馬來西亞醫療器材強制性標籤要求：語言、內容與 MDA 指南

This is strictly prohibited. According to Section 4.1 of the MDA Guidance, the label must not contain any statement or logo that implies promotion or endorsement by the Ministry of Health Malaysia or the MDA. Phrases such as "Approved by MDA" or the use of their official crests are considered a violation of the Medical Device Act. You may only state the registration number in the approved format (e.g., MDA Reg. No. GXXXXX) to indicate compliance.

马来西亚的语言规则非常明确：所有家庭使用 (Home Use) 的医疗器械，其标签和使用说明书 (IFU) 必须同时具备英文和马来语。这意味着在外盒、说明书以及设备界面上，两种语言需并列显示。对于仅供医疗机构专业人员使用的器械，通常仅提供英文标签即可。鉴于您的产品具有双重用途，MDA 建议按照“家庭使用”的最高标准执行，以确保在大众市场销售时的全面合规。

这是允许的。MDA 允许在产品进入市场销售之前在本地进行加贴标签（Over-labelling）或重新包装（Repackaging）活动。但有几个关键约束：第一，该操作必须在具备相应执照 (Establishment License) 且符合良好分销规范 (GDPMD) 的场所进行；第二，加贴的标签绝对不能覆盖原厂的批号 (Lot Number)、生产日期或失效日期。此外，加贴标签的内容必须与您在注册申请时提交给 MDA 审批的模版保持 100% 一致。第三，加贴或重新贴标签的内容、格式和措辞必须与您在产品注册申请期间（通过MeDC@St）提交给MDA的标签设计/模板一致。

For professional-use devices, MDA allows the use of e-IFU, provided you conduct and document a risk assessment proving that electronic access does not compromise patient safety. However, the manufacturer/AR must still maintain the ability to provide a paper copy at no additional cost within a reasonable timeframe if requested by the user. Regarding accessibility: if the link is broken during an inspection or clinical use, it is treated as a labeling non-compliance. Therefore, you must ensure the hosting server is stable and provide clear instructions on the label on how to access the digital version offline (e.g., via a dedicated app or downloadable PDF).