May 2022

malaysia mda releases second edition of guidance on the rules of classification for general medical devices

MALAYSIA MDA Releases Second Edition Of Guidance On The Rules Of Classification For General Medical Devices

Malaysia’s Medical Device Authority (MDA) published the 2nd Edition GUIDANCE ON THE RULES OF CLASSIFICATION FOR GENERAL MEDICAL DEVICES MDA/GD/0009 on 9th May 2022.   The document aims to provide clear guidance to manufacturers and establishments on how to determine the classification of medical devices. It also aims to allocate its medical device to an appropriate …

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singapore’s health sciences authority (hsa) issues new guidance

Singapore’s Health Sciences Authority (HSA) Issues New Guidance

Health Sciences Authority (HSA) of Singapore has made minor updates to the guidance document titled ‘GN-09: Guidance on the Component Elements of a Dear Healthcare Professional Letter Revision 3.6’. This guidance document takes effect on 09 May 2022. It is now a requirement to include the dealer’s contact information to facilitate further information. In addition, …

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guidelines on risk classification of standalone medical mobile applications and qualification of clinical decision support software

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

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 Medical Mobile Application (SaMD) The …

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regulatory guidelines for software medical devices

Regulatory Guidelines for Software Medical Devices

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 29 April 2022. The latest …

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conformity assessment procedures for medical devices approved by recognized countries

Conformity Assessment Procedures for Medical Devices Approved by Recognized Countries

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 evidence for medical devices that …

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