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September 16, 2025

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Medical Device Grouping in Malaysia: Streamlining Registration via the ASEAN MDD Framework

Medical Device Grouping in Malaysia: Streamlining Registration via the ASEAN MDD Framework

The Malaysian Medical Device Authority (MDA) provides guidance on medical device Grouping to simplify the registration process for manufacturers. Grouping allows multiple related product variants to be submitted under a single registration application, offering a more cost-effective and time-saving approach. This guidance is harmonized with the ASEAN Medical Devices Directive (AMDD).

Core Grouping Rules

All accepted grouping categories in Malaysia are centered on three basic rules that must be met for a single application:

  1. One generic proprietary name.
  2. One manufacturer.
  3. One common intended purpose.

Accepted Grouping Categories

The MDA recognizes six main categories for grouping applications:

  • Single: A single medical device that may vary only in package size and/or number of units, while still complying with the three core rules.
  • Family: Products that share a common risk classification, manufacturer, generic proprietary name, intended use, design, and manufacturing process. They are permitted to differ only slightly from each other through Permissible Variants.
  • System: A combination of accessories and a medical device that work together to achieve a common intended purpose. The labeling and Instructions for Use (IFU) must indicate that the devices are intended to be sold as a system.
  • Set: A collection of two or more medical devices (potentially from different manufacturers) imported and sold in the same packaging with the same intended purpose, under the same proprietary set name. The risk classification is determined by the device with the highest risk.
  • IVD Test Kit: Contains reagents and/or articles meant to be used in combination for a common intended purpose. They must have a common manufacturer and a single proprietary name. (Excludes analyzers).
  • IVD Cluster: Contains in-vitro reagents and/or articles from a common manufacturer and shares a common test methodology, but may have different intended uses. These articles must be restricted to risk classification A or B.

Permissible Variants for 'Family' Grouping

The Family grouping allows for specific variations between products within the group that do not fundamentally change the device's safety or efficacy. These permissible variants include, but are not limited to:

  • Physical Properties: Color, diameter, length, size, shape, volume, width, and flexibility.
  • Technical Specifications: Gauge, isotope activity level, memory storage, print capability, and radiopacity.
  • Material: Viscosity (if the change is only due to concentration of constituent material).
  • Design: Type of device mounting (e.g., wall mount, ceiling mount) and dimensional design differences for pediatric versus adult use.
  • Product-Specific Examples: For catheters, permissible variants include the number of lumens and material (e.g., PVC, silicone); for contact lenses, diopter, UV protection, and tinting are permissible variants.

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Questions & Answers (5)

J
Guest

We have a specific surgical mesh that comes in 20 different dimensions and shapes, but they all share the exact same material composition and proprietary name. Under the "Single" device definition, if we list all 20 SKU codes under one application, will the MDA treat this as a "Single" registration with multiple variants, or will they force us into a "Family" grouping?

ElendiLabs

Because the mesh has multiple dimensions and configurations (SKUs), it cannot be registered as a "Single" device. It must be registered as a "Family". In the MDA's view, a "Single" registration is strictly for a device with one unique configuration. By choosing the "Family" grouping, you can list all 20 SKUs under one certificate. Ensure that your Table of Master Listings clearly describes each variant to avoid queries during the CAB (Conformity Assessment Body) audit phase.

O
Guest

我们计划在马来西亚销售一套“口腔护理包（Set）”，其中包含医疗器械（如牙科探针）和非医疗器械（如普通口腔清洁巾、塑料托盘）。在 MeDC@St 系统中申报时，我们是否需要为每一个非医疗器械组件提供技术文件？如果未来我们更换了托盘的供应商，是否需要触发变更申请（Change Notification）？

ElendiLabs

在申报“Set”时，您必须在申请表中列出所有组件。对于非医疗器械组件，不需要提供像器械那样的完整技术文件，但需要提供其规格说明和安全声明。关于变更，如果更换的非医疗器械组件（如托盘）不影响整体包件的灭菌状态或核心功能，通常只需在年度报告中备案或作为微小变更。但如果涉及供应商变更影响了质量管理体系，则建议先咨询您的授权代表（AR）。

A
Guest

我们的内窥镜成像系统包含摄像主机（A 工厂生产）和冷光源（B 工厂生产）。这两个工厂都属于同一母公司。在这种情况下，我们可以将其作为一个“System”进行分组吗？MDA 对标签上的制造商地址一致性有何具体要求？

ElendiLabs

马来西亚对“同一制造商”的定义非常严格。如果标签上显示的制造商名称和地址不完全一致，通常不能划入同一个“System”。如果 A 和 B 是不同的生产场地，但由同一个“法定制造商（Legal Manufacturer）”负责质量控制，那么标签上必须统一标注该法定制造商的地址。如果标签显示了不同的制造地址，MDA 通常会要求拆分申请。

E
Guest

我们有一款导管产品，其基本型属于 B 类（Class B），但带涂层的高端型号因为药械组合属性被定为 C 类（Class C）。虽然它们的制造工艺和预期用途基本一致，我们是否可以将它们放在同一个“Family”中进行注册，以节省一份注册费？

ElendiLabs

不可以。 根据 MDA 的规定，“Family”分组的首要条件是所有成员必须具有相同的风险等级。即使产品名称、制造商和设计理念完全一致，只要风险等级不同，就必须拆分为两个独立的申请。强行合并会导致申请在初审阶段被退回，浪费时间和评审费。

A
Guest

We provide a range of reagents for clinical chemistry that use the same methodology and instrumentation but target different analytes (e.g., Glucose, Cholesterol, Albumin). Should we register these as an IVD Test Kit or an IVD Cluster?What is the impact on the MeDC@St listing if we decide to add a new analyte reagent to this group six months after the initial approval?

ElendiLabs

These should be registered as an IVD Cluster. An IVD Test Kit is a collection of components used together to perform a specific test, whereas an IVD Cluster consists of reagents that share a common methodology and manufacturer. The primary benefit of a "Cluster" is its flexibility: if you add a new analyte (e.g., Creatinine) later, you can usually perform a Category 2 (Minor) Change Notification to add the new member to the existing certificate, which is much faster and cheaper than a new registration.

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