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Labelling Requirements

Medical device labelling requirements are set out in the HP(MD) Regulations 2010 and in HSA's guidance documents on labelling. The labelling of a registered device must match the labelling submitted to and approved by HSA at the time of registration.

Mandatory label elements​

Medical device labels supplied in Singapore must include:

  • Device name and model number;
  • Manufacturer's name and address;
  • Registrant's name and address (for imported devices — the Singapore registrant);
  • Device registration number (from the SMDR) — format: HSA/MD/[number];
  • Lot number or serial number (for traceability);
  • Expiry date (where applicable — sterile devices, IVDs, etc.);
  • Storage conditions (where applicable);
  • Instructions for use or reference to IFU (must be provided in English);
  • Single use symbol (where applicable) — ISO 7000-1051;
  • Sterile indicator (where applicable);
  • Warnings and precautions relevant to safe use.

Language requirements​

Labelling must be in English. Where labelling is also provided in other languages, the English text must be at minimum equally prominent.

IFU language​

Instructions for use must be provided in English. Where the device is also intended for use by lay persons (e.g. home-use IVDs), the IFU must be written in plain, accessible language.

Official sources​