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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.