Tamper-Evident Seals for Medical Device Packaging

A device that arrives in an altered or opened package isn't just bad for business — FDA rules say packaging has to protect against that from the moment it leaves the manufacturer.

General information, not legal advice — confirm current requirements with your quality team or regulatory counsel.

Tamper Evident Labels

Intertronix's Tamper Evident Labels, VOID Stickers & Security Seals seal device packaging, kits, and shipping containers so any opening or alteration is easy to spot before a device reaches the user. No artwork approval needed on stock items, and custom sizes are available for regulated packaging runs.

Why it matters

FDA's Quality System Regulation (21 CFR 820.130) requires device packaging and shipping containers to protect against alteration or damage during normal shipping, storage, and handling. For sterile devices, packaging also has to meet ISO 11607, the standard for keeping the sterile barrier intact until the device is opened for use. Neither one names a specific sticker or seal — but a tamper-evident label is a simple way to show that barrier wasn't broken before it got to the user.

Sources: FDA 21 CFR 820.130 · ISO 11607-1