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
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
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Malaysia’s Medical Device Authority (MDA) has released draft guidance on 12 April 2022, for labelling registered medical devices.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)
On 6 April 2022, Malaysia’s Medical Device Authority (MDA) released draft guidance for change notification on registered medical devices.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
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
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