\n| \n Class C<\/span><\/p>\n<\/td>\n | \n Moderate to high risk<\/span><\/p>\n<\/td>\n | \n Mandatory, stricter timelines<\/span><\/p>\n<\/td>\n<\/tr>\n\n| \n Class D<\/span><\/p>\n<\/td>\n | \n High risk (implantable, life-sustaining)<\/span><\/p>\n<\/td>\n | \n Mandatory, immediate compliance<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nIn addition, imported medical devices sold in India must carry UDI labels before entering the Indian market. Both domestic manufacturers and importers are responsible for compliance.<\/span><\/p>\n<\/span>Components of UDI: UDI-DI and UDI-PI Explained<\/b><\/span><\/h2>\nEvery <\/span>UDI for medical devices<\/b> has two components. Understanding both is essential before applying for compliance.<\/span><\/p>\n\n\n\n| \n Component<\/b><\/p>\n<\/td>\n | \n Full Form<\/b><\/p>\n<\/td>\n | \n What It Contains<\/b><\/p>\n<\/td>\n | \n Changes When<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n UDI-DI<\/span><\/p>\n<\/td>\n | \n Device Identifier<\/span><\/p>\n<\/td>\n | \n Manufacturer, device model, version, size<\/span><\/p>\n<\/td>\n | \n Device model or version changes<\/span><\/p>\n<\/td>\n<\/tr>\n\n| \n UDI-PI<\/span><\/p>\n<\/td>\n | \n Production Identifier<\/span><\/p>\n<\/td>\n | \n Lot number, serial number, expiry date, manufacture date<\/span><\/p>\n<\/td>\n | \n Each production run<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nTogether, UDI-DI and UDI-PI create a complete, unique identity for each device unit or lot. The UDI-DI is the static part that links to the device database. The UDI-PI is the variable part that tracks individual production information.<\/span><\/p>\n<\/span>UDI Labeling Requirements Under CDSCO<\/b><\/span><\/h2>\nCDSCO requires the UDI to appear on the device label and packaging in both human-readable form and machine-readable form. Here is what the labeling must include:<\/span><\/p>\n\n- The UDI code in plain text<\/span><\/li>\n
- A barcode or RFID tag carrying the UDI in machine-readable format<\/span><\/li>\n
- Accepted carrier formats: GS1 barcode, HIBCC barcode, or ICCBBA format<\/span><\/li>\n
- For implantable devices: UDI must appear on the device itself where technically feasible<\/span><\/li>\n
- All labeling must comply with the language and format requirements under MDR 2017<\/span><\/li>\n<\/ul>\n
CDSCO accepts the following issuing agencies for UDI assignment:<\/span><\/p>\n\n\n\n| \n Issuing Agency<\/b><\/p>\n<\/td>\n | \n Full Name<\/b><\/p>\n<\/td>\n | \n Accepted By CDSCO<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n GS1<\/span><\/p>\n<\/td>\n | \n Global Standards 1<\/span><\/p>\n<\/td>\n | \n Yes<\/span><\/p>\n<\/td>\n<\/tr>\n\n| \n HIBCC<\/span><\/p>\n<\/td>\n | \n Health Industry Business Communications Council<\/span><\/p>\n<\/td>\n | \n Yes<\/span><\/p>\n<\/td>\n<\/tr>\n\n| \n ICCBBA<\/span><\/p>\n<\/td>\n | \n International Council for Commonality in Blood Banking Automation<\/span><\/p>\n<\/td>\n | \n Yes<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/span>How to Obtain UDI for Medical Devices in India: Step-by-Step Process<\/b><\/span><\/h2>\nThe complete UDI compliance process for India runs through the CDSCO SUGAM portal and involves these steps.<\/span><\/p>\n<\/span>Step 1: Register with an Issuing Agency<\/b><\/span><\/h3>\nChoose GS1, HIBCC, or ICCBBA. Register your organisation and obtain a company prefix. This prefix forms the base of your UDI-DI codes.<\/span><\/p>\n<\/span>Step 2: Generate Your UDI-DI<\/b><\/span><\/h3>\nUsing your issuing agency’s system, generate a UDI-DI for each unique device model, configuration, and packaging level. Each variant gets its own UDI-DI.<\/span><\/p>\n<\/span>Step 3: Submit Device Information to CDSCO Database<\/b> | | | | | | | | |
![\"UDI](\"https:\/\/www.legalraasta.com\/blog\/wp-content\/uploads\/2026\/07\/UDI-for-Medical-Devices-in-India-1200x642.jpg\")
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