.g. Barcode, QR code and RFID), and assign the UDI data carrier to the minimum sales unit and higher levels of packaging, or the medical device product;
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Submit the UDI-DI and relevant information to the UDI database before the product is put on the market;
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Keep the UDI-DI and relevant information updated on the UDI database.
The UDI-DI information on the UDI database will be accessible to all parties, i.e., the medical device distributor, medical institutions, authorities and the public. The UDI database will allow any party to identify and track a medical device according to its UDI throughout its entire life cycle.
Comments
The UDI system is a long awaited and currently not fully implemented tracking system for medical devices. While it has been discussed for close to a decade in China, it is finally reaching the implementation stage for at least a number of high-risk devices. The delayed 1 January 2021 implementation date for the UDI system will mark the start of what will hopefully translate to the complete listing of all devices over time and provide clinicians, institutions and the general public with greater traceability of medical devices through the healthcare system.
Alison Wong, Partner, Bird & Bird
alison.wong@twobirds.com
