A list of recently published and updated articles regarding medical device regulatory updates from the HSA and other governing bodies in Singapore.

How New EU MDR Requirements Will Affect Registrations in Asia

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As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.

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Medical Device Advertising Requirements in Asia

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In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.

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What is CSDT Documentation?

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Manufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.”

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Asia Actual is the Best Medical Device Consulting Company in Asia

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Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”

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Singapore’s HSA Issues New Software as Medical Device (SAMD) Guidance

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In April 2022, Singapore’s Health Science Authority (HSA) issued new guidance for registering software as a medical device (SAMD) and Clinical Decision Support Software (CDSS) in Singapore.

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Singapore’s HSA to Increase Fees in July 2022

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Singapore’s Health Science Authority (HSA) to increase review fees in July 2022 by about 3%.

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Singapore’s HSA Removes Classification and Grouping Inquiry Option

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Beginning in 2022, the HSA has cease to entertain inquiries seeking confirmation of manufacturers’ classification and grouping strategy and has referred companies to their online tools and guidance documents.

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Singapore’s HSA Issues New Guidance on Special Access Routes (SAR)

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Singapore’s Health Science Authority (HSA) recently held a zoom conference call outlining the new requirements for the Special Authorization Routes GN-26 and GN-27 taking effect on April 1, 2022.

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Regulatory Spotlight: UDI Requirements in Singapore

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Singapore’s Health Science Authority (HSA) has announced that they will follow many countries example and begin implementing a Unique Device Identifier (UDI) system.

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Singapore HSA Regulations on Hand Sanitizers, Masks, Thermometers, and Protective Gear

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Hand sanitizers are not considered medical devices and therefore, do NOT need approval from the Health Sciences Authority (HSA) in Singapore.

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