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February 1, 2025

Approximately 5 minutes

Thailand Medical Device Classification: Risk Categories and Thai FDA Verification

Thailand Medical Device Classification System

Medical device classification in Thailand is administered by the Thai Food and Drug Administration (TFDA) and follows a risk-based approach closely aligned with the ASEAN Medical Device Directive (AMDD). Classification determines the regulatory route required for market authorization: Listing, Notification, or License.

⚙️ Risk Categories (Class 1-4)

Devices are classified into four categories, ranging from the lowest risk (Class 1) to the highest risk (Class 4). The primary factors considered for classification include:

  • Intended Use: The purpose and indications of the device.
  • Risk Level: The potential harm posed to the patient and user.
  • Delivery Method: How the device is introduced (e.g., non-invasive, surgically invasive).
  • Invasiveness: The degree of penetration into the human body.
Risk ClassRisk LevelRequired Approval Route
Class 1Lowest RiskListing Approval
Class 2Low to Moderate RiskNotification Approval
Class 3Moderate to High RiskNotification Approval
Class 4Highest RiskLicense Approval

🔬 IVD Classification Rules

In-Vitro Diagnostic (IVD) devices are also classified into the same four categories (1 through 4), with specific rules guided by the AMDD. Factors unique to IVD classification include:

  • Expertise of the User: Whether the device is for self-testing or professional use.
  • Public Health Impact: The consequence of an incorrect result on the individual and public health.
  • Examples of High-Risk IVDs (Class 4 License): Tests for transmissible agents like HIV, HCV, and HBV.

🌐 Official Classification Verification

To avoid misclassification, manufacturers can formally query the Thai FDA to confirm their product's classification and grouping:

  1. Online Submission: The applicant submits a classification request via the electronic system (e-submission portal).
  2. Review Process: The TFDA officer reviews the submitted intended use, materials, and risk profile based on the classification rules.
  3. Certification: Upon approval, the applicant receives an official document certifying the medical device's risk classification and grouping. This process requires paying both a submission fee (1,000 THB) and an approval fee (500 THB).

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Questions & Answers (5)

A
Guest

We intend to use the TFDA-HSA Regulatory Reliance Program to expedite the licensing of our Class 4 heart valves. If our Singapore HSA approval was based on an "Abridged" evaluation, does Thailand still grant us the expedited review? Furthermore, if our Thai labeling contains minor marketing claims not present in the Singapore version, will this "inconsistency" disqualify us from the Reliance Program and force a Full Evaluation?

ElendiLabs

The Reliance Program is specifically designed for products already approved by the Singapore HSA. However, the TFDA is very strict about document identity. The CSDT submitted to Thailand must be identical to the version approved by HSA. If your Thai labeling or IFU includes "promotional claims" or "new indications" that were not part of the HSA-approved dossier, the TFDA will treat it as a discrepancy and likely move your application to the Full Evaluation route, which takes significantly longer (approx. 200–300 days). To stay on the fast track, it is best to keep the Thai labeling strictly aligned with the HSA version and add marketing claims later via a "Change Notification."

A
Guest

Our orthopedic implant portfolio was registered under the old "Group III" (General Medical Device) system before 2021. As our certificate is set to expire in late 2026, do we need to re-classify these as Class 3 or Class 4 based on the new risk rules (Rule 8 for implants)? If we choose to group them as a "System" rather than "Single" items, can we reuse our old ISO 13485 audit reports, or does TFDA require a fresh CSDT format for the renewal-as-new process?

ElendiLabs

n 2026, the TFDA no longer accepts "simple renewals" for legacy Group III items that are now high-risk. You must undergo Re-registration using the full CSDT (Common Submission Dossier Template) format. Based on Rule 8 (long-term surgically invasive devices) of the ASEAN risk-based classification, most orthopedic implants will fall into Class 3, or Class 4 if they are bio-absorbable or contact the central nervous system. Regarding grouping, you can definitely register them as a "System" or "Family", but your ISO 13485 must still be valid. The TFDA will scrutinize the "Summary of Design Verification and Validation" section in the CSDT, so simply reusing old reports without mapping them to CSDT requirements will likely result in a query.

Y
Guest

我们计划在泰国注册一款含有纳米银涂层的伤口敷料。尽管它属于 3 类产品，但听说这类含有“创新材料”的产品经常被 TFDA 要求进行专家评审。请问 2026 年最新的“专家审查”触发清单中是否包含纳米材料？如果我们已经获得了新加坡 HSA 或美国 FDA 的 3 年以上销售许可，是否可以申请豁免这笔高达 53,000 泰铢的专家费？

ElendiLabs

是的，纳米材料和药械组合产品（如含银、含药敷料）很大机会会触发 Specialist Review，这会为注册周期额外增加 3-6 个月。豁免路径是存在的：如果您能证明该产品在参考国家（如美国 FDA、新加坡 HSA、欧盟、澳洲、日本或加拿大）已获批且上市满 3 年（或在多个参考国获批满 1 年），且其预期用途与泰国申请完全一致，则可以申请免除专家评审费并走精简评估路径（Concise Route）。

A
Guest

2026 年 B.E. 2568 标签新规下的“家庭使用”认定提问： 我们有一款 2 类红外体温计，主要销往药店供消费者购买。根据 2026 年 6 月生效的新标签法，如果我们的外盒已经包含了英语的所有必要信息，是否仍需强制印刷泰语标签？如果产品被认定为“家庭使用（Home-use）”，TFDA 对于泰语说明书（IFU）的字号或排版是否有特定强制标准？

ElendiLabs

“家庭使用”设备要提供泰语标签和说明书。英语不能替代泰语，只能作为并列语言。对于 2 类设备，虽然字号没有像处方药那样细致的毫米级规定，但要求必须“清晰易读且不产生歧义”。关键点在于，新规缩短了进口后的贴标宽限期——您必须在货物进入泰国海关后的 120 天内（原为 180 天）完成泰语标签的加贴工作，否则将面临罚款或吊销证书。

E
Guest

我们开发了一款基于 AI 的辅助诊断软件，用于在 ICU 环境下监测患者的生命体征并预警败血症风险。根据 TFDA 2024 年发布的《SaMD 指南》，如果该软件仅提供“监测建议”而非“自动触发治疗”，它会被归为 2 类（Notification）还是 3 类（Notification）？另外，针对 2026 年的申报，我们是否必须披露 AI 模型训练所用的数据集来源？

ElendiLabs

这是一个典型的规则 10(1) 判定问题。如果软件监测的是“重要生理参数”，且其结果可能导致患者处于即刻危险（Immediate Danger）境地（如 ICU 败血症预警），TFDA 通常会将其判定为 3 类。针对 2026 年的申请，TFDA 明确要求在技术文件中包含 AI/ML 透明度报告，您必须披露数据集的构成（如族裔分布、样本量）以及如何处理算法偏见。即使不涉及自动治疗，关键生命体征的诊断逻辑也属于高风险监控范畴。

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