Regulatory updates Archives

Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software

May 13, 2022

The Health Sciences Authority Singapore published a new guidance document titled ‘Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS). It was published in April 2022. This final version overrides an earlier draft that was sent for industry feedback in 2021. Standalone

Regulatory Guidelines for Software Medical Devices

May 9, 2022

The Health Sciences Authority Singapore has revised a guidance document to strengthen regulatory oversight on cybersecurity as well as facilitate pre-market and/or change application’s required documentation for high-risk SaMDs. The document is titled ‘Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach Revision 2.0’. It is effective from

Conformity Assessment Procedures for Medical Devices Approved by Recognized Countries

May 1, 2022

There is new guidance that is effective immediately from the Medical Device Authority (MDA) in Malaysia. It released Appendix 1,5th Revision of Circular Letter of the Medical Device Authority 2 Year 2014 (Appendix 1-Revision 4). This appendix describes the process for conducting conformity assessment by way of verification of the

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

April 25, 2022

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,

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

April 25, 2022

Malaysia’s Medical Device Authority (MDA) has released draft guidance on 12 April 2022, for labelling registered medical devices.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)

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

April 25, 2022

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

Regulatory Updates

Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software

Regulatory Guidelines for Software Medical Devices

Conformity Assessment Procedures for Medical Devices Approved by Recognized Countries

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

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

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

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