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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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MALAYSIA:  Update of Conditions of Conditional Approval Letter – May, 2022

MALAYSIA: Update of Conditions of Conditional Approval Letter – May, 2022

  • 2022-05-26 13:54:50

The Malaysian Medical Devices Authority (MDA) has decided to replace the requirement for lot-to-lot variation testing for the approval of new lots of COVID-19 test kits with the requirement under the establishment's post-market duties and obligations. With these, the establishment need to notify MDA of any new lot of the test kit that will be placed in the market.

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