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).

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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.

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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.