1, UDI implementation of the pressure to implement the implementation of time is not enough to estimate.
UDI is mandatory to promote the provinces and cities have time requirements, new products must be listed UDI.
Many companies have not yet implemented UDI, the reason is that the temporary will not be the full implementation of UDI, or even if the implementation of the implementation of the enterprise can also quickly complete the implementation.
Because the number of products varies from company to company, the length of time it takes to implement UDI varies. If the UDI implementation cycle is too long due to the large number of products, when the UDI is formally promoted, there is insufficient time left for the enterprise to complete the relevant work in a timely manner, resulting in the enterprise's products not being able to be marketed and sold in the region where the UDI has been implemented.
According to the latest requirements, when a product applies for initial registration, continuation or change of registration, the applicant or registrant should submit the product identification of its smallest sales unit (UDI-DI) in the registration management system. If the UDI-DI is not filled out in the application form as required, the application form cannot be submitted and the registration declaration will not be signed.
2. The cost of UDI implementation is underestimated and the UDI rules are difficult to learn.
Because of the complexity of the UDI coding rules, different management categories, packaging levels, device types of medical devices have corresponding coding rules, enterprises to implement UDI on their own, need to set up a professional team, their own product coding, not only the project is large, costly, and difficult to manage.
3, the implementation of a weak foundation, the coding standardization problems there are hidden dangers.
Currently, UDI in China is still an emerging field, only 48% of the medical devices on the market there is coding, the implementation of product coding in many companies there is no software or equipment to support the implementation of product coding, enterprises in the specific implementation of the process is often faced with a number of specific problems. If there is no correct understanding of UDI-related policies, blind UDI implementation, will lead to the details of the implementation of non-standardized, there is a greater operational risk.
For example: minimum packaging issues? Packaging hierarchy issues? What is IVD? How to label independent software? ......
Any of these issues may lead to coding errors, which not only affect the product launch, but also return to the factory to re-rectify, which is time-consuming and increases costs.
4, data management security problems.
Currently, many companies in the implementation of UDI, did not deploy UDI database, and only use Excel tables to save and manage the relevant data.
On the one hand, if the use of excel tables to manage UDI-related data, easy to cause data loss and errors, data management costs are high. On the other hand, when you need to re-call the related data in the later stage, you have to spend a lot of time to find the data source file, which is not in line with the relevant national norms.
5. High risk of trial and error, easy to chain problems during the assignment process.
UDI is directly linked to the production of enterprises, if the code, reading problems will lead to the whole batch of enterprise products back to the factory.
In the actual production process, different production lines, different products need to correspond to different coding equipment. Medical device coding methods are mainly high-resolution coding, variable data printing, thermal transfer printing, labeling, laser marking and barcode printing.
Since the products are usually packaged in multiple layers, the coding technology involved in different packages may be different, so when building coding equipment for UDI, you need to have a better understanding of the products and the production line, in order to avoid improper selection of equipment and scenarios that may lead to non-compliance with the coding or reduce the productivity of the production line.
6, the implementation of high cost, detection process uncertainty.
Many companies in order to deal with UDI to set up a dedicated team, re-development of the management system, adjust the code, the cost increase of at least 500,000 / year.
After completing the UDI coding, companies need to test the compliance of coding and labeling to ensure that their products are coding compliant. For example, is the code attached to the product packaging compliant with AIDC+HRI readability requirements? Is the printed code defective and can it be read effectively?
If this is not the case, it is inevitable that errors will occur, resulting in unrecognizable codes for products that are already on the market and not compliant with the relevant specifications.
--UDI Public **** Platform