On 29 June 2022, Health Sciences Authority (HSA) Singapore published an update to guidance document, GN-32 GUIDANCE FOR IMPORTATION OF UNREGISTERED MEDICAL DEVICES FOR EXHIBITION IN SINGAPORE Revision 4. Regardless of risk class, unregistered medical devices (human use) for exhibition, are subjected to regulatory controls under the Singapore’s law. Applicants are required to obtain an […]
FDA Circular No.2022-003 MARKETING AUTHORIZATION & DISTRIBUTION/OFFER FOR SALE The Philippine Food and Drug Administration (FDA) has announced a notice to the public regarding the banning of all mercury-added thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes. This Circular aims to totally ban the manufacture, importation, exportation, distribution, sale,
First edition guidance on the re-registration of registered medical device was issued by the Ministry of Health Malaysia on 3 June 2022. The Medical Device Authority (MDA) published the guidance document to provide information and explanation to the establishment on how to submit re-registration of registered medical device application under Act 737 and MDR 2012
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 the medical device license from
Thailand and Singapore: FDA – HSA Singapore Regulatory Reliance Read More »
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.
Singapore: Dental Laboratory Regulatory Requirements In Singapore Read More »
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