Medical device manufacturers worldwide are striving for a system of Unique Device Identification (UDI) within the next five years under the ongoing global flux. As a member of IMDRF, China is actively keeping pace with this international harmonization to enhance patient safety, facilitate adverse event traceability and reporting, and improve surveillance throughout products’ whole life cycle.
On 1st July 2019, NMPA and the National Health Commission jointly issued Unique Device Identification (UDI) System Pilot Scheme (order 56). This scheme sets out work objectives, the scope of the pilot products, responsible stakeholders, schedules, and safeguard measures. In the following month, NMPA officially released Unique Identification System Rules for Medical Devices (Order 66). Order 66, effective from 1st October, states that medical devices sold and used in China shall comply with laid-out UDI implementation rules. It also defines the responsibilities and tasks of medical device registrants, manufacturers, code issuing entities and authorities.
Sharing lots of similarities of international practices, China UDI means a unique, alphanumeric code, which consists of two parts: DI and PI. DI (Device Identifier) is a unique fixed code specific to manufacturer, model/specification and packing of a device. It is also the identifier used to access the UDI Database (UDID). PI (Production Identifier) is a variable code related to control mechanisms used in production of the device. Common PIs are lot/batch number, expiry date, manufacturing date and serial number. PI may vary based on device type and manufacturer’s practice. UDI is represented in both AIDC (Automatic Identification and Data Capture) and HRI (Human Readable Interpretation) format. China UDI carrier and assignment are following the international standards too.
UDI shall be properly entered when applying for product registration, amendment or filing in the medical devices ERPS registration system after the implantation date. The smallest sale’s unit label shall bear UDI upon registration application, and UDI is also required to be uploaded to the dedicated database before the product is placed on the Chinese market. Such database will be linked with current NMPA database with certification information, adverse event reporting system, and possibly national medical reimbursement scheme. All these measures are to integrate and link UDI into the existing pre-market approval and post-market surveillance. The aim is to break the bottleneck of historic isolated information and non-compatible coding and tracking system throughout device manufacturing, distribution, use and administration.
Implementation timeline are also based on risks and classifications approach. Below is a table to address the timeline for China, EU and the USA markets.
* China has two local issuing entities are to be designated shortly. One is ZIIOT, and another is Ali Health.
** Only for catalogue-listed trail products manufactured after 1st August 2020. Products with date of manufacturing earlier can be exempted. The first batch of key experimental devices are cardiac implants, brain implants and prostheses. Qserve can provide a detailed list upon request.
*** products in UDI extension letters are not included
**** provided that EUDAMED achieves full functionality by 26th May 2020
Impacts for foreign medical device manufacturers
In Europe, it is the manufacturer or labeler in the US who is responsible for assigning, registering UDI in local database, and placing carrier correctly on the label. In China, it is China agent’s responsibility to ensure UDI information is timely and accurately submitted on NMPA registration system and maintained it up-to-date in the UDID. China agent needs to be professional enough to understand requirements and keep an effective communication with overseas applicants. China agent is also held accountable to report UDI change within 30 days in the UDID.
When the incidents happened, such as if the UDI carrier is damaged or unreadable due to shipping/logistic process, if the selected China agent be eligible and capable to replace UDI in China could be a challenge.
NMPA require the accredited UDI issuing agencies must be a legal entity established in China, with adequate management and operation system, and conforms to China data security requirements. The agency is also required to guide manufacturers’ implementation process, upload its coding standards to the UDID, maintain them real-time and provide an annual report before 31st January each year. These criteria limit the eligible issuing entity to be only GS1 in China for now.
For those already UDI marked products, if their issuing entity follows ISO15459 standards (there are 45 issuing entities are up to April 2019), they are accepted by China authority too.
UDI will be an additional labelling requirement, to be added on top of local country labelling requirements.The UDI carrier shall be placed on the label of the smallest sales unit, and on all higher levels of packaging. China requires UDI to be assigned/marked on device Chinese labels & packages. This could impose additional time and cost for overseas manufacturers to re-assign and manage the existing labels and packings.
China implementation date for certain listed products may be earlier than Europe. It means European manufacturers may need earlier implementation ahead of schedule if they also intend to sell in the Chinese market.
Scanning environment in Chinese hospitals is lagging behind the latest technology. Although linear, 2D barcodes and RFID are all recognized, linear barcodes are the most common and welcomed way to be read by older and cheaper barcode scanners. 2D barcodes can contain much more content in much less space, however, many Chinese hospitals are not equipped with proper scanner to read and/or not connected to their internal distribution data management. When the barcodes dimensions are smaller than recommended due to space constraint, the barcode reading could be a practical issue.
UDI rules for Medical devices Order No.66
The Pilot Scheme for Medical Device UDI No.56
Basic Data Set of Unique Device Identification Database
Reporting Guide of Unique Device Identification Database and
YY/T 1630-2018 fundamental requirements for unique device identifier
YY/T 1681-2019 basic term of unique device identification system
Reporting Guide of Unique Device Identification Database
Gudid Data Elements Reference Table
UDI Guidance Unique Device Identification (UDI) of Medical Device
Global Unique Device Identification Database (GUDID)