The National Medical Products Administration (NMPA) is the regulating body in China for drugs and medical devices. The NMPA is the authoritative group that drafts laws and regulations for drugs, medical devices, and cosmetics. They also establish medical device standards and classification systems for the Chinese market. For all categories of medical devices, the NMPA has departments that regulate medical device registration (pre-market approvals) and supervision (post-market requirements). NMPA has implemented an electronic medical device registration management system and has identified Unique Device Identifier (UDI) requirements. Although the regulatory process can be challenging due to rapid change, bringing medical devices to market in China is a high-potential future growth area for many US manufacturers.
To prepare the world market for regulatory compliance in China, NMPA has published guidance on medical device UDI and require registration and UDI data submission for specific product classes. A UDI pilot began in 2019 and has continued to the present. The first group of products (Group 1, consisting of 64 categories of high-risk implantable devices) was required for UDI data submission 2021 January (shifted from 2020 October). Additional medical device classes will follow with UDI data submission deadlines.
Note: Timeline is current interpretation; subject to change
Reed Tech has been planning and developing connectivity for NMPA for some time. China UDI requires about fifty data attributes. About half of these attributes are already supported by Reed Tech SingleSource™ for Medical Devices. To date, preliminary case scenarios are already in the test development phase. It is anticipated that some business rules will materialize and change between now and the 2020 October UDI submission date. We will continue to monitor and update our systems accordingly.
What we have learned about the NMPA UDI database and GDSN
Can NMPA UDI compliance be achieved by publishing medical device product data via a Global Data Synchronization Network (GDSN) data pool?
It is important to note that the NMPA is not subscribing to a GDSN data pool, and therefore UDI submissions cannot be fulfilled via the GDSN network naturally. GS1 China, however, is working through a pilot to support its customers by developing a connector from their data pool to the NMPA UDI database, presumably using the same machine-to-machine API connection approach available to all manufacturers and third-party submitters. The pilot may also uncover the need to modify the GDSN dataset to support all the attributes defined in the NMPA UDI data record.
Should GS1 China’s pilot result in success, the submission method will only be available to those manufacturers with subscriptions to the GS1 China data pool. This is a similar approach to what we have seen with the US FDA GUDID – any data pool looking to support submissions to the UDI database will need to develop or license their own specialized connector to perform the mapping and transformations to and from the regulatory UDI database and the source data pool.
More Assistance and Information
Reed Tech provides valuable assistance and expertise in preparing for UDI submission to China (NMPA) and participation in the machine-to-machine submissions to the NMPA UDI database. If you have questions on datasets and NMPA test submissions, contact us for more information. Email: [email protected]
2019-Jul-03: Draft UDI Dataset & UDI Guide
2019-Aug-27: UDI Rules & Interpretation Guide (eff 2019-10-01); details on class-phased implementation later