China’s National Medical Products Administration (NMPA) proposed major changes to medical device regulatory requirements by amending order No. 650 in June 2018. This amended regulation requires implementation of a Unique Device Identification (UDI) system for medical devices sold and used in China. In July 2019, the NMPA and National Health Commission (NHC) jointly started the UDI pilot work program, which is scheduled to be completed in July 2020.
On October 12, 2019, the first group of 64 Class III high-risk implanted devices that require the implementation of the UDI system was announced. As of October 1, 2020, the UDI rules will be mandatory for this first group of devices. The UDI requirement for other products will be implemented gradually, based on classifications and risk levels of medical devices.
On August 26, 2019, the NMPA officially released Order No. 66, Medical Device Unique Identification System Rules, which, and is similar to rules in place in other countries — the objective being to build a system that can fully identify a medical device throughout its entire lifecycle.
Under these rules, the smallest salable unit of a medical device marketed in China is assigned a Unique Device Identifier, and UDI details must be uploaded to the dedicated database before the product is placed on the market. The UDI system must comply with the rules formulated by the NMPA, and all stakeholders in the UDI supply chain have a part to play in the creation and implementation of this system.
A UDI must be a unique, alphanumeric code, which consists of two parts: DI (Device Identifier) and PI (Production Identifier). The DI is a unique fixed code specific to the manufacturer and model/specification of a device. The DI is also the identifier used to access the UDI Database (UDID). The PI is a variable code related to the production control process of the device. It may comprise a medical device serial number, production batch number, production date, expiration date, etc. The PI may vary based on device type and manufacturing practices.
The UDI needs to be represented in both AIDC (Automatic Identification and Data Capture) and HRI (Human Readable Interpretation) formats. A China UDI carrier may follow international standards as well, e.g., GS1 standards.
In July 2019, the NMPA and the NHC jointly issued a Medical Device Unique Identification System pilot work program, which specifies the guiding ideology, basic principles, work objectives and scope of the pilot work, responsibilities, tasks and schedules marking the official launch of the pilot work of China’s medical device UDI system.
In August 2019, a working group was formed to coordinate this pilot work. The pilot varieties focus on 64 Class III high-risk implanted devices such as heart and craniocerebral implants, and prostheses. Forty-five device enterprises and users from Shanghai were selected as the first group of pilot units, including the local manufacturer, import agents and users.
The pilot work that was started in July 2019 is divided into five stages:
The UDI Database was officially launched on December 10, 2019, with functions opened to pilot enterprises to apply for related data of unique identification of pilot varieties. In the ongoing step, the NMPA opened the unique identification database query and sharing services to the pilot units on March 2020 in accordance with the pilot work deployments.
The UDI system will be an additional labeling requirement, to be added on top of local country labeling requirements. The UDI carrier will be placed on the label of the smallest salable unit, as well as on all higher levels of packaging. This could impose additional time and cost for overseas manufacturers to re-assign and manage the existing labels and packings.
It will be the responsibility of the agent in China to ensure UDI information is timely and accurately submitted on the NMPA registration system and maintained in the UDI Database. The agent is also accountable to report UDI changes within 30 days in the UDI Database. If the UDI carrier is damaged or unreadable due to the shipping/logistics process, it could be a challenge for the agent in China to be able to replace the UDI. Overseas manufacturers will have to closely define a process with the agent.
The NMPA requires the accredited UDI issuing agencies to be legal entities established in China, with adequate management and operation systems, and to conform to China’s data security requirements. Agencies are also required to guide manufacturers in the implementation process, upload their coding standards to the UDI Database, maintain them in real time, and provide an annual report before January 31. Theselimit the eligible issuing entities and could impose additional time and cost for overseas manufacturers. Those products already marked with a UDI will be accepted by Chinese authorities as well, provided their issuing entity follows ISO 15459 standards.