Anmerkung vom 30. September 2020: Verlängerung der UDI-Frist Chinas für Hochrisikogräte Class III bis zum 01. Januar 2021
Einhaltung der UDI-Frist Chinas vom 1. Oktober 2020 für Hochrisikogeräte mit atrify. Die UDI-Registrierungsanforderungen nehmen weltweit weiter zu und China ist das nächste große Ziel. Chinas National Medical Products Administration (kurz: NMPA) ist die chinesische Regulierungsbehörde, die die chinesische UDI-Datenbank unterhält, welche über GS1 China mit dem Global Data Synchronization Network (kurz: GDSN) verbunden ist.
UDI registration requirements continue to expand around the world and China is the next big target. China’s National Medical Products Administration (in short: NMPA) is the Chinese regulatory agency that maintains the China UDI database, which is connected to the Global Data Synchronization Network (in short: GDSN) through GS1 China. Submissions to NMPA are required for medical devices sold in China based on the types of devices and timelines:China’s NMPA Timelines (as per August 24, 2020)
- Testing device submissions with GDSN through atrify is open NOW!
- 1st Oct 2020 – Complete submissions of High-Risk Class III devices
- 1st Aug 2022 Complete submissions of the remaining of Class III devices–
- 1st Aug 2024 – Complete submissions of Class II devices –
- 1st Aug 2026 – Submission of all Remaining devices:
atrify is ready to support you testing with NMPA!
GS1 China and the NMPA are ready to test manufacturers’ data received from atrify. atrify has been engaging directly with GS1 China and the NMPA for the last 4 months on the process and submission requirements and have already worked with several device manufacturers to successfully submit items to the NMPA’s test environment. In addition, we have developed the needed quality checks to ensure smooth submissions to both GS1 China and the NMPA. The NMPA data model is fully supported by atrify’s message-based connections. We continue our excellent collaboration with GS1 China and continue to stay aligned on the GDSN processes and procedures to keep fully up-to-date with any new NMPA requirements. Hua Wang from GS1 China says “We really appreciated working with atrify during this pilot phase, for their dedication and deep understanding of our requirements.”
atrify Healthcare Solutions – One platform for all your requirements
Your needs and requirements are at the centre of our solutions for the healthcare sector. atrify maintains a truly global GDSN based data syndication platform that delivers quality and expertise to over 2,000 companies in 50 markets globally. atrify has huge expertise to support customers globally in meeting various requirements. For example, we have maintained a connection to the FDA’s GUDID database since 2014 and are the only GDSN data pool that has an operational connection to the EU’s EUDAMED testing environment. We also handle nearly 80% of the medical device (GDSN) data exchange in Germany. We at atrify are committed and focused on providing community-based data synchronization services and are a recognized global leader in GDSN and GS1 Standards. Our delivery approach eliminates the risks and complexities found in multiple partnership delivery models with other service providers.