Labelling & Language Requirements
TH-Unique · Thai language mandatory for home-use · 180-day grace period
Labelling Requirements — MoPH Notification 137
All Thai FDA-registered devices must carry labelling complying with MoPH Notification 137 on labelling requirements.
Mandatory Label Contents
| Element | Requirement |
|---|---|
| Device name / trade name | Required |
| Manufacturer name and address | Required |
| License holder (AR/importer) name and address | Required — Thai regulatory contact |
| Thai FDA approval number | Required — the Listing/Notification/License reference |
| Lot / batch number | Required |
| Manufacturing date | Required |
| Expiry date | Required where applicable |
| Storage conditions | Required where specific conditions apply |
| Intended purpose | Required where not self-evident |
| Warnings and precautions | Required for safety-critical information |
| Single-use symbol | Required where applicable |
Thai Language Requirements — TH-Unique
Thailand has specific language requirements that differ based on the intended user:
Home-Use Devices — Thai Language Mandatory
Devices intended for use by lay users / patients at home must have all labelling and IFU in Thai language. This is mandatory — English-only labelling is not acceptable for home-use devices.
Examples of home-use devices requiring Thai labelling:
- Blood glucose meters and test strips
- Home blood pressure monitors
- Pregnancy test kits
- Temperature thermometers
- Home nebulisers
- Pulse oximeters for home use
Professional-Use Devices (Physician / HCP Use Only) — Thai or English
Devices intended for use only by healthcare professionals (in hospital or clinical settings) may have labelling in Thai or English — both are accepted.
Examples:
- Surgical instruments
- Hospital imaging equipment
- Intensive care monitors
- Operating theatre devices
180-Day Grace Period for Label Affixing — TH-Unique
A distinctive Thai FDA provision allows importers to affix Thai labels after import rather than requiring pre-labelled devices:
- Imported devices may arrive without complete Thai labelling
- The importer has 180 days from the date of import to affix the required Thai labels
- During this 180-day period, the devices must remain in the importer's controlled storage — they cannot be distributed without proper Thai labelling
- After 180 days, all distributed devices must carry compliant Thai labelling
Practical application: This provision is particularly useful for:
- Managing multi-market inventory (product manufactured with global labelling)
- Reducing the lead time impact of Thailand-specific label versions
- Smaller import volumes where pre-labelling is not commercially practical
Promotional Claims
All promotional claims must:
- Be truthful and not misleading
- Be consistent with the approved intended purpose
- Be evidence-based — supported by data in the approved dossier
Claims that exceed the approved indication or make unsubstantiated performance claims are prohibited.