泰國醫療器材分組規則：簡化註冊並節省成本

To group as an IVD Cluster, the detection principle and manufacturer must be identical. If you have different principles (Colorimetric vs. Enzymatic), you must split them into two Clusters. Regarding the Calibrator: If it is a shared component used by all reagents in the Cluster, you can list it as a "Shared Component" within the Cluster application at no extra cost. However, if that same calibrator is sold separately for use with other systems, it requires its own separate registration. Note that a Class 4 reagent in a Cluster will pull the entire administrative review of that Cluster into the Licensed (Class 4) timeline and fee structure.

If the software is available for purchase and use independent of the hardware, it is highly recommended to register the software as a Single SaMD and the hardware as another Single device. If you group them as a System, any major update to the Class 3 software will "lock" the hardware's license during the amendment review period, potentially disrupting your hardware sales. For AI-driven software, TFDA's 2026 guidelines require a specific Software Change Management Protocol. By keeping them separate, you can update the software version via a more agile SaMD amendment process without affecting the hardware's market status.

TFDA 允许将这些产品作为 Set 分组。根据“以高定低”原则，整个 Set 将按照 第 3 类（Licensed） 进行审批，并缴纳最高等级的评审费。关于变更，如果 Set 中的 1 类组件发生变动但不影响核心植入物的临床性能，通常仍需提交 Change Notification。但在 2026 年的 Skynet 数字化系统下，此类非核心组件的微小变动可以走简易备案路径，前提是您在初始 CSDT 文件中清晰界定了各组件的物料清单（BOM）。

不能。Family 分组的核心要求是：1. 风险等级必须一致；2. 预期用途必须一致。 即使材质相同，由于含银涂层具备抗菌功能（属于 3 类），而普通敷料仅为物理覆盖（属于 2 类），TFDA 要求必须拆分为两个 Family。此外，形状的不同（Variant）只要不改变基本设计原理，可以在同一个 Family 证下通过增加 SKU 列表来体现。