The Health Sciences Authority of Singapore (HSA) has revised the GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices as of 31 July 2023. This guidance will be applicable to any entity who performs manufacturing, importing, and supplying by wholesale of the medical devices. The following are
Medical Device Authority (MDA) has released a draft guidance document titled ‘Importation of Medical Device for Personal Use’ for public review and feedback. The guidance document will be applicable to all home use medical devices that fall within the definition of a medical device, as defined in MDA/GD/0006: Definition of
On 13 July 2023, The Ministry of Communication and Informatics (Kominfo) issued a draft regulation concerning Technical Standards for Telecommunication Equipment and/or Equipment Short Distance Telecommunications Devices. The proposed guidelines will revoke several regulations including SDPPI regulation no 161 Year 2019, the main reference in the registration of Short-Range Devices
In the interest of consumer protection and to ensure the quality, efficiency, and safety of medical device production, the Thai FDA released a draft public health announcement and guideline to establish a quality system for producing medical devices on 19 July 2023. Should the final announcement and guideline be approved
In the interest of consumer protection and to ensure the standardized quality, efficiency, and safety of importing or selling medical devices, the Thai FDA released a draft announcement and guideline on the Quality Management Systems for Importing and Selling Medical Devices on 19 July 2023. Should the final announcement/guideline be
On 27 June 2023, the Ministry of Health (MoH) of Indonesia invited relevant stakeholders to gather input on the Draft Guidelines for Halal Manufacturing Practices for Drugs, Biological Products, and Medical Devices, as well as the Inclusion of Information on the Origin of Ingredients for Medical Devices. Andaman Medical Indonesia
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