In March 2026, the National Medical Products Administration (NMPA) issued two new announcements on the implementation of the Unique Device Identification system for medical devices. Announcement No. 21 (2026) sets out the mandatory timetable for UDI coverage of all device categories and the rules for registration and filing. Announcement No. 15 (2026) provides the detailed supporting rules for Announcement No. 21 and clarifies the scope of exemptions.
Companies preparing medical device UDI for the first time all want to know where the difficulties lie. Here I share insights from my own hands-on experience with multiple projects:
Q&A
Q: Are there rules for choosing an issuing agency? What should we pay attention to?
A: Companies must choose a compliant issuing agency publicly listed by the National Medical Products Administration (NMPA). Because the main compliant issuing agencies each have different strengths, we recommend considering three factors when choosing:
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Market scope (domestic or international);
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Product packaging and size;
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Cost and system integration. Companies usually need to pay a membership fee and an annual fee, and should consider whether the chosen agency’s ecosystem is mature – for example, whether ERP and WMS systems natively support its coding system.
Q: How are the DI and PI of a medical device UDI generated? What should we pay attention to?
A: The steps are generally as follows:
(1) Obtain the company prefix (manufacturer identification code);
(2) Compile the DI code. Using professional software ensures compliance and efficiency. An example of a complete compiled DI:
(3) Data submission. Upload to the NMPA database:
Log in to the NMPA UDI database (https://udi.nmpa.gov.cn/) and submit the DI and related product information;
(4) Likewise, using professional software to compile the PI code ensures compliance and efficiency;
(5) Note: after the PI is generated, it must be uploaded to the NMPA UDI database together with the DI, using one of the three methods the database provides: online entry, batch import or API interface.
In general, companies encounter difficulties and choices at every step of the process the first time, and making those choices requires specialist knowledge in the field. Most companies choose to work with a professional software service platform that offers comprehensive functions.
These service providers offer professional software for compiling PI codes, barcode printing after coding, and uploading UDI data to the NMPA database. Although this adds cost, it clearly improves efficiency.
Note: service platforms also quote for UDI barcode printers and consumables. Many companies purchase these themselves to save costs, but they need to consider whether UDI labels will be compliant, readable and durable:
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Printer compatibility: compatible with the service platform’s software and with the label size and material.
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Wear resistance, scratch resistance and corrosion resistance of the consumables (ribbon + label stock) in combination. Barcode quality should be grade C or above under ISO 15415 to ensure easy reading throughout the supply chain. Legibility must meet the requirement in YY/T 1942—2024 “Form and content of the unique device identifier for medical devices” that UDI labels withstand alcohol wiping.
Establishing a company’s medical device UDI coding in line with NMPA requirements usually takes several months.
Links to the original announcements: Announcement No. 21 (2026):
https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20260313152722157.html
Announcement No. 15 (2026):
https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20260313151505167.html
Conclusion
This is a series of educational articles introducing regulations and standards of the FDA, NMPA, GMP, CE MDR/IVDR and MDSAP.
EVERBIZ is happy to share medical device expertise with industry clients, and hopes our extensive practical experience in quality systems and product registration will be helpful.
Let’s contribute together to the development of the medical device industry – if you have any questions or needs, please contact us.
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
Shanghai: Room 909, Building 1, Lane 111 Luxiang Road, Baoshan District, Shanghai, China; Germany: Landsberger Str. 155, 80687 München, Germany
Austria: Innsbrucker Bundesstraße 136/3, 5020 Salzburg, Austria
Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong
Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520
