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 (2–8°C range) must be transported in validated cold chain packaging or temperature-controlled vehicles, with temperature monitoring logs (including minimum and maximum temperatures recorded) for each shipment. Documentation should be retained for at least 5 years.
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.
Transport operators and importers are jointly responsible for maintaining storage and transport conditions throughout the supply chain. Documentation of temperature monitoring (time-stamped logs) must be retained and made available to ANVISA during inspections or post-market surveillance activities. Failure to maintain specified conditions may trigger product recalls or regulatory action.