泰國 IVD 體外診斷器械註冊：分類、CSDT 與當地要求

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.

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.

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。

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。

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。