Thailand Medical Device Labeling Regulations 2025: MOPH Updates Requirements for Labels and Instructions for Use (IFU)

On 22 December 2025, the Ministry of Public Health of Thailand (MOPH) has issued new medical device labeling requirements under the Notification of the Ministry of Public Health: Criteria, Procedures, and Conditions for the Labeling and Instruction for Use of Medical Devices B.E. 2568 (2025).

 

What's Changed?

The B.E. 2568 (2025) announcement introduces the following major updates:

▸  Adds specific labeling and IFU requirements for certain medical devices
▸  Reduces the grace period for completing the labelling requirement from 180 days to 120 days after customs clearance

 

Key Update #1: Specific Labeling and IFU Requirements

Labelling and IFU for Software as Medical Devices (SaMD)

At least following information must be shown on labelling or IFU:

▸  Product Name
▸  Indication or Intended Uses
▸  Device Description (Main Components/Principle of Operations/Types)
▸  Name of: Product Owner or Physical Manufacturer
▸  Version, Lot, or Serial number of the software
▸  (If available) Contraindication, Warning, and Precaution
▸  (If available) Unique Device Identification

For SaMD without physical form, labeling and IFU can be provided electronically in either Thai or English. Where a physical component exists, the label must be affixed to the physical part accordingly.

Labelling and IFU for Reusable Surgical and Dental Instruments

At least following information shall be displayed in Thai or English:

▸  Product Name
▸  Name and address of:
        ▹ Product Owner or Physical Manufacturer
        ▹ Importer (for imported devices)
▸  Lot number or Serial Number (Abbreviations or symbols may be used)
▸  For products without a specified useful life:
        ▹ Date of manufacture in format of YYYY/MM or MM/YYYY (Abbreviations or symbols may be used)
▸  For products with a specified useful life:
        ▹ Expiry date in format of YYYY/MM or MM/YYYY, or specifying the period of use from the date of manufacture (Abbreviations or symbols may be used)

Labelling and IFU for Accessories

At least following information shall be shown in Thai or English:

▸  Product Name
▸  Name and address of:
        ▹ Product Owner or Physical Manufacturer
        ▹ Importer (for imported devices)
▸  Lot number or Serial Number (Abbreviations or symbols may be used)
▸  For products without a specified useful life:
        ▹ Date of manufacture in format of YYYY/MM or MM/YYYY (Abbreviations or symbols may be used)
▸  For products with a specified useful life:
        ▹ Expiry date in format of YYYY/MM or MM/YYYY, or specifying the period of use from the date of manufacture (Abbreviations or symbols may be used)
▸  Thai FDA Approval Certificate Number

Notes:

▸  Separately registered accessories must have their own labels/ IFU, and shall meet all minimum requirements at customs clearance.
▸  Accessories registered together with main device and packed together in the same package may use a unified label on the main device.

 

Key Update #2: Minimum requirements of Labels at Customs Clearance.

Prior to selling medical devices, manufacturers and importers must ensure that labels and IFU fully comply with Thai FDA labelling regulations within 120 days after customs clearance, shortened by 60 days from the previous 2020 announcement.

Minimum requirement of labels for customs clearance include:

▸  Product Name
▸  Name and address of:
        ▹ Product Owner or Physical Manufacturer
▸  Lot number or Serial Number (Abbreviations or symbols may be used)
▸  For products without a specified useful life:
        ▹ Date of manufacture in format of YYYY/MM or MM/YYYY (Abbreviations or symbols may be used)
▸  For products with a specified useful life:
        ▹ Expiry date in format of YYYY/MM or MM/YYYY, or specifying the period of use from the date of manufacture (Abbreviations or symbols may be used)

 

What Remains Unchanged?

The following requirements remain consistent with the previous B.E. 2563 (2020) announcement.

Language Requirement: Home Use & Professional Use

For Home-Use Devices, all labels and IFUs must be provided in Thai.

For Professional-Use Devices, the Thai FDA allows labels and IFUs to be provided in either English or Thai.

In both cases, other additional languages are optional and must not conflict with English or Thai versions.

List of Requirement

No.	Requirement	Labels	IFU
1	Product Name	✔	✔
2	Device Description (Main Components / Principle of Operations / Types / Species)	–	✔
3	Indication or Intended Uses	✔ (Exempted if labels have insufficient space)	✔
4	Packaging Size	✔	–
5	Instruction for Use (Except devices that are obvious to use)	–	✔
6	Name and address of: ▸  Product Owner or Physical Manufacturer ▸  Importer (for imported devices)	✔	✔
7	Thai FDA Approval Certificate Number	✔	–
8	Contact Information	–	✔ (Not required in the IFU if provided on the label)
9	Lot number or Serial Number	✔ (Abbreviations or symbols may be used)	–
10	Date of manufacture (YYYY/MM or MM/YYYY) (For products without a specified useful life)	✔ (Abbreviations or symbols may be used)	–
11	Expiratory Date (YYYY/MM or MM/YYYY) or specifying the period of use from the date of manufacture (For products with a specified useful life)	✔ (Abbreviations or symbols may be used)	–
12	Storage Condition	–	✔
13	Contraindication, Warning, and Precaution	–	✔
14	(If any) Date of Revision/Document number	-	✔

Note: If the requirements under items 1-3, 5-6, 8, 12-13 are already clearly available on the labels, IFU is not required.

 

Critical Compliance Dates

Enforcement Date: June 20, 2026 – The B.E. 2568 (2025) labeling announcement takes effect.

Transition Period: Until June 20, 2028 – Medical device labels and IFU compliant with B.E. 2563 (2020) requirements remain valid 2 years after the B.E. 2568 (2025) announcements come into force.

 

Does This Announcement Apply To All Medical Devices?

The following medical devices are excluded from this announcement:

▸  Devices that are regulated under specific announcements (e.g. Contact lenses, HA fillers, Blood bags, etc.)
▸  Devices exempted under Section 27 of the Medical Devices Act
▸  Devices manufactured or imported for export only

 

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References

1. Summary of the Ministry of Public Health Notification on Medical Device Labeling and Instructions for Use, B.E. 2568 (2025)
2. Notification of the Ministry of Public Health Re: Criteria, Procedures, and Conditions for the Labeling and Instructions for Use of Medical Devices, B.E. 2568 (2025)