UDI
Preparing for Australian UDI obligations.
Unique Device Identification is becoming an important part of medical device traceability globally. Manufacturers entering Australia should begin organising product identifiers, data ownership, and ARTG-linked records early.
Why UDI readiness belongs in market access planning
UDI is not only a barcode exercise. It touches product master data, labelling, packaging, variant management, change control, sponsor records, and post-market traceability. If product data is inconsistent across global systems, distributor records, and ARTG entries, later compliance work becomes harder.
What to organise
- Device identifiers and product variant structure.
- Labelling and packaging data ownership.
- ARTG entry mapping and sponsor record management.
- Change control for product names, models, packaging, and manufacturing sites.
- Alignment with global UDI, quality, and post-market systems.
How Ocevia helps
Ocevia helps manufacturers assess UDI readiness as part of broader Australian market access planning. This includes identifying data gaps, clarifying sponsor responsibilities, and preparing product records that can be maintained across the lifecycle.