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 and marketing materials misleading; and any restrictions in the approval letter; clinical or performance included or published peer-reviewed literature; Not make disease claims or imply efficacy for unapproved indications.
- 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.
Significant labelling changes include: changes to intended purpose statements, safety warnings, contraindications, or usage instructions. Minor changes (e.g., manufacturer contact updates with no safety impact, translations to additional languages) may not require formal variation notification — confirm with MDCD if unclear.