A complete UDI includes DI and PI, where DI is the product identification (static information), including enterprise information and product specifications and models, etc.; PI is the production identifier (dynamic information), which includes the production date, expiration date, production batch, serial number, check digit, etc.
Based on the changes in the requirements of the state and various provinces and cities for production enterprises to declare UDI, the promotion of UDI can be divided into two stages: the DI era and the PI era.
Di eraIt means that in the past few years, the regulatory authorities have only required enterprises to declare product DI, and there are no mandatory provisions for PI, so in the production system of enterprises, UDI-related work is carried out around DI. **Regulatory authorities are also unable to effectively trace the company's products.
With the promotion of UDI, the demand for PI in the supervision, circulation, and use links is getting louder and louder. China's medical device management is about to enter a new era - the PI era.
The PI eraIt means that enterprises need to upload all UDI information, truly achieve one thing and one code, which can record and track the production, use and safety of medical devices, bring more powerful data support and operation convenience to manufacturers, circulation enterprises and users, and provide consumers with better medical services and health management.
Take udi 4The 0 platform, for example, is designed for the PI era, which not only reconstructs the underlying architecture, but also greatly meets the needs of PI management at the operation and application level. At the same time, the supporting research and development of UDI code scanning equipment "Youyou Scan", tag detector, etc., all provide a better choice for enterprises in the PI era for the management and application of UDI data.
For example, when consumers buy medical device products, they can scan the UDI code through their mobile phones to obtain the company's information, production information, logistics information, etc., identify counterfeit and shoddy products, expired products, etc., and safeguard the rights and interests of consumers.
According to the feedback of a number of enterprises, Tianjin, Henan, Hainan, Guangdong and other provinces and cities have gradually begun to promote the work of PI, including the establishment of a provincial-level regulatory platform, the convening of enterprise symposiums, the development of enterprise demand research, etc., it is expected that in the near future, the corresponding policies and regulations will be introduced, officially ushering in the PI era!