泰国汞使用管制新规：禁用含汞产品与生产限制
作者：东南亚合规中心编辑团队
TL;DR · 核心要点
泰国政府出台新规，全面限制汞在工业、医疗及消费品领域的使用，旨在履行《水俣公约》义务并保护公众健康与环境。核心要求包括：自2025年1月1日起禁止进口、制造和销售含汞体温计、血压计及部分荧光灯；2026年起禁止氯碱工业使用汞法工艺；所有含汞医疗器械须于2024年底前向泰国食品药品监督管理局（TFDA）完成备案。企业需重新评估供应链、更新产品合规声明，并向工业部（MOT）及TFDA提交替代技术方案。未合规企业将面临产品下架、罚款及生产许可暂停风险，尤其影响医疗器械进口商、照明制造商及化工企业。
✅ 合规行动清单 · Compliance Checklist
- ›立即核查现有医疗器械、照明及测量设备是否含汞，并启动无汞替代品认证流程
- ›于2024年12月31日前向泰国食品药品监督管理局（TFDA）提交含汞医疗器械备案申请
- ›自2025年1月1日起停止进口或销售含汞体温计、血压计及T12/T8荧光灯管
- ›Audit all medical devices, lighting, and measuring instruments for mercury content and initiate non-mercury certification with TFDA-accredited labs
- ›Submit mercury-based medical device registration to the Thai FDA (TFDA) no later than 31 December 2024
- ›Cease import, sale, and distribution of mercury thermometers, sphygmomanometers, and T12/T8 fluorescent lamps effective 1 January 2025
English Summary
Thailand has introduced new mercury restrictions to comply with the Minamata Convention, effective in phases. Key requirements: (1) Import, manufacture, and sale of mercury-containing thermometers, sphygmomanometers, and certain fluorescent lamps are banned from 1 January 2025; (2) Mercury-cell chlor-alkali production must cease by 1 January 2026; (3) All mercury-based medical devices must be registered with the Thai FDA (TFDA) by 31 December 2024. Affected entities include medical device importers, lighting manufacturers, chemical producers, and electronics suppliers. Foreign businesses must verify product composition, update labeling and technical documentation, and engage TFDA-certified local representatives for registration. Non-compliance may trigger customs rejection, fines up to THB 200,000, and suspension of import permits. Proactive supply chain audits and substitution planning are strongly advised.
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