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MALAYSIA: MDA Update 4th Edition of MDA/GD/0020: Change Notification for Registered Medical Device – December 2022/January 2023

MALAYSIA: MDA Update 4th Edition of MDA/GD/0020: Change Notification for Registered Medical Device – December 2022/January 2023

  • 2022-12-27 05:48:52

The Malaysia Medical Device Authority (MDA) released the latest 4th Edition Change Notification for Registered Medical Device, MDA/GD/0020. More substantial changes were made compared to the 3rd Edition. There are new additional clauses and updated documents requirements. The MDA revised the turn-around time for Category 2 and Category 3. Furthermore, some changes do not require a change notifications to be submitted to MDA.

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MALAYSIA: MDA Announced the New Guidance on Requirements for Labelling of Medical Devices – December 2022/January 2023

MALAYSIA: MDA Announced the New Guidance on Requirements for Labelling of Medical Devices – December 2022/January 2023

  • 2022-12-27 05:37:15

The Malaysia Medical Device Authority (MDA) published the updated Sixth Edition Guidance Document, “Requirement for Labelling of Medical Device” (MDA/GD/0026), on November 21, 2022. MDA has made a few changes, respectively. MDA/GD/0026 is intended to assist manufacturers and authorized representatives with guidance on the content of medical device labelling. Labelling is used to both identify particular medical devices and to convey safety and performance-related information to patients or users of medical devices.

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MALAYSIA: MDA Updates the Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027) – November/December 2022

MALAYSIA: MDA Updates the Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027) – November/December 2022

  • 2022-11-29 02:42:41

The Medical Device Authority (MDA) updates the guideline for Licensing for Establishments. The establishment must comply to Medical Devices (Duties and Obligations of Establishments) Regulations 2019 that stipulates the post marketing requirements of medical devices. The Medical Device Authority (MDA) created this guidance document to assist the healthcare sector and the industry in their efforts to comply to the Medical Device Act's (Act 737) laws and requirements.

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MALAYSIA: MDA Announced the New Guidance on Harmonized Risk Classification of Medical Devices – October/November 2022

MALAYSIA: MDA Announced the New Guidance on Harmonized Risk Classification of Medical Devices – October/November 2022

  • 2022-10-25 06:38:16

The MDA published the First Edition of the Guidance Document of the "Harmonized Classification of Medical Devices in ASEAN" (MDA/GD/0062) on September 5, 2022. This guidance document provides the harmonized list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices, based on their intended use or purpose as claimed by the manufacturer.

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MALAYSIA: New Guideline Document MDA/GL/08: Re-Registration Of Registered Medical Devices – July 2022

MALAYSIA: New Guideline Document MDA/GL/08: Re-Registration Of Registered Medical Devices – July 2022

  • 2022-07-26 11:19:48

The Medical Device Authority (MDA) published a guideline document to provide information and explanation to establishments on how to submit a re-registration of registered medical device applications in Malaysia. The document prescribes the requirements for re-registration of registered medical devices for medical device registration applications that are about to expire or have already expired.

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MALAYSIA:  MDA Introduces New Guidance Document MDA/GD/0061: Classification of Rehabilitation, Physiotherapy And Speech Therapy Device – June, 2022

MALAYSIA: MDA Introduces New Guidance Document MDA/GD/0061: Classification of Rehabilitation, Physiotherapy And Speech Therapy Device – June, 2022

  • 2022-06-29 02:17:39

In April 2020, the Medical Device Authority (MDA) has issued a new Guidance Document regarding the classification of Rehabilitation, Physiotherapy, and Speech Therapy Devices (MDA/GD/0061). This document guides the manufacturers and authorised representatives on classifying rehabilitation, physiotherapy, and speech therapy as medical devices.

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