The Medical Device Control Division, Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health issued an announcement on the Thailand FDA – HSA Singapore Regulatory Reliance implemented for Class 2-4 IVDs and non-IVDs medical devices effective from 1 June 2022. The registrant in Singapore who obtained
Learn about the updates to dental laboratory regulatory requirements, as announced by Health Sciences Authority (HSA) Singapore on 10th May 2021.
Learn about the updates to dental laboratory regulatory requirements, as announced by Health Sciences Authority (HSA) Singapore on 10th May 2021.
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
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
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
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