MALAYSIA: Harmonised Borderline Product in ASEAN – January/February 2024

• 2024-01-26 05:18:26

The Medical Device Authority (MDA) published a second edition guidance document on “Guidance on Harmonised Borderline Product in ASEAN" on December 23, 2023. This guidance document provides a list of borderline products, whether they are medical devices or non-medical devices, based on their intended purpose as claimed by the manufacturer, which is harmonised in ASEAN. This guidance document will be updated on a yearly basis to reflect the latest decisions of the ASEAN Medical Device Committee (AMDC).

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MDR: Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices – October/November 2022

• 2022-10-25 07:05:56

This document provides borderline cases and classification cases, for which the competent authorities of the Member States find difficulty regarding the uniform application of the regulations.

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MDR: MDCG 2022-5 Guidance on Borderline Between Medical Devices and Medicinal Products under Regulation (EU) 2017/745 on Medical Devices – June, 2022

• 2022-06-29 02:11:11

MDCG 2022-5 is a guidance which provides elaboration of the borderline between medical devices and medicinal products, including relevant definitions and examples for these types of products, such as herbal products, substance-based devices and medical device and medicinal product combinations.

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