Skip to main content

Labelling Requirements

TR-007 · HK-unique bilingual requirement

Minimum Label Contents​

  • Device name/trade name
  • Manufacturer name and address
  • LRP name and address (HK contact)
  • Lot/batch number or serial number
  • Manufacturing date and/or expiry date
  • Intended purpose (if not obvious)
  • Warnings and precautions
  • Single-use symbol (if applicable)

Bilingual Requirement — English & Chinese​

HK-unique: Devices intended for home use or lay users must be labelled in both English and Chinese.

Professional-use devices (used only by trained clinicians) may use English or Chinese only, but bilingual is always safer for market acceptance.

IFU (Instructions for Use)​

  • Must accompany the device unless the label alone is sufficient
  • Home-use IFU must be bilingual
  • Electronic IFU (eIFU) may be acceptable for certain professional-use devices

Promotional Claims​

Must be truthful, not misleading, and consistent with the MDACS-listed intended purpose.

For devices with severely constrained label space, electronic labelling (eLabelling) or QR code linking to bilingual information may be acceptable with prior approval from MDD. Consult the MDD during listing if label space is a constraint.