泰國醫療器材分類：風險類別與泰國 FDA 驗證

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."

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.

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）。

“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。

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。