From 20 June 2026, new rules on medical device labeling and instructions issued by Thailand’s Ministry of Public Health (MOPH) came into force, fully replacing the labeling provisions in use since 2020.
The new rules not only redefine the content requirements for labels and accompanying documents (Instructions for Use, IFU), but for the first time set specific provisions for electronic IFUs, Software as a Medical Device (SaMD), mobile applications and dental devices – an important update to Thailand’s medical device compliance system in recent years.
1. Background
According to the Thai government website thailand.go.th, Deputy Government Spokesperson Lalida Periswiwatana said that under Prime Minister Anutin Charnvirakul, the government has made public safety of health products a priority, and the Ministry of Public Health has therefore modernized medical device labeling and documentation requirements to suit today’s healthcare environment.
The Notification on Rules, Procedures and Conditions for Medical Device Labels and Instructions for Use (B.E. 2568, i.e. 2025) was published in the Royal Gazette on 22 December 2025 and takes effect from 20 June 2026, replacing the labeling rules issued in 2020. The Thai FDA consulted publicly on the draft in March–April 2025; this is the final version.
2. Key Change 1: Label Content and Language Requirements
The new rules require labels and documents provided by all manufacturers, importers, licensed distributors and registered operators to be complete and clear, without false, exaggerated or misleading efficacy claims. Labels and IFUs must include at least:
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Product name and intended use
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Instructions for use, warnings, contraindications and precautions
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Lot number, date of manufacture and expiry date
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Name and address of the manufacturer or importer
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Thai Food and Drug Administration (Thai FDA) registration number
On language, the rules distinguish two use scenarios: labels and IFUs of medical devices intended for home use by lay consumers must be in Thai, while professional devices used by healthcare professionals may be labeled in Thai, English or both.
3. Key Change 2: Electronic IFUs Allowed
For the first time, the rules allow electronic IFUs to be provided via digital channels such as QR codes and official websites, making it easier for the public and healthcare staff to access product information. This is especially important for Software as a Medical Device (SaMD): because such products have no physical packaging or natural carrier for a paper IFU, electronic IFUs offer a compliance solution better suited to the product.
4. Key Change 3: Specific Requirements for SaMD, Mobile Apps and Dental Devices
For the first time, the rules set Unique Device Identification (UDI) requirements for software medical devices: SaMD in risk Class 2 (moderate), Class 3 (moderate-high) and Class 4 (high) must show a UDI on the label or electronic IFU. Companies already holding UDIs in IMDRF member markets such as the US and EU can connect relatively smoothly with the Thai compliance pathway, the main additional task being submission of master data to the Thai FDA UDI database.
The rules also contain targeted provisions for mobile health apps and dental devices to ensure their safety can be effectively verified. Notably, professional-use SaMD follows the same language rules as professional devices – the software interface and IFU may be in English – while health apps for lay consumers must provide Thai content.
5. Two-Year Transition Period
To help companies transition smoothly, the rules provide a two-year grace period for existing stock: products manufactured under the old labeling rules before the new rules took effect (i.e. before 20 June 2026) can have their packaging updated within the two-year grace period, without immediate recall or relabeling, reducing the impact on existing supply chains and inventory management.
6. Recommendations for Companies
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Review existing labels and IFUs to check that they cover all information items required by the new rules (product name, use, warnings, lot number, expiry date, manufacturer/importer information and Thai FDA registration number, etc.)
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Assess the classification of home-use vs. professional-use products and confirm the corresponding language strategy (Thai / Thai-English / English)
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For SaMD, assess early whether the risk class (2–4) triggers UDI labeling obligations, and plan how to deploy electronic IFUs (QR code/website)
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Take stock of existing inventory and packaging materials and plan phased updates within the two-year grace period, to avoid capacity and cost pressure at the end of the window
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Keep track of further Thai FDA guidance and the interplay with the MDA–Thai FDA Regulatory Reliance Programme, adjusting regional compliance strategies in time
Note: the new Thai labeling rules coincide with the full implementation of the bilateral regulatory reliance programme between Malaysia’s MDA and the Thai FDA (covering Class B, C and D devices), reflecting that Southeast Asian medical device regulation is accelerating along two main lines: modernized standards and regional cooperation. When developing a compliance strategy for Thailand, companies should consider label updates together with optimization of the registration route.
If you need further support with product applicability, label compliance review or transition planning, contact us – the EVERBIZ team will provide professional advice based on your products.