The article provides a brief overview of the approach to be applied concerning the classification of medical devices. It highlights the key points to be taken into consideration in this respect.

MDA Guidance on Establishment Licensing: Amendments

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

The document provides additional clarifications regarding the applicable regulatory requirements, as well as additional clarifications to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.

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

Regulatory Background 

The MDA of Malaysia has issued a detailed guidance document intended to facilitate the understanding and compliance of industry stakeholders and healthcare professionals with the Medical Device Act 2012 (Act 737) and its subsequent regulations.

This document provides important recommendations to be taken into consideration by the entities involved in the manufacturing, importation, exportation, or marketing of medical devices within Malaysia.

It serves as a comprehensive manual that complements the existing legal framework, including but not limited to the Medical Device Act 2012, Medical Device Regulations 2012, and regulations concerning the duties, obligations, and advertising of medical establishments.

The present guidance document emphasizes the necessity of interpreting its contents in line with prevailing laws and regulations in Malaysia.
In particular, the document is expected to clarify the obligations and allowances under the Act and its regulations.

It is also important to mention that the MDA reserves the authority to request additional information or stipulate conditions beyond those outlined in the document, ensuring a flexible and thorough regulatory oversight.

The MDA has dedicated efforts to ensure the accuracy and completeness of this guidance, acknowledging that in cases of discrepancy, the written law prevails. Additionally, as it was mentioned before, it retains the right to periodically amend the guidance to reflect evolving regulatory needs and practices.

FDA on assessing credibility of computational modelling2

Introduction to Grouping

In accordance with the applicable legislation enforced in Malaysia, the registration of medical devices is a mandatory prerequisite for their importation, exportation, or distribution. This document introduces the concept of device grouping – categorizing medical devices as SINGLE [device], FAMILY, SYSTEM, or SET for registration purposes.
This classification facilitates the application process by allowing similar or related devices to be grouped under a single application.

Scope and Application

The document’s applicability extends to all products identified as medical devices, excluding In-vitro Diagnostic Medical Devices (IVDs), with specific references for IVD and dental devices grouping provided. This inclusivity ensures that a broad range of medical devices, from simple to complex, is covered under the guidance.


In order to assist the parties involved in operations with medical devices with interpreting the provisions of the applicable legislation and following the requirements set forth therein, the present guidance provides definitions of the most important terms and concepts used in the context of the guidance. In particular, key terms such as “accessory”, “Authorized Representative”, “constituent component”, “intended use/purpose”, “manufacturer”, “proprietary name”, and “registration holder” are defined to establish a clear understanding of the criteria for grouping.

Grouping Principles

The document further outlines and delineates the general principles for grouping medical devices into SINGLE, SYSTEM, FAMILY, or SET categories, based on the relevant criteria such as proprietary name, manufacturer, and intended purpose.
This systematic approach streamlines the registration process, making it more efficient for manufacturers and regulatory bodies.


In summary, the present guidance document issued by the MDA assists the parties involved with navigating the regulatory landscape of medical devices in Malaysia. By clarifying requirements, recommendations, permissions, and possibilities, it assists the stakeholders (such as medical devices, importers, or distributors) in achieving compliance with the Medical Device Act and relevant regulations. The document describes in detail the applicable regulatory requirements to be followed, ensuring that medical devices meet the necessary standards for safety and efficacy before reaching the Malaysian market.

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