Storage & Transport Conditions
Medical devices must be stored and transported under conditions that preserve their safety, quality, and performance throughout the supply chain. Requirements are set by:
- The device's registered specifications (from the technical dossier);
- ANVISA labelling requirements (RDC 754/2022) — storage conditions must be stated on the label; and
- RDC 752/2022 — GMP requirements for distribution and storage.
Key storage requirements:
| Device type | Typical storage requirement |
|---|---|
| General medical devices | Room temperature (15–30°C), protected from moisture |
| Sterile devices | As per sterile barrier validation (typically room temperature) |
| Cold chain devices | 2–8°C (refrigerated) or as specified |
| Frozen devices | Typically -15°C to -25°C |
| Radiation-sensitive devices | Shielded from ionising radiation |
Cold chain devices must be transported in validated cold chain packaging or temperature-controlled vehicles, with temperature monitoring logs for each shipment.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.
Storage and transport conditions are also governed by RDC 751/2022 (Technical Regulation for Medical Devices), which sets out the overall requirements for device registration and technical specifications, including stability and shelf-life conditions.