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August 16, 2025
Approximately 5 minutes
Medical device labeling in Malaysia is strictly regulated by the Medical Device Authority (MDA) through its official Guidance Document. Adherence to these requirements is mandatory before a product can be imported and placed on the market. The labeling must be appropriate for the device, containing enough information for the user to safely identify and use the product.
The following information, at minimum, must be included on the label or packaging:
Note: Labels must not claim promotion or endorsement by the Ministry of Health (MoH) or the MDA.
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ElendiLabs
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.
samsonkang
我们有一款既卖给医院也直接卖给消费者的理疗设备。如果该设备被定义为“家庭使用 (Home Use)”，是否意味着所有的包装信息（包括警告语和禁忌症）都必须翻译成马来语（Bahasa Malaysia）？对于专业医护人员使用的部分，是否可以仅保留英文？
ElendiLabs
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。
Anonymous
我们的全球供应链目前无法在原产地工厂完成马来西亚专属标签的印刷。我们是否可以将带有全球通用包装的货物先运抵马来西亚，在授权代表 (AR) 的本地仓库中进行补加贴标签（如加贴包含 AR 信息和注册号的贴纸）？这是否会被视为“非法拆改包装”？
ElendiLabs
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。
Anonymous
Our surgical laser system is a complex Class C device intended solely for professional use. To reduce paper waste, can we replace the physical 100-page manual with an e-IFU (via a web link on the device)? If so, are we required to provide a paper copy upon request, and what happens if the online link becomes inaccessible during an MDA post-market inspection.
ElendiLabs
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).
Approximately 5 minutes
Medical device registration in Malaysia is mandatory, managed by the **Medical Device Authority (MDA)**, and requires a local **Malaysia Authorized Holder (MAH)** to submit via the **MEDCAST** system. Classification follows **AMDD/GHTF** (Classes A-D), with faster review times (6-8 weeks for Class A; 3-6 months for others) and provisional registration granted under the **Fast Track System** based on **Reference Country** approvals.
Approximately 5 minutes
In Vitro Diagnostic (IVD) product registration in Malaysia is managed by the **Medical Device Authority (MDA)** and requires a local **Authorized Representative** to submit via the **MEDCAST** system. **Class A** devices (non-measuring, non-sterile) are exempt. Other classes are eligible for a **Fast Track Provisional Registration** (up to 5 years) based on **Reference Country** approval, while all must document quality compliance with **ISO 13485**.
Approximately 5 minutes
Malaysia’s Medical Device Authority (MDA) classifies devices into risk categories **A, B, C, and D** (low to high), plus a separate **Combination Device** class, based on the **ASEAN Medical Devices Directive (AMDD)**. Classification is determined by factors like intended use, duration of contact, invasiveness, and local vs. systemic effects, with more documentation required as risk increases.
Approximately 5 minutes
The Malaysian Medical Device Authority (MDA) allows manufacturers to streamline registration through **Grouping**, which is harmonized with the **ASEAN MDD**. All groupings (Single, Family, System, Set, IVD Test Kit, IVD Cluster) must adhere to three core rules: **one generic proprietary name, one manufacturer, and one common intended purpose**. The Family grouping allows for multiple 'Permissible Variants' like size, color, and certain design differences under a single application.
Approximately 5 minutes
In Malaysia, maintaining a medical device license requires the license holder to report all changes via the **Change Notification (CN)** process through the **MedC@st 2.0** portal. Changes are categorized into three types: **Category 1** (requires new registration for major changes), **Category 2** (requires MDA endorsement for moderate changes), and **Category 3** (minor administrative changes that can be implemented immediately with notification).
Approximately 5 minutes
The MDA mandates Post-Market Surveillance (PMS) for medical devices in Malaysia, requiring manufacturers to report Adverse Events (AEs) within strict timelines: **48 hours** for public health threats, **10 days** for death/serious deterioration, and **30 days** for potential serious injury recurrence. The **Malaysia Authorized Representative** is responsible for communicating all post-market vigilance to the MDA.
jamie
We would like to highlight the quality of our device by including the official logo of the Ministry of Health (MOH) or the Medical Device Authority (MDA) on our packaging to show it is a "Certified Product”. Is there a specific high-resolution logo provided by MDA for manufacturers to use on their local labeling, and are there any restrictions on the phrasing of such claims?