泰國醫療器材註冊與批准：符合泰國 FDA 和 AMDD 規範

While the Thai FDA is modernizing, a physical Thai IFU is still generally required for Class 2-4 devices. e-IFU are usually allowed for software, applications, or similar entities packaged in physical form, but the labeling on the physical packaging must still be present. Regarding dates, the international YYYY-MM-DD format is perfectly acceptable and widely used. You do not need to convert dates to the Buddhist Era (e.g., 2026 to 2569 B.E.), but you must ensure that the labels include the local importer's name, address, and the Thai FDA registration number.

In Thailand, the license belongs to the local applicant. A transfer is only possible if the current license holder signs a Letter of Consent to transfer the license to a new entity. If the relationship turns hostile and they refuse to sign, you cannot simply "transfer" the file; you would have to submit a new application from scratch. To mitigate this risk, many foreign manufacturers use a neutral third-party license holder (an Independent License Holder) who is not involved in sales, ensuring you maintain control over your market access.

是的，泰国FDA 设有“简易路径”，针对已获得 HSA（新加坡）、TGA（澳大利亚）、Health Canada（加拿大）、MHLW（日本）或欧盟公告机构批准的产品。通过该路径，技术审查时间可从标准的 150-200 个工作日大幅缩短至 60-90 个工作日。虽然仍需提交 CSDT 格式的文件，但对于性能评价和临床数据部分的审核会大幅简化，因为泰国FDA 将主要参考前述机构的评估报告。

泰国已加入《海牙公约》，因此现在接受 Apostille（附加减证）形式的公证。对于电子版 CFS，必须确保其验证链接长期有效。关于产地不一致的问题，泰国FDA 非常敏感。如果 CFS 签发国与实际原产国不同，您必须额外提供一份由原产国监管机构签发的“制造证明”（Manufacturer's Certificate）或 ISO 13485 证书，证明该工厂处于有效监管之下，并提交一份详细的法律关系说明函。

泰国FDA 允许按照“系列”、“系统”或“成套工具”进行分组。对于包含不同风险等级组件的“System”或“Set”，通常按最高风险等级（即 4 类）进行整体申报。这样做的好处是只需支付一份注册费（License Fee），但缺点是所有组件必须在同一技术文件下维护。如果未来只需更新 1 类器械，由于其被捆绑在 4 类证下，审批周期仍可能长达 8-10 个月。