ElendiLabs Logo
Back to Articles

Need Regulatory Help? Try Our Platform

Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.

Create Free Account
Registration

April 1, 2025

Approximately 5 minutes

Thailand Medical Device Local Labeling Requirements: Language, Content, and Post-Import Affixing

Thailand Medical Device Local Labeling Requirements

Medical device labeling in Thailand is governed by the Ministry of Public Health's Notification 137, specifically Section 260 D, which outlines the rules, procedures, and conditions for labels and package inserts. Proper local labeling is a mandatory component of market compliance.

🇹🇭 Language Requirements

The required language for medical device labeling depends on the device's intended user:

  • Home-Use Devices: Devices intended for use by the general public (home use) must be labeled in Thai.
  • Professional-Use Devices: Devices used directly by physicians may have their labeling in either Thai or English.

📝 General Labeling Content

All medical device labels and/or package inserts must include comprehensive information to ensure safe and proper use. Mandatory details include:

  • Product Identification: Name of the product, License number, Serial number or Batch number.
  • Manufacturer/Importer Details: Name and address of the manufacturer (and country), and the name and address of the importer.
  • Usage Information: Indication, Quantity, How to use instructions, Storage conditions.
  • Safety Information: Warnings, contraindications, and precautions.
  • Dates: Manufacturing date and expiry date (indicating the year in a four-digit format, e.g., 2025).

📦 Labeling Flexibilities and Exemptions

The Thai FDA allows for certain flexibilities in applying the required information:

  • Package Inserts: If required information cannot fit on the label, a separate package insert can be added. This insert can be in paper or electronic form (such as a QR code linking to a website or a CD).
  • Post-Import Affixing: The local importer is permitted to affix the necessary labeling within 180 days of the medical device entering the country.
  • Exemptions: Certain devices, such as those used for reusable surgery, may have limited labeling requirements, though they still must include essential data like the product name, manufacturer/importer details, batch/serial number, and manufacturing/expiry dates.

Ask Anything

We'll follow up with you personally.

100% response rate • Reply within 7 business days

Your email will not be published. We'll only use it to notify you when we respond.

Questions & Answers (5)

A
Guest

Our product is a Class 2 medical device with a 12-digit registration number. Is there a specific font size or border requirement for displaying the TFDA number on the local label? If we have an Advertising License Number for our marketing brochures, must that also appear on the physical product label?

ElendiLabs

The TFDA registration number (e.g., 69-x-x-x-xxxxxxx) must be printed clearly and be legible to the naked eye. While there is no mandatory "box" or border, it must be easily identifiable as the license number. Regarding the Advertising License Number (Kor.Por. No.), this is not required on the physical product label; it is only mandatory for promotional materials, websites, and brochures. Mixing the product registration number with the advertising number on the same label can lead to confusion during regulatory inspections.

G
Guest

We use the international YYYY-MM-DD format for our manufacturing and expiry dates. Some of our local distributors in Bangkok have suggested that the dates must be displayed in the Thai Buddhist Era (B.E.) format (e.g., adding 543 years to the Western year). Is this a mandatory requirement under the 2026 regulation, and does the TFDA accept abbreviations like "MFG" and "EXP"?

ElendiLabs

Under the new B.E. 2568 regulation, the TFDA accepts dates in the Christian Era (C.E.) using the 4-digit year format (e.g., 2026), which aligns with ISO 8601. You are not required to convert dates to the Buddhist Era for medical device labeling, though it is legally permissible. Regarding abbreviations, you may use "MFG" and "EXP," but they must be clearly defined in the Instructions for Use (IFU) or the accompanying documentation. The year must always be 4 digits to avoid ambiguity.

A
Guest

我们目前通过泰国的授权代表（AR）进行进口。由于全球包装统一，我们计划在货物进入泰国保税仓库后再加贴包含泰语说明和进口商信息的贴纸。听说新规缩短了加贴标签的期限，请问具体的时限是多少？如果未能在期限内完成，是否可以申请延期？

ElendiLabs

这是一个非常关键的变化。新条例将进口后完成标签加贴的时限从原先的 180 天缩短至 120 天。这意味着从货物清关放行之日起，您只有 120 天的时间完成所有合规标签的加贴工作。TFDA 目前不支持无理由延期，除非能证明存在不可抗力。若逾期未完成，该批次货物将被视为“未注册/违规器械”，面临高额罚款甚至吊销进口许可证的风险。

J
Guest

对于某些精密且体积较小的 3 类（Class 3）介入手术耗材，由于物理空间限制，我们无法将所有的警告和禁忌症印在包装上。2026 年新规是否允许我们通过二维码提供电子说明书？如果可以，标签上是否仍需保留泰语的“基本信息”？

ElendiLabs

新规极大地鼓励了数字化转型。对于专业使用（Professional-use）的器械和软件类器械，TFDA 明确允许使用 e-IFU（通过二维码或网站）。但是，您不能完全取消物理标签。最小销售单元的物理标签上仍必须包含：产品名称、批号/序列号、失效日期、进口商名称以及必须印有“请扫描二维码获取完整说明”的泰语/英语提示。此外，AR 必须确保该电子链接在产品整个生命周期内（包括退市后 5 年）持续有效。

H
Guest

关于“家庭使用”与“专业使用”器械的语言强制性要求提问： 我们有一款半自动体外除颤器（AED），它既安装在公共场所供非专业人员使用，也提供给救护车专业医护使用。根据 2026 年 6 月生效的新规，如果该设备被界定为“家庭/公共使用（Home-use）”，是否意味着机器界面、外盒及说明书必须全部翻译成泰语？仅提供英文对照是否会被视为不合规？

ElendiLabs

根据泰国医疗器材 B.E. 2568 条例，所有“家庭使用”器械的标签和随附文件必须强制使用泰语。由于 AED 涉及非专业人员操作，TFDA 要求核心警示语、操作步骤和说明书必须有泰语版本，且泰语表达必须准确、易懂。对于公共使用的设备，建议采用泰/英双语，但泰语必须醒目。如果仅提供英文，该产品将无法通过 TFDA 的上市后监督（PMS）审查，甚至在清关时被扣留。

Need Expert Guidance?

Email Us

Contact us at contact@elendilabs.com / +852 4416 5550

Related Articles

Registration

Approximately 5 minutes

Thailand Medical Device Registration and Approval: Compliance with Thai FDA and AMDD

Thailand's regulatory process, overseen by the Thai FDA's MDCD, follows the Medical Device Act B.E. 2562 (2019) and aligns closely with the ASEAN Medical Device Directive (AMDD). Devices are classified into four risk categories (1-4) and require one of three approval routes: Listing, Notification, or License.

Registration

Approximately 5 minutes

Thailand Medical Device Classification: Risk Categories and Thai FDA Verification

Medical devices in Thailand are classified into four risk categories (Class 1-4) based on intended use, invasiveness, and risk, closely following ASEAN MDD rules. Manufacturers can formally confirm their device classification by submitting an online application to the Thai FDA.

Registration

Approximately 5 minutes

Thailand Medical Device Grouping Rules: Simplifying Registration and Saving Costs

Thailand's new grouping guidance simplifies the registration process, allowing multiple products to be included in a single submission. Devices must share a product owner, intended purpose, and proprietary name, and can be grouped as a Single device, Family, System, Set, IVD Test Kit, or IVD Cluster, subject to specific variant rules.

Medical Advertisements

Approximately 5 minutes

Thailand Medical Device Advertising Approval: Rules for DTC and HCP Communication

The Thai FDA regulates medical device advertising based on the target audience. Direct-to-Consumer (DTC) ads require prior approval, while advertisements targeted solely at Healthcare Professionals (HCPs) are generally exempt, provided they are not visible to the public. Approval licenses are valid for up to 3 years.

Post Market Surveillance

Approximately 5 minutes

Thailand Medical Device Post-Market Surveillance (PMS) and Adverse Event Reporting

The Thai FDA requires device defects and Adverse Events (AEs) occurring globally to be reported if the product is on the Thai market, following AMDD Annex 5 guidelines. The local Registration Holder is responsible for submitting reports and maintaining distribution/complaint records for at least five years.

Registration

Approximately 5 minutes

The Role of the Medical Device Control Division (MDCD) within the Thailand Food and Drug Administration (TFDA)

The TFDA is the national regulatory body in Thailand, with the Medical Device Control Division (MDCD) responsible for enforcing the Medical Device Act B.E. 2562 (2019). The MDCD oversees pre-market evaluation, registration, and post-market monitoring, ensuring medical devices comply with safety and quality standards aligned with the ASEAN MDD.

Back to Articles