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January 1, 2025

Approximately 5 minutes

Thailand IVD Device Registration: Classification, CSDT, and Local Requirements

Thailand IVD Device Registration and Approval

The regulation of In-Vitro Diagnostic (IVD) devices in Thailand falls under the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (TFDA). The rules are established by the Medical Device Act B.E. 2562 (2019) and are harmonized with the regional ASEAN Medical Device Directive (AMDD).

⚙️ IVD Classification and Approval Routes

IVD devices are classified into four risk categories (1 through 4), based on factors like the intended purpose, expertise of the user, and public health impact. This risk classification determines the required approval route:

Risk ClassApproval RouteDocumentation RequirementEst. Review Time (Max Standard)
Class 1 (Low)ListingLimited Documentation200 days
Class 2 & 3NotificationCSDT Full Format250 days
Class 4 (Highest)LicenseCSDT Full Format300 days

Note: All IVD registrations are valid for five years.

📝 Submission Requirements (CSDT)

For Class 2, 3, and 4 IVDs, the application must be submitted using the Common Submission Dossier Template (CSDT) Full format. Key components of the CSDT include:

  • Executive Summary, Device Description, and Intended Use.
  • Essential Principles of Safety and Performance and conformity documentation.
  • Summary of Design Verification and Validation.
  • Risk Analysis and Labeling Details.
  • Quality Management Certification (ISO 13485) is required for Class 2-4 devices.

🧪 Special Cases and Testing Requirements

Specific high-risk IVDs may be subject to additional local requirements:

  • In-Country Testing: Some high-risk IVDs may require in-country testing as determined by the TFDA on a case-by-case basis.
  • Specific IVD Kits: Currently, HIV test kits and COVID-19 test kits and their reagents require performance test certificates issued by a local laboratory in Thailand.

🏦 License Holder Requirements

Similar to other medical devices, the IVD Import License is issued to a local, licensed company in Thailand.

  • This local entity acts as the License Holder, owns and controls the license, and is required to have an Establishment License issued by the Thai FDA.
  • The License Holder is integral to the importing process. While licenses cannot currently be transferred between holders, foreign manufacturers can designate multiple license holders for the same device at the same time.

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Questions & Answers (5)

A
Guest

For our Class 4 IVD test kits (e.g., Hepatitis B and Syphilis), is it mandatory to conduct in-country analytical performance testing at a Thai laboratory (such as the Department of Medical Sciences - DMS) as part of the Licensing process? If so, can we use the test report generated during the initial registration to satisfy the "Analytical Test Report" requirement for the periodic renewal of these high-risk kits?

ElendiLabs

For specific high-risk IVDs including HIV, HBV, HCV, and Syphilis, the TFDA often requires local batch release or independent analytical validation. During the initial registration, a test report from a TFDA-recognized Thai lab (like DMS) is usually mandatory. For renewals, according to the 2025 update, HIV test kits must always include a fresh Analytical Test Report. For other Class 4 kits, while you can often use existing data, the TFDA reserves the right to request a new local test report if there have been significant updates to international standards or if the device performance history shows any drift.

A
Guest

We hold several legacy "Listing" certificates for Class 2 IVDs issued under the old pre-2021 system. With the implementation of the SKYNET renewal portal in late 2025, if our certificates expire in 2026, are we required to upgrade the entire dossier to a Full CSDT format immediately during renewal? What are the implications if we have had a minor change in the raw material supplier that was never notified under the old system?

ElendiLabs

Under the latest TFDA policy (Sept 2025), renewals are categorized into "Full CSDT" and "Partial" groups. If your product was registered under the old system, you may be allowed to renew via a "Partial" submission, provided no serious adverse events occurred. However, any unreported change in raw materials constitutes a regulatory violation. You must rectify this by submitting a "Change Notification" before or alongside the renewal. Note that the TFDA is phasing out legacy formats; it is highly recommended to prepare a Full CSDT, as any future significant modifications will trigger a mandatory upgrade to the full harmonized format anyway.

E
Guest

我们打算通过“Reliance Program”利用已获批的新加坡 HSA 证书来加速泰国的注册。如果我们在新加坡提交的是 Abridged 路径，而在泰国提交时为了补充说明更新了部分性能验证报告（V&V Data），TFDA 是否会因为文件与 HSA 原始卷宗“不完全一致”而拒绝该简易路径，从而强制转回 Full Evaluation 路径

ElendiLabs

是的。Reliance Program 的核心要求是提交给 TFDA 的 CSDT 文件必须与提交给新加坡 HSA 的版本完全一致。TFDA 会通过官方渠道核实文件。如果 V&V 数据版本不符，或者新加坡证书中列出的型号/制造场地与泰国申请表不匹配，TFDA 会立即中止简易程序。如果您有更新的数据，建议先在新加坡完成变更备案，或者直接申请泰国的 Concise Route（基于美、欧、日等五国批准的精简审查路径），后者对文件一致性的要求相对灵活。

A
Guest

我们有一款 3 类自测型（Self-test）血糖监测系统。在提交 CSDT 文件时，TFDA 对临床评价报告（CER）是否有针对泰国本土受试者的要求？此外，关于 2025 年生效的标签新规（B.E. 2568），如果我们的主要包装空间非常小，是否可以仅在说明书（IFU）中使用泰语，而外盒标签仅保留英语？

ElendiLabs

对于自测型 IVD，TFDA 非常关注“非专业用户”的操作一致性。虽然不强制要求在泰国境内进行新的临床试验，但您的 CER 建议包含针对非专业用户（Lay User）的使用评价数据。语言方面，自测型产品（Home-use）必须强制提供泰语标签和泰语说明书。根据 2025 年新规，外盒至少要包含泰文的产品名称和预期用途，关键安全警告不能仅用英文，且必须在进口后 120 天内完成本地化贴标。

A
Guest

我们计划在泰国注册一套全自动化学发光免疫分析系统及其配套的 15 种检测耗材（涵盖肿瘤标志物和传染病筛查）。根据 TFDA 的分组规则，这些耗材是否可以作为“IVD Cluster”整体申报以节省审查费？如果其中部分传染病检测试剂属于 4 类（如 HIV），而肿瘤标志物属于 2 类或 3 类，TFDA 是否允许将其混在一个 Cluster 中进行 Notification/Licensing 申请？

ElendiLabs

泰国允许使用 IVD Cluster 分组，但必须满足“相同制造商、相同预期用途类别、相同技术原理”的前提。对于跨风险等级的产品，TFDA 的基本原则是以高定低。如果您将 2 类和 4 类试剂混在同一个 Cluster 申请，整个申请将按照 4 类（Licensing 路径）进行审核，涉及的评审费（Evaluation Fee）和周期将按最高标准执行。为了成本最优，建议将高风险试剂单独申请，而将低风险的常规检测项目组合为 Cluster。

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