April 2022

draft for comments requirements for new in vitro diagnostic medical devices for sars cov 2

DRAFT FOR COMMENTS: REQUIREMENTS FOR NEW IN VITRO DIAGNOSTIC MEDICAL DEVICES FOR SARS-COV-2

The Philippines Food and Drug Administration (FDA) is asking for input from manufacturers, traders, and distributors (importers/exporters/wholesalers) of IVD Medical Devices (IVDMDs) on the requirements for the Special Certification of new medical technology equipment and devices. All new medical technology equipment and devices to be used for the diagnosis/screening, confirmatory, and monitoring/surveillance of SARS-CoV-2 infection …

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malaysia mda releases public comment draft medical device guidance document on requirements for labelling medical devices

Malaysia MDA Releases Public Comment Draft Medical Device Guidance Document on Requirements For Labelling Medical Devices

Malaysia’s Medical Device Authority (MDA) has released draft guidance on 12 April 2022, for labelling registered medical devices. The draft guidelines are open for stakeholder comments until 28 April 2022. This fifth edition introduces the following additions or changes: Location of Labelling General contents of labelling Instructions for use (IFU) Use of specific statements This …

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malaysia mda releases public comment draft for change notification on registered medical devices

Malaysia MDA Releases Public Comment Draft For Change Notification on Registered Medical Devices

On 6 April 2022, Malaysia’s Medical Device Authority (MDA) released draft guidance for change notification on registered medical devices. The draft guidelines are open for stakeholder comments until 20 April 2022.  This document provides guidance to determine the correct categories of changes to continue importing, exporting, or placing registered medical devices on the market. This …

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a reminder that medical devices must be registered and imported correctly

A Reminder That Medical Devices Must be Registered and Imported Correctly

Malaysia’s Medical Device Authority (MDA) issued a reminder on 5 April 2022 that imported medical devices must be registered and imported by a licensed establishment as provided in sections 5 (1) and 15 (1), Medical Devices Act 2012 (Act 737) or obtain any approval issued by MDA. If you are involved in importing medical devices, …

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medical device authority confirmed disinfectant body spray is not subject to the control of the medical devices act 2012 (act 737)

MALAYSIA MEDICAL DEVICE AUTHORITY CONFIRMED DISINFECTANT BODY SPRAY IS NOT SUBJECT TO THE CONTROL OF THE MEDICAL DEVICES ACT 2012 (ACT 737)

The Medical Device Authority (MDA) said that based on the definition under section 2 of Act 737, only disinfectants used to disinfect  medical devices are categorized as medical devices. Other disinfectant products including body spray disinfectant are not categorized as medical devices and therefore they are not subject to the control of Act 737 enforced …

MALAYSIA MEDICAL DEVICE AUTHORITY CONFIRMED DISINFECTANT BODY SPRAY IS NOT SUBJECT TO THE CONTROL OF THE MEDICAL DEVICES ACT 2012 (ACT 737) Read More »

announcement on the requirements for covid 19 self test kits

MALAYSIA ANNOUNCEMENT ON THE REQUIREMENTS FOR COVID-19 SELF-TEST KITS

The Medical Device Authority (MDA) decided on 29 March 2022  to replace the requirement of lot-to-lot variation tests. Instead, it’s instituting the approval of a new lot of COVID-19 test kits with the requirement under the post market duties and obligations of the establishment. With this arrangement, the establishment shall inform MDA of any new …

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registration of covid 19 ivd test kits

REGISTRATION OF COVID-19 IVD TEST KITS IN MALAYSIA

The MDA Covid-19 assessment Committee Of experts has agreed that all Covid-19 test kit applications pending Conditional Approval and Special Access will be halted. In addition, all future applications will be submitted using the Medcast online system. The deadline for applications pending in CA and SA is set for March 3rd, 2022. All establishments must …

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guidance on change notification for registered medical devices

Guidance on Change Notification for Registered Medical Devices

The Health Sciences Authority Singapore has published updates to the guidance document titled ‘GN-21: Guidance on Change Notification for Registered Medical Devices Revision 4.9’. This guidance document takes effect on 25 April 2022. The main update in this revision is about ‘Change in Design and/or Specifications of General Medical Devices’ where the addition of a …

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authorization for a medical device based on the asean harmonized technical requirements new guidance

Authorization For a Medical Device Based on the ASEAN Harmonized Technical Requirements: New Guidance

All Class B, C and D medical devices that are already in the Philippine market prior to the effectivity of FDA Circular 2021-002-A may continue to be manufactured, imported, exported, distributed, transferred, sold, or offered for sale without CMDN shall be extended until 31 March 2023. The Food and Drug Administration (FDA) of The Philippines …

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new guidance was issued for rehabilitation, physiotherapy, and speech therapy devices

New Guidance Was Issued For Rehabilitation, Physiotherapy, And Speech Therapy Devices

First edition guidance on the classification of rehabilitation, physiotherapy, and speech therapy devices was issued by the Ministry of Health Malaysia on 22 April 2022. The Medical Device Authority (MDA) published the guidance document to outline the terms and definitions of rehabilitation, physiotherapy, and speech therapy. This provides manufacturers and authorized representatives a guide to …

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