The article describes in detail certain aspects to be considered when applying grouping criteria for medical devices intended to be marketed and used in Malaysia.

MDA Guidance on Establishment Licensing: Amendments

The Medical Device Authority (MDA), a Malaysian regulatory agency in healthcare products, has published a guidance document dedicated to the medical device grouping.

The document provides additional clarifications regarding the applicable regulatory requirements and further clarifications to be considered by medical device manufacturers and other parties involved to ensure compliance with them.

The authority also reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. 

In particular, the document provides additional clarifications regarding medical device categories, including sets, systems, and families.

Medical Device Categories: Key Points

The MDA of Malaysia has delineated specific categories under which medical devices can be grouped for registration.
Single, System, Family, and Set categories are defined based on various criteria such as manufacturer, intended use, and the relationship between constituent components or devices.

This structure is designed to streamline the registration process and ensure that medical devices are correctly classified, facilitating regulatory oversight and market surveillance.

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Single Medical Devices

According to the guidance, a Single medical device is identified by a unique proprietary name and is intended for a specific purpose.
It is distinct in its packaging and may come in various sizes but does not fit the criteria of a family, system, or set.

Examples include varying package sizes of condoms, standalone software for medical use, and individual components of a first aid kit when sold separately.
This category underscores the importance of registering each unique product to ensure regulatory compliance and safety.

System Medical Devices

As further explained by the authority, a system comprises multiple medical devices and accessories from the same manufacturer, intended to be used together for a common purpose and compatible as a complete system.

Such systems are sold under a unified system name, and constituent components must be specified for use within this system only.

Examples include hip replacement systems and electrosurgical units with their accessories. This category emphasizes compatibility and unified use, ensuring that all components work seamlessly to achieve the intended medical outcome.

Family of Medical Devices

A family group of medical devices with the same manufacturer, risk classification, proprietary name, intended purpose, design, manufacturing process, and permissible variants.

This grouping allows for slight variations within a defined scope, such as color or size, provided these do not alter the device’s overall use and safety profile. Examples include various types of condoms, IV administration sets, and guidewires that, despite minor differences, are manufactured similarly and serve the same purpose.

This category facilitates the management of closely related products under a single registration, enhancing regulatory efficiency.

Set of Medical Devices

As the guidance states, a Set is a collection of two or more medical devices packaged together by a manufacturer for intended everyday use.

The highest classified device within it determines the classification of a set. Sets can vary in the number and combination of devices included, allowing customization to meet specific needs, such as for hospitals or physicians.

Examples include first aid kits and surgical dressing trays.
This category highlights the flexibility in product offering while ensuring that each combination meets regulatory standards.


In summary, categorizing medical devices into Single, System, Family, and Set constitutes a comprehensive framework that addresses the complexity and diversity of medical devices used in the healthcare industry.
By establishing clear definitions and examples for each category, the MDA ensures manufacturers can accurately classify their products, facilitating a streamlined registration process.
This approach enhances regulatory compliance and product safety and supports the effective monitoring and management of medical devices in the Malaysian market.

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