Thailand: (Draft) Criteria, Methods, and Conditions on Labeling and Documentation (IFU) for Medical Devices

Clause 1
This announcement shall come into force from the day following its publication in the Government Gazette.

Clause 2
The Ministry of Public Health’s announcement on the criteria, methods, and conditions for labeling and documentation of medical devices B.E. 2563 (2020) is hereby rendered ineffective.

Clause 3
This announcement does not apply to the following cases:

• Medical devices for which specific labeling and documentation regulations have already been established
• Medical devices exempted from manufacturing or importation requirements under Section 27 of the Medical Device Act B.E. 2551 (2008) and its amendments
• Medical devices manufactured or imported solely for export outside the Kingdom

Clause 4 – Definitions

• Home Use Medical Device: A medical device intended for use by laypersons at locations without medical facility characteristics, such as residential homes. This also includes devices prescribed by medical personnel for use outside medical facilities.
• Professional Use Medical Device: A medical device not intended for layperson use but for healthcare professionals or under their supervision.

Clause 5
Medical device manufacturers and importers must ensure that labeling and documentation are in accordance with Clauses 6, 7, or 8, with clear visibility. All information provided must be truthful, non-exaggerated, and not misleading.

Clause 6 – Labeling Requirements

• Labels for home use medical devices must be in Thai and clearly readable.
• Labels for professional use medical devices must be in either Thai or English. Additional languages may be included if they do not contradict the Thai or English text.
• Labels must be displayed on the device or its packaging in a visible and readable manner and must contain at least the following information:
  • Product name
  • Intended use or indications (if not on the label, it must be in the accompanying documentation)
  • Quantity or volume
  • Name and location of the manufacturer or importer. If imported, the name of the manufacturing facility, city, and country must be displayed. If the physical manufacturer is not listed, the name of the product owner, city, and country of the product owner, and the country of the manufacturer must be provided.
  • License number or registration details
  • Lot number, serial number, or production batch
  • Manufacturing date (YYYY format, 4 digits) if there is no shelf-life
  • Expiration date (YYYY format, 4 digits) if there is a shelf-life
  • For items 6–8, the information may be in English or represented by English abbreviations or symbols.

Clause 7 – Labeling for Software-Based Medical Devices
Medical device software, applications, or similar digital products (intangible form) must provide labeling electronically in Thai or English. Additional languages may be used if they do not contradict the primary language. The labeling must include:

1. Product name
2. Intended use and indications
3. Device description (components, functions, type)
4. Manufacturer’s or product owner’s name
5. Version number
6. Warnings or precautions (if any)
7. Unique Device Identification (UDI) for medical devices under Class 2, 3, and 4 (if any)

For software, applications, or similar entities that are packaged in physical form, the labeling details listed above must appear on the packaging. The instructions for use (IFU) may be provided in electronic format.

Clause 8 – Labeling for Reusable Surgical and Dental Instruments
Reusable medical and dental instruments or accessories must have labeling in Thai or English, with optional additional languages that do not contradict the primary language. Required details include:

1. Product name
2. Name and location of the manufacturer or importer. If imported, the name of the manufacturing facility, city, and country must be displayed. If the physical manufacturer is not listed, the name of the product owner, city, and country of the product owner, and the country of the manufacturer must be provided.
3. Lot number, serial number, or batch number
4. Manufacturing date (YYYY format, 4 digits) if there is no shelf-life
5. Expiration date (YYYY format, 4 digits) if there is a shelf-life
6. License number (for accessories only)

• For items 3–5, the information may be in English or represented by English abbreviations or symbols.

Clause 9 – Medical Device Instructions for Use (IFU)

• Home-use medical devices not covered under Clauses 7 and 8 must provide IFUs in Thai. Additional languages may be used as long as they do not contradict the Thai text. The IFU must include:
  • Product name
  • Key specifications
  • Intended use and indications
  • Usage instructions (unless inherently clear)
  • Contact details for further information or complaints
  • Storage conditions
  • Warnings, contraindications, or precautions (if applicable)
  • Date of issue or latest revision

If all the above information is already present on the label, a separate IFU is not required.

• Professional use medical devices must include English-language documentation at a minimum.

Clause 10
Instructions for use and manuals may be provided in paper or electronic formats, such as CDs, QR codes, or websites.

Clause 11 – Labeling at Port of Entry
Importers must present Thai or English labeling for inspection at the port of entry. Labels must include:

1. Product name
2. Manufacturer’s details (including city and country)
3. Lot number, serial number, or batch number
4. Manufacturing date (YYYY format, 4 digits) if there is no shelf-life
5. Expiration date (YYYY format, 4 digits) if there is a shelf-life

All labeling and documentation must be completed before the product is sold and within 30 days of customs clearance.

Clause 12
In case of disputes or questions of interpretation, the Secretary-General has the authority to make the final decision.

Clause 13 – Transition Period
Medical devices labeled in compliance with the 2020 regulation may continue to be used for up to two years from the effective date of this announcement.

The draft is available for review here: https://medical.fda.moph.go.th/media.php?id=742576347053957120&name=hearing34.pdf